crudeoil24
3 years ago
BELLUS Health Announces Positive Interim Analysis from the Phase 2b SOOTHE Trial of BLU-5937 in Refractory Chronic Cough
7:45 am ET September 13, 2021 (BusinessWire) Print
--Data from interim analysis support accelerated planning for the Phase 3 program
--SOOTHE Phase 2b trial is on track to deliver topline results in Q4 2021
BELLUS Health Inc. (Nasdaq:BLU; TSX:BLU) ("BELLUS Health" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of refractory chronic cough and other hypersensitization-related disorders, today announced positive findings from a preplanned administrative interim analysis of the ongoing Phase 2b SOOTHE trial of BLU-5937, the Company's highly selective P2X3 antagonist, in patients with refractory chronic cough ("RCC").
An independent statistical team reported that the predefined stringent probability threshold for clinical efficacy was met for at least one dose of BLU-5937. The following observations of the interim data were made regarding key aspects of the BLU-5937 product profile:
- At least one dose of BLU-5937 met the stringent predefined probability threshold for a clinically meaningful reduction in placebo-adjusted 24-hour cough frequency;
- Limited taste-related adverse events were observed, consistent with previous BLU-5937 trials;
- No serious adverse events were reported.
"We believe the encouraging SOOTHE Phase 2b trial interim analysis will enable us to accelerate the planning for our Phase 3 program while awaiting SOOTHE final results," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "With trial enrollment progressing as planned, we anticipate announcing topline data in the fourth quarter of 2021."
About SOOTHE
The SOOTHE trial is a multicenter, randomized, double-blind, four-week, parallel arm, placebo-controlled Phase 2b trial evaluating three doses of BLU-5937 (12.5 mg, 50 mg and 200 mg BID) in 300 participants with refractory chronic cough. 240 participants with a baseline awake cough frequency of greater-than or equal to25 awake coughs per hour are expected to be randomized across four arms (1:1:1:1) evaluating the three active doses of BLU-5937 and placebo in the main study. Treatment arms will be stratified to balance the number of participants with baseline awake cough frequency greater-than or equal to45 coughs per hour across trial arms. The primary efficacy endpoint will be the placebo-adjusted change in the 24-hour cough frequency from baseline to day 28 collected with a cough recorder. An exploratory group of an additional 60 participants with a baseline awake cough frequency of greater-than or equal to10 and <25 coughs per hour are expected to be randomized across 2 arms (1:1) evaluating one active dose (200 mg BID) and placebo to further investigate the effect of BLU-5937 in patients with lower cough frequency. More information about the trial is available at www.clinicaltrials.gov: NCT04678206.
About the Interim Analysis
An independent statistical team conducted the preplanned interim analysis once half of the total participants in the main trial completed their treatment period. The interim analysis was performed for administrative purposes and has no impact on the design or future conduct of the SOOTHE trial. Trial participants will continue to be enrolled and followed to trial completion.
About BELLUS Health (www.bellushealth.com)
BELLUS Health is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of RCC and other hypersensitization-related disorders. The Company's product candidate, BLU-5937, is being developed for the treatment of RCC and chronic pruritus associated with AD.
RCC is a cough lasting more than 8 weeks despite appropriate treatment for underlying condition(s). It is estimated that there are approximately 9 million patients in the United States suffering from RCC. RCC is associated with significant adverse physical, social, and psychosocial effects on health and quality of life. Currently, there is no specific therapy approved for RCC and treatment options are limited.
Chronic pruritus associated with AD is an irritating sensation that leads to scratching and persists for longer than 6 weeks in AD patients. It is estimated that up to 10% of adults in the United States suffer from AD - almost all report symptoms of pruritus with over 50% of patients attributing chronic pruritus as their most burdensome symptom. Despite currently available treatments targeting AD, there continues to be a lack of options specifically targeting the burden of pruritus in patients with AD.
richrichrich
3 years ago
I sold my shares on may 18th for a small profit, at 3.72......
Originally bought in 7-14-2020, at 2.90......
So sorry, I haven't looked at it since then.
If it's any consolation, I don't give the ratings agencies(most) much credence at all. Most seem completely wrong on their predictions, in fact you could bet the complete opposite of what they say sometimes, and make profit, using them as a kind of "reverse barometer".....
Good luck.
I-Man
4 years ago
8-K out again.
BELLUS Health Inc. (Nasdaq:BLU; TSX:BLU) ("BELLUS Health" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of refractory chronic cough ("RCC") and other hypersensitization-related disorders, today announced that Roberto Bellini, BELLUS Health's President and Chief Executive Officer, will be participating in a fireside chat at the Jefferies Virtual Healthcare Conference.
Presentation Details:
Event: Jefferies Virtual Healthcare Conference
Date/Time: Tuesday, June 1, 2021 at 10:30 a.m. ET
A live webcast of fireside chat may be accessed on the Events & Presentations page under the Investors & Media section of BELLUS Health's website at www.bellushealth.com. Following the event, an archived webcast will be available on the Company's website.
About BELLUS Health (www.bellushealth.com)
I-Man
4 years ago
BELLUS Health Inc. (Nasdaq:BLU; TSX:BLU) ("BELLUS Health" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of refractory chronic cough ("RCC") and other hypersensitization-related disorders, today announced that three abstracts on BLU-5937 have been accepted for presentation at the upcoming American Thoracic Society ("ATS") 2021 International Conference, being held on May 14-19, 2021.
Mini Symposium Presentation:
Title: Improvements in Cough Frequency Over 24 Hours with BLU-5937, a Selective P2X3 Antagonist, in Patient Subgroups Defined by Baseline Awake Cough Frequencies Session: Hot Takes from Clinical Trials in Lung Disease (A006) Format: Pre-recorded presentation and live discussion period Date: Sunday, May 16 Time: 10:00 - 11:30 a.m. EDT
Poster Presentations:
Title: Design of SOOTHE, a Phase 2b Dose Finding Study with BLU-5937, a Selective P2X3 Antagonist, in Refractory Chronic Cough Session: Assessment and Treatment of Cough and Chronic Dyspnea (TP044) Format: On demand
Title: Baseline Characteristics and Burden of Disease in Populations Defined by Cough Frequency Tiers in RELIEF, a Phase 2 Study on the Efficacy and Safety of BLU-5937 in Refractory Chronic Cough Session: Assessment and Treatment of Cough and Chronic Dyspnea (TP044) Format: On demand
Following the conference, the presentation materials will be available in the "Scientific Publications" section of BELLUS Health's website at www.bellushealth.com.
I-Man
4 years ago
LAVAL, Quebec—April 13, 2021— BELLUS Health Inc. (Nasdaq:BLU; TSX:BLU) (“BELLUS Health” or the “Company”), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of refractory chronic cough and other hypersensitization-related disorders, today announced that Roberto Bellini, BELLUS Health's President and Chief Executive Officer, will present a corporate overview of the Company at the Bloom Burton & Co. Healthcare Investor Conference.
Presentation Details:
Event: Bloom Burton & Co. Healthcare Investor Conference
Date/Time: Tuesday, April 20, 2021 at 2:00 p.m. ET
A live webcast of the presentation may be accessed on the Events & Presentations page under the Investors & Media section of BELLUS Health's website at www.bellushealth.com. Following the event, an archived webcast will be available on the Company’s website.
About BELLUS Health (www.bellushealth.com)
BELLUS Health is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of refractory chronic cough and other hypersensitization-related disorders. The Company's product candidate, BLU-5937, is being developed for the treatment of refractory chronic cough and chronic pruritus associated with atopic dermatitis.
Refractory chronic cough is a cough lasting more than 8 weeks despite appropriate treatment for underlying condition(s). It is estimated that there are approximately 9 million patients in the United States suffering from refractory chronic cough. Refractory chronic cough is associated with significant adverse physical, social, and psychosocial effects on health and quality of life. Currently, there is no specific therapy approved for refractory chronic cough and current treatment options are limited.
Chronic pruritus associated with atopic dermatitis is an irritating sensation that leads to scratching and persists for longer than 6 weeks in atopic dermatitis patients. It is estimated that 5% of adults in the United States suffer from atopic dermatitis – almost all report symptoms of pruritus with over 50% of patients attributing chronic pruritus as their most burdensome symptom. Despite currently available treatments targeting atopic dermatitis, there continues to be a lack of options targeting the burden of pruritus in patients with atopic dermatitis.
FOR MORE INFORMATION, PLEASE CONTACT:
Danny Matthews
Director, Investor Relations and Communications
danny@bellushealth.com
I-Man
4 years ago
6-K Out. Foreign Issuers Report to SEC
These statements reflect current expectations of management regarding future events and operating performance and speak only as of the date of this MD&A. The statements we make regarding the following matters are forward-looking by their nature and are based on certain of the assumptions noted below:
· our aim to develop and commercialize BLU-5937 for the treatment of hypersensitization disorders, including chronic cough and chronic pruritus;
· our aim to complete additional preclinical studies on BLU-5937;
· our aim to complete additional clinical Phase 1 trials with BLU-5937;
2
· our expectations to release topline results in the fourth quarter of 2021 for our Phase 2b SOOTHE clinical trial of BLU-5937 for the treatment of patients with refractory chronic cough and conduct an interim analysis in mid-2021, the results of which we may use to initiate planning activities for Phase 3 clinical trials;
· our expectations to release topline results in the fourth quarter of 2021 for our Phase 2 BLUEPRINT clinical trial of BLU-5937 for the treatment of patients with chronic pruritus associated with atopic dermatitis;
· our aim to further explore the potential of BLU-5937 for the treatment of other afferent hypersensitization-related conditions;
· our expectations with respect to the timing and cost of the research and development activities of BLU-5937;
· the function, potential benefits, tolerability profile, effectiveness and safety of our product candidates, including BLU-5937, including with respect to patient population, pricing and labeling, and the impact of our enrichment strategy on labeling;
· our expectations with respect to pre-commercialization activities related to the commercial launch of BLU-5937;
· our expectations regarding the potential once-daily dosing with extended-release formulation for BLU-5937 and our aim to begin prototype development of the BLU-5937 once-daily formulation in 2021;
· our expectations regarding our ability to arrange for and scale up the manufacturing of BLU-5937 to reach commercial scale;
· our estimates and assessment of the potential markets (including size) for our product candidates;
· our expectations regarding pricing and acceptance of our product candidates by the market;
· our estimates and projections regarding potential pricing for BLU-5937 and how such pricing compares to other P2X3 inhibitors;
· our estimates and projections regarding the size of the total addressable global refractory chronic cough market and associated P2X3 revenue potential;
· the benefits and risks of our product candidates as compared to others;
· our aim to obtain regulatory approvals to market our product candidates;
· our expectations with respect to the cost of preclinical studies and clinical trials and commercialization of our product candidates, including BLU-5937;
· our expectation of the continued listing of the common shares on the TSX and Nasdaq;
· our current and future capital requirements and anticipated sources of financing or revenue;
· our expectations regarding the COVID-19 pandemic and its impact on our business;
· our expectations regarding the protection of our intellectual property;
· our business strategy; and
· our development and partnership plans and objectives.
The preceding list is not intended to be an exhaustive list of all of our forward-looking statements.
Conclusions, forecasts and projections set out in forward-looking information are based on our current objectives and strategies and on expectations and estimates and other factors and assumptions that we believe to be reasonable at the time applied but may prove to be incorrect. These include, but are not limited to:
· the function, potential benefits, effectiveness and safety of BLU-5937;
· the benefits and risks of our product candidates as compared to others;
3
· the accuracy of our belief that selective P2X3 inhibitors have an improved tolerability profile compared to the most advanced P2X3 receptor inhibitor in development, Merck & Co.’s gefapixant;
· progress, timing and costs related to the development, completion and potential commercialization of our product candidate;
· estimates and projections regarding our industry;
· market acceptance of our product candidate;
· future success of current research and development activities;
· achievement of development and commercial milestones, including forecasted preclinical study and clinical trial milestones within the anticipated timeframe;
· our reliance on third parties to conduct preclinical studies and clinical trials for BLU-5937;
· that the timeline and costs for our preclinical and clinical programs are not incorrectly estimated or affected by unforeseen circumstances;
· the successful development of once daily dosing with extended release formulation for BLU-5937;
· our ability to achieve intended order of market entry of BLU-5937 relative to other P2X3 inhibitors;
· accuracy of our findings of statistically significant interaction between baseline cough frequency and treatment benefit, and realization of the intended benefits of our enrichment strategy;
· accuracy of our estimates and projections regarding potential pricing for BLU-5937, including parity to other P2X3 inhibitors;
· accuracy of our estimates and projections regarding the size of the total addressable global refractory chronic cough market and associated P2X3 revenue potential;
· the capacity of our primary supply chain to produce the required clinical supplies to support a Phase 3 program in refractory chronic cough within the anticipated timeframe;
· absence of interruption or delays in the operations of our suppliers of components or raw materials, contract research organizations or other third parties with whom we engage, whether as a result of disruptions caused by the COVID-19 pandemic or otherwise;
· accuracy of our expectations regarding label indication for BLU-5937 in refractory chronic cough and the potential to expand the use of P2X3 inhibitors on all refractory chronic cough patients;
· absence of material deterioration in general business and economic conditions, including the impact on the economy and financial markets of the COVID-19 pandemic and other health risks;
· the effectiveness of COVID-19 containment efforts, including the implementation of vaccination programs and gradual recovery of global environment and global economic conditions;
· the receipt of regulatory and governmental approvals for research and development projects and timing thereof;
· the availability of tax credits and financing for research and development projects, and the availability of financing on favorable terms;
· our expectations regarding our status as a passive foreign investment company;
· the accuracy of our estimates regarding future financing and capital requirements and expenditures;
· the achievement of our forecasted cash burn rate;
· the sufficiency and validity of our intellectual property rights;
· our ability to secure, maintain and protect our intellectual property rights, and to operate without infringing on the proprietary rights of others or having third parties circumvent the rights owned or licensed by us;
· our ability to source and maintain licenses from third-party owners on acceptable terms and conditions;
· absence of significant changes in Canadian dollar-U.S. dollar and other foreign exchange rates or significant variability in interest rates;
4
· the absence of material changes in market competition and accuracy of our assumptions and projections regarding profile and market dynamic amongst more selective agents;
· our ability to attract and retain skilled staff;
· our ability to maintain ongoing relations with employees and business partners, suppliers and other third parties;
· the accuracy of the market research, third-party industry data and forecasts relied upon by us; and
· the absence of adverse changes in relevant laws or regulations.
I-Man
4 years ago
6-K Out last night...
BELLUS Health is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of chronic cough and other hypersensitization-related disorders. The Company's product candidate, BLU-5937, is being developed for the treatment of chronic cough and chronic pruritus.
Chronic cough, the lead indication for BLU-5937, is a cough lasting more than eight weeks and is associated with significant adverse physical, social and psychosocial effects on health and quality of life. It is estimated that approximately 26 million adults in the United States suffer from chronic cough with approximately 3 million having refractory chronic cough lasting for more than a year and approximately 6 million having refractory chronic cough lasting more than 8 weeks and under one year. There is no specific therapy approved for refractory chronic cough and current treatment options are limited.
Chronic pruritus, the second indication for BLU-5937, is commonly known as chronic itch and is an irritating sensation that leads to scratching and persists for longer than six weeks, which can be debilitating and can significantly impact quality of life. It is a hallmark of many inflammatory skin diseases, including atopic dermatitis (“AD”). It is estimated that AD afflicts approximately 5% of adults in the United States. Despite currently available treatments targeting AD, there continues to be a lack of options targeting the burden of pruritus in AD patients.
Register for Free to get streaming real-time quotes, interactive charts, live options flow, and more.
TheFinalCD
3 years ago
aristotelisonassis
4 years ago
ClayTrader
4 years ago
whytestocks
4 years ago
CBD_Kindaguy
4 years ago
Power of Emouna
4 years ago
Hot Features
Premium
