Paulness
4 years ago
NEWS -- Relmada Therapeutics Announces Initiation of Phase 3 Program for REL-1017 as Adjunctive Treatment for Patients with Major Depressive Disorder
NEW YORK, Dec. 7, 2020 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced that the first patient has been enrolled in the first Phase 3 clinical trial (RELIANCE I) for the Company's lead product candidate, REL-1017, as an adjunctive treatment for major depressive disorder (MDD).
"The initiation of our Phase 3 program for REL-1017 represents a significant operational milestone for our company," said Sergio Traversa, CEO of Relmada Therapeutics. "Importantly, the design of the Phase 3 program incorporates valuable guidance from the U.S. Food and Drug Administration (FDA) obtained in our successfully completed End-of-Phase 2 meeting. We believe that the reported positive Phase 2 results are indicative of the potential of REL-1017 to treat patients suffering from MDD. We look forward to the availability of top-line results from RELIANCE I in the first half of 2022."
"A significant unmet medical need continues to exist for therapeutics that demonstrate a rapid and robust antidepressant effect in patients with MDD, especially for patients who do not respond adequately to their first line of treatment. We are hopeful for the results of the RELIANCE trials and that in the near future physicians will have access to this novel treatment in their armamentarium " said Maurizio Fava, M.D., Chief of the Department of Psychiatry at Massachusetts General Hospital, and Principal Investigator for the REL-1017 Phase 3 program. "This important Phase 3 program provides us with an opportunity to confirm and further show the effect of REL-1017 in the treatment of MDD, a devastating and life altering condition with many sequelae. I am inspired and excited to continue evaluating this promising product candidate in late-stage clinical trials" said Marco Pappagallo, M.D. acting Chief Medical Officer of Relmada Therapeutics.
Key points of the Phase 3 program agreed upon in discussions with FDA include:The Phase 3 program will consist of two sister, two-arm, placebo-controlled clinical trials. Each trial will be conducted in 55 clinical sites in the United States and will include approximately 400 MDD patients with inadequate response to standard antidepressants in their current depression episode. Patients will add either a 25 mg oral dose of REL-1017 once per day or placebo to their ongoing antidepressant treatment.The primary endpoint to be evaluated will be the change from baseline on the Montgomery and Asberg Depression Rating Scale (MADRS) score at day-28 for REL-1017 compared to placebo. Success on this endpoint with the collection of sufficient safety data would support the use of REL-1017 for chronic treatment, if approved.The change from baseline and the 7-day MADRS score will serve as a key secondary endpoint and will provide data on the rapid onset of treatment effect; statistically significant separation between REL-1017 and the control group was achieved by day 4 in the Phase 2 proof-of-principle trial completed in 2019.The Company expects to initiate the second Phase 3 trial, RELIANCE II, in the first half of 2021. Patients who complete RELIANCE I and RELIANCE II will be eligible to rollover into the long-term, open-label study, which is also expected to include subjects who had not previously participated in a REL-1017 clinical trial.Upcoming anticipated milestones for REL-1017 include:1H21 – Start of RELIANCE II, the second pivotal Phase III adjunctive MDD trial1H21 – Start of Phase II monotherapy MDD trial2Q21 – Results of human abuse potential studies4Q21 – Results of Phase II monotherapy MDD trial1H22 – Results of RELIANCE I and RELIANCE II adjunctive MDD trialsAbout REL-1017
REL-1017, a novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission, is entering late-stage studies as an adjunctive treatment for MDD in adults. Our clinical program for REL-1017 will evaluate its potential as the first rapid-acting, oral, once-daily antidepressant treatment. In a Phase 2 trial, REL-1017 demonstrated rapid onset and sustained antidepressant effects with statistically significant improvements as compared to placebo. The Phase 2 study also confirmed the favorable safety and tolerability profile of REL-1017 observed in previously completed Phase 1 studies. In April 2017, the FDA granted Fast Track designation for REL-1017 for the adjunctive treatment of major depressive disorder.
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a late-stage biotechnology company addressing diseases of the central nervous system (CNS), with a focus on major depressive disorder (MDD). Our experienced and dedicated team is committed to making a difference in the lives of patients and their families. Relmada' s lead program, REL-1017, is a novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission. REL-1017 has entered late-stage development as an adjunctive treatment for MDD in adults.
Forward-Looking Statements
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding the expected use of the proceeds from the offering. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as "expects," "anticipates," "believes," "will," "will likely result," "will continue," "plans to," "potential," "promising," and similar expressions. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including the risk factors described under the heading "Risk Factors" set forth in the Company's reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be a complete list.
Investor Contact:
Tim McCarthy
LifeSci Advisors
212-915-2564
mailto://tim@lifesciadvisors.com
Media Inquiries:
FischTank PR
mailto://relmada@fischtankpr.com
View original content to download multimedia: http://www.prnewswire.com/news-releases/relmada-therapeutics-announces-initiation-of-phase-3-program-for-rel-1017-as-adjunctive-treatment-for-patients-with-major-depressive-disorder-301187305.html
SOURCE Relmada Therapeutics, Inc.
Paulness
4 years ago
NEWS -- Relmada Therapeutics to Participate in Upcoming Investor Conferences
NEW YORK, Nov. 17, 2020 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a clinical-stage company developing novel therapies for the treatment of central nervous system (CNS) diseases, today announced that Sergio Traversa, Chief Executive Officer of Relmada, will participate in the following upcoming virtual investor conferences:
Jefferies London Healthcare Conference
Date: Thursday, November 19, 2020
Time: 10:50 AM EST/3:50 PM GMT
Webcast: A live webcast of the fireside chat will be available by visiting the "Investors" section of the company's website: HTTP://www.relmada.com. A replay of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.
Piper Sandler 32nd Annual Healthcare Conference
Management will participate in a fireside chat, which will be accessible beginning on November 23, 2020, via the "Investors" section of the company's website: HTTP://www.relmada.com. The link will remain active for 90 days thereafter.
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a late-stage pharmaceutical company addressing diseases of the central nervous system (CNS), with a focus on major depressive disorder (MDD). Our experienced and dedicated team is committed to making a difference in the lives of patients and their families. Relmada' s lead program, REL-1017, is a novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission, and is entering late-stage studies as an adjunctive treatment for MDD in adults.
Investor Contact:
Tim McCarthy
LifeSci Advisors
212-915-2564
mailto://tim@lifesciadvisors.com
Media Inquiries:
FischTank PR
mailto://relmada@fischtankpr.com
View original content to download multimedia: http://www.prnewswire.com/news-releases/relmada-therapeutics-to-participate-in-upcoming-investor-conferences-301174575.html
SOURCE Relmada Therapeutics, Inc.
Paulness
4 years ago
NEWS -- Relmada Therapeutics Expands R&D Team, Appoints Paolo Manfredi, M.D., as Acting Chief Scientific Officer, Marco Pappagallo, M.D., as Acting Chief Medical Officer and Updates R&D Milestones
NEW YORK, Oct. 27, 2020 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a clinical-stage company developing novel therapies for the treatment of central nervous system (CNS) diseases, today announced the expansion of its leadership team with the appointments of Paolo Manfredi, M.D., as Acting Chief Scientific Officer and Marco Pappagallo, M.D., as Acting Chief Medical Officer. The Company also provided an update of upcoming milestones for the REL-1017 program.
Dr. Manfredi has been the co-founder of Medeor, Inc. (now merged into Relmada), for which he also served as Scientific Director and co-inventor of REL-1017. Prior to this, Dr. Manfredi was an Assistant Professor in Neurology and Neuroscience at the Weill Medical College of Cornell University and served as the Fellowship Director of the Pain and Palliative Care Program at Memorial Sloan Kettering Cancer Center. Dr. Manfredi earned his Doctor of Medicine at the University of Genoa, Italy, completed his residency in neurology at Albert Einstein College of Medicine and completed several postdoctoral training fellowships, including a pain management fellowship at Massachusetts General Hospital and Harvard University.
Dr. Pappagallo most recently served as Chief Medical Officer at CerSci Therapeutics, a privately-held biotech company focused on developing pain therapeutics that was recently acquired by ACADIA Pharmaceuticals. Prior to this, he held the role of Medical Expert-in-Residence and Executive Director of Medical Intelligence at Grünenthal - USA. Dr. Pappagallo previously served as the co-founder and Chief Medical Officer of NovaPharm Therapeutics. Dr. Pappagallo served in a number of senior roles at leading medical institutions, including as the Director of Chronic Pain in the Department of Pain and Palliative Care at Beth Israel Medical Center and Professor and Director of Pain Research in the Department of Anesthesiology at Mount Sinai Medical Center. Dr. Pappagallo completed his medical school and post-graduate training in neurosurgery at the University of Rome, Italy. Subsequently, he completed his neurology residency training at the State University of New York at Stony Brook and was a clinical and research fellow in pain medicine at John Hopkins University.
Relmada also provided an R&D milestone update, as the company continues to be on track to start its first pivotal Phase III trial of REL-1017 for the adjunctive treatment of major depressive disorder (MDD) in the fourth quarter of 2020. Also, this quarter, the company expects to begin its human abuse potential studies of REL-1017. Other anticipated milestones for REL-1017 in 2021 include:1H21 – Start of second pivotal Phase III adjunctive MDD trial1H21 – Start of Phase II monotherapy MDD trial2Q21 – Results of human abuse potential studies4Q21 – Results of Phase II monotherapy MDD trial1H22 – Results of Phase III adjunctive MDD trials"We are delighted to welcome Dr. Manfredi and Dr. Pappagallo to Relmada' s leadership team. Dr. Manfredi was the co-founder of Medeor, Inc., now merged into Relmada. As a co-inventor of our core technology, Dr. Manfredi's deep insight and expertise will continue to be invaluable in the further clinical development of our lead product candidate, REL-1017," said Sergio Traversa, Chief Executive Officer of Relmada. "Dr. Pappagallo brings over 30 years of medical expertise in neurology medicine. With his significant experience directing clinical programs and passion for addressing significant medical unmet needs, Dr. Pappagallo will be instrumental in shaping Relmada' s future clinical development strategy and execution. We look forward to the significant contributions of both of these world-renowned medical experts. We are also quite excited to provide our milestone update, which highlights our team's robust progress, as we continue to advance REL-1017's late-stage development."
"I am delighted to expand my commitment to Relmada to oversee its research programs as Acting Chief Scientific Officer and lead the scientific development of REL-1017, a compound with which I am extremely familiar and I look forward to advancing this innovative treatment," said Dr. Manfredi.
Dr. Pappagallo commented, "I am excited about joining a team focused on addressing diseases of the CNS with innovative approaches, and most importantly to help the millions of people who continue to need new options for the treatment of MDD. I look forward to leading the next and last phase of clinical development of REL-1017, as an adjunctive as well as front line monotherapy treatment of MDD, as we progress our development program."
About REL-1017
REL-1017, a novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission, is entering late-stage studies as an adjunctive treatment for MDD in adults. In addition to safety and efficacy, our clinical program for REL-1017 will evaluate its potential as the first rapid-acting, oral, once-daily antidepressant treatment. In a Phase 2 trial, REL-1017 demonstrated rapid onset and sustained antidepressant effects with statistically significant improvements as compared to placebo on efficacy measures. The Phase 2 study also confirmed the favorable safety and tolerability profile of REL-1017 observed in previously completed Phase 1 studies. In April 2017, the FDA granted Fast Track designation for REL-1017 for the adjunctive treatment of major depressive disorder.
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a late-stage pharmaceutical company addressing diseases of the central nervous system (CNS), with a focus on major depressive disorder (MDD). Our experienced and dedicated team is committed to making a difference in the lives of patients and their families. Relmada' s lead program, REL-1017, is a novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission, and is entering late-stage studies as an adjunctive treatment for MDD in adults.
Forward-Looking Statements
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding the expected use of the proceeds from the offering. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as "expects," "anticipates," "believes," "will," "will likely result," "will continue," "plans to," "potential," "promising," and similar expressions. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including the risk factors described under the heading "Risk Factors" set forth in the Company's reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be a complete list.
Investor Contact:
Tim McCarthy
LifeSci Advisors
212-915-2564
mailto://tim@lifesciadvisors.com
Media Inquiries:
FischTank PR
mailto://relmada@fischtankpr.com
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SOURCE Relmada Therapeutics, Inc.
Paulness
4 years ago
NEWS -- Relmada Therapeutics Announces Uplisting to the Nasdaq Global Select Market®
NEW YORK, July 13, 2020 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a clinical-stage company developing novel therapies for the treatment of central nervous system (CNS) diseases, announced that effective as of market open on July 14, 2020, its common stock has been approved for uplisting to the Nasdaq Global Select Market® and will continue trading under its current ticker symbol "RLMD."
The Nasdaq Global Select Market® is a mark of achievement and stature for qualified companies. Listed companies must meet financial and liquidity requirements and satisfy corporate governance and disclosure requirements on both an initial and continuing basis.
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a clinical-stage, publicly traded biotechnology company developing novel medicines to address areas of high unmet medical need in the treatment of central nervous system (CNS) diseases. Relmada's lead program, REL-1017 (dextromethadone) is an N-methyl-D-aspartate (NMDA) receptor antagonist in development for the treatment of depression. NMDA receptor antagonists may have utility in the treatment of a range of psychiatric and neurological disorders associated with a variety of cognitive, neurological and behavioral symptoms.
Investor Contact:
Tim McCarthy
LifeSci Advisors
212-915-2564
mailto://tim@lifesciadvisors.com
For Media Inquiries:
FischTank PR
mailto://relmada@fischtankpr.com
View original content to download multimedia: http://www.prnewswire.com/news-releases/relmada-therapeutics-announces-uplisting-to-the-nasdaq-global-select-market-301092149.html
SOURCE Relmada Therapeutics, Inc.
Paulness
4 years ago
NEWS -- Relmada Therapeutics Announces Notice of Allowance for Patent in Canada Covering REL-1017 for Treatment of Psychiatric Symptoms
Patent Further Expands Company's Intellectual Property Protection for REL-1017 a Novel NMDA Receptor Antagonist, in a Major Global Market
NEW YORK , June 23, 2020 /CNW/ -- Relmada Therapeutics, Inc. (RLMD), a clinical-stage company developing novel therapies for the treatment of central nervous system (CNS) diseases, today announced the receipt of a Notice of Allowance from the Canadian Intellectual Property Office for Relmada's patent application number, 2,893,238, titled, "d-Methadone for the Treatment of Psychiatric Symptoms." The patent that will issue from this allowed application provides broad coverage in Canada for REL-1017 (d-methadone, dextromethadone,), a novel N-methyl-D-aspartate (NMDA) receptor antagonist, for the treatment of symptoms associated with a wide range of psychological and psychiatric disorders, including depression, anxiety, fatigue, and mood instability.
"This patent, which has previously been granted in the U.S., EU, Australia , China , Hong Kong , Mexico , and South Korea , advances our objective of further strengthening our intellectual property portfolio in multiple key markets around the world," said Sergio Traversa , CEO of Relmada Therapeutics. " Canada represents a significant market opportunity for Relmada, as published research indicates that the 12 months' prevalence rate of major depressive disorder (MDD) in Canada was 4.7%, and the lifetime prevalence rate was 11.2%¹. We look forward to initiating our Phase 3 program for REL-1017 for the adjunctive treatment of MDD in the fourth quarter of this year."
Relmada recently completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on its development program of REL-1017 for the adjunctive treatment of MDD patients. Based on the FDA feedback, the Company can proceed into Phase 3 without conducting additional clinical studies, and the FDA and Relmada are aligned on all key aspects of the planned Phase 3 program.
About REL-1017 (dextromethadone)
REL-1017 is a non-competitive N-methyl-D-aspartate Receptor (NMDAR) antagonist with the potential to be the first oral single agent NMDAR antagonist approved for the adjunctive treatment of MDD. In a Phase 2 trial, REL-1017 demonstrated rapid onset and sustained antidepressant effects with statistically significant improvements as compared to placebo on efficacy measures. The Phase 2 study also confirmed the favorable safety and tolerability profile of REL-1017 observed in previously completed Phase 1 studies. In April 2017 , the FDA granted Fast Track designation for dextromethadone for the adjunctive treatment of major depressive disorder.
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a clinical-stage, publicly traded biotechnology company developing novel medicines to address areas of high unmet medical need in the treatment of central nervous system (CNS) diseases. Relmada's lead program, REL-1017 (dextromethadone) is an N-methyl-D-aspartate (NMDA) receptor antagonist in development for the treatment of depression. NMDA receptor antagonists may have utility in the treatment of a range of psychiatric and neurological disorders associated with a variety of cognitive, neurological and behavioral symptoms.
Forward-Looking Statements
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding the expected use of the proceeds from the offering. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as "expects," "anticipates," "believes," "will," "will likely result," "will continue," "plans to," "potential," "promising," and similar expressions. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including the risk factors described under the heading "Risk Factors" set forth in the Company's reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be a complete list.
Investor Contact:
Tim McCarthy
LifeSci Advisors
212-915-2564
mailto://tim@lifesciadvisors.com
For Media Inquiries:
FischTank PR
mailto://relmada@fischtankpr.com
¹ Knoll, A. D., & MacLennan, R. N. (2017). Prevalence and correlates of depression in Canada : Findings from the Canadian Community Health Survey. Canadian Psychology/Psychologie Canadienne, 58(2), 116–123.
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SOURCE Relmada Therapeutics, Inc.
Biobonic
5 years ago
Notes from recent presentations
In the GS event the question was asked about how do Phase 2 results get duplicated in the critical Phase 3 trials.
Sergio Traversa answers: Good question, can distill it down to two reasons why there is a depression trial fail,
one is the patient selection
and the other is the placebo effect
Why Relmada did well in Phase 2:
First half of test was in clinic, good control of placebo
Relmada uses two diagnostic tools in patient selection:
one is the SAFER test
Link to Safer pdf which helps to reduce the effect of having patients who are not really depressed but may have other CNS disorders.
Placebo effect is actually higher in clinic settings than in outside (at home) settings.
Upon the hiring of Marc de Somer MD, MBA, ScD, MPH, MSc, as Senior Vice President, Clinical Development and Safety...
he outlined his goals at Relmada...
"I am very excited to focus on maximizing our probability of success, defeating placebo response and excessive noise to demonstrate the true therapeutic signal with the necessary accuracy, precision and replicability. I look forward to working with the Relmada team, as we effectively conduct clinical trials to provide the highest quality of information and therapeutic value for patients, prescribers, payers and shareholders." said Dr. de Somer. "I look forward to contributing to de-risking development of REL-1017 in MDD, and additional indications and programs, as we build our pipeline and team."
Paulness
5 years ago
NEWS -- Relmada Therapeutics to Present at the Goldman Sachs 41st Annual Global Healthcare Conference
NEW YORK, June 9, 2020 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a clinical-stage company developing novel therapies for the treatment of central nervous system (CNS) diseases, today announced that Sergio Traversa, Chief Executive Officer of Relmada, will participate in a fireside chat at the Goldman Sachs 41st Annual Global Healthcare Conference, being held June 9-11, 2020.
Fireside Chat Details:Date: Thursday, June 11, 2020Time: 3:00 PM EDTWebcast: A live webcast of the fireside chat will be available by visiting the "Investors" section of the company's website: http://www.relmada.com. A replay of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.About Relmada Therapeutics, Inc.
Relmada Therapeutics is a clinical-stage, publicly traded biotechnology company developing novel medicines to address areas of high unmet medical need in the treatment of central nervous system (CNS) diseases. Relmada's lead program, REL-1017 (dextromethadone) is an N-methyl-D-aspartate (NMDA) receptor antagonist in development for the treatment of depression. NMDA receptor antagonists may have utility in the treatment of a range of psychiatric and neurological disorders associated with a variety of cognitive, neurological and behavioral symptoms.
Investor Contact:
Tim McCarthy
LifeSci Advisors
212-915-2564
mailto://tim@lifesciadvisors.com
For Media Inquiries:
FischTank PR
mailto://relmada@fischtankpr.com
View original content to download multimedia: http://www.prnewswire.com/news-releases/relmada-therapeutics-to-present-at-the-goldman-sachs-41st-annual-global-healthcare-conference-301072754.html
SOURCE Relmada Therapeutics, Inc.
Paulness
5 years ago
NEWS -- Relmada Therapeutics Enhances Senior Leadership Team with Appointment of Brian A. Walter, Ph.D., as Vice President of Regulatory Affairs
NEW YORK, April 28, 2020 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a clinical-stage company developing novel therapies for the treatment of central nervous system (CNS) diseases, today announced the appointment of Brian A. Walter, Ph.D., as Vice President of Regulatory Affairs. Dr. Walter will provide oversight for all U.S. and international regulatory strategy and operations. He has more than 30 years of experience in the biopharmaceutical industry, including 20 years in global regulatory affairs leading small molecule products and biologics, including antibodies and gene therapies, through the regulatory process from early development to approval.
Dr. Walter joins Relmada from REGENXBIO Inc., where he most recently served as Vice President of Regulatory Affairs, responsible for the global regulatory strategy, operations, pharmacovigilance, and medical writing for the company's portfolio of AAV-based gene therapy development candidates. Previously, from 2014 to 2018, Dr. Walter was Executive Director of Regulatory Affairs at Regeneron Pharmaceuticals, where he led and managed the regulatory affair liaison group for metabolic & endocrine, infectious diseases, immunology, drug-device combinations, and companion diagnostics for development and marketed products. From 2006 to 2014, Dr. Walter was Vice President, Regulatory Affairs, for Acorda Therapeutics, where he established and led the regulatory affairs department from pre-IPO to approval of the company's first marketed product. From 1994 to 2006, Dr. Walter served in multiple roles at Boehringer Ingelheim Pharmaceuticals, most recently as Senior Associate Director, Drug Regulatory Affairs, Cardiovascular, CNS and General Drugs Section. From 1989 to 1994, he was Group Head, Human Metabolism, Clinical Pharmacokinetics and Disposition Department, at CIBA-GEIGY Corporation. From 1988 to 1989, Dr. Walter was a chemist in the Biochemistry Department of BAYER Corporation, Agricultural division.
Dr. Walter earned his B.S. in biology from Denison University in Granville, Ohio, and his Ph.D. in toxicology and drug metabolism from the University of Kentucky College of Pharmacy.
"I am delighted to join the Relmada R&D team and look forward to advance REL-1017, an orally delivered anti-depressant with a potentially unique rapid-onset of action and sustained antidepressant effect for the treatment of patients with a major depressive disorder. REL-1071 has been designated by FDA as a Fast-Track drug, and, if approved, will fulfill an unmet medical need for patients with a serious condition," said Dr. Walter. "It is an exciting time for the Company, and I look forward to working with the Relmada team to develop regulatory strategies to advance this innovative treatment for patients and their families."
"Dr. Walter has an impressive track record in regulatory affairs. We are thrilled to have Brian join the growing Relmada R&D team at this juncture, as we plan for our phase 3 program of REL-1017 and consider regulatory strategies in the EU, Japan and the rest of the world," said Thomas Wessel, Head of Research and Development at Relmada.
"Brian is a highly experienced regulatory affairs professional," said Sergio Traversa, Chief Executive Officer of Relmada. "He has led the interactions with regulatory agencies globally around a multitude of development and marketed products. We look forward to leveraging Brian's broad expertise as we discuss the planning of our pivotal Phase 3 program of REL-1017 as an adjunctive treatment in patients with major depression with the U.S. Food and Drug Administration and other regulatory agencies around the world."
About dextromethadone (REL-1017)
Relmada is currently developing dextromethadone as a rapidly acting oral agent for the treatment of depression. Working as an NMDA receptor antagonist and on the same binding site as ketamine but having shown no ketamine psychotomimetics side effects, dextromethadone is fundamentally differentiated from all currently FDA-approved antidepressants, as well as all atypical antipsychotics used adjunctively. In April 2017, the FDA granted Fast Track designation for dextromethadone for the adjunctive treatment of major depressive disorder.
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a clinical-stage, publicly traded biotechnology company developing novel medicines to address areas of high unmet medical need in the treatment of central nervous system (CNS) diseases. Relmada's lead program, dextromethadone (REL-1017), is an N-methyl-D-aspartate (NMDA) receptor antagonist in development for the treatment of depression. NMDA receptor antagonists may have utility in the treatment of a range of psychiatric and neurological disorders associated with a variety of cognitive, neurological and behavioral symptoms.
Forward-Looking Statements
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding the expected use of the proceeds from the offering. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as "expects," "anticipates," "believes," "will," "will likely result," "will continue," "plans to" and similar expressions. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including the risk factors described under the heading "Risk Factors" set forth in the Company's reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be a complete list.
Investor Contact:
Tim McCarthy
LifeSci Advisors
212-915-2564
mailto://tim@lifesciadvisors.com
For Media Inquiries:
FischTank Marketing and PR
mailto://relmada@fischtankpr.com
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SOURCE Relmada Therapeutics, Inc.
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