Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a clinical-stage
biopharmaceutical company dedicated to the research, development
and commercialization of innovative therapies for rare and severe
diseases of the eye, today announced the appointment of Francis
Mah, M.D., as Chief Medical Advisor. In this newly established
role, Dr. Mah will provide support for Kala’s clinical development
and medical activities and will play a key role in interactions
with eye care professionals. Dr. Mah will serve in this role on a
part time basis while continuing his ongoing position as Director
of Cornea and External Disease and the Co-Director, Refractive
Surgery at Scripps Clinic.
“We are thrilled to welcome Francis to Kala as our Chief Medical
Advisor. His deep expertise in corneal disease, along with his
strong background in research and his experience serving as
principal investigator on a number of clinical trials, will be
extremely valuable in helping us advance the development of KPI-012
for persistent corneal epithelial defect (PCED) and other rare
diseases,” said Kim Brazzell, Head of R&D and Chief Medical
Officer of Kala Pharmaceuticals. “Earlier this week we were excited
to announce positive safety data from the first cohort of our CHASE
(Corneal Healing
After SEcretome therapy) Phase 2b
clinical trial evaluating KPI-012 for PCED and to share that this
trial is advancing to the second and final cohort. With the CHASE
trial underway, we look forward to collaborating with Francis to
expand our efforts into additional rare diseases of the eye, where
KPI-012’s multifactorial mechanism of action may prove
beneficial.”
“I am very excited about Kala’s innovative mesenchymal stem cell
secretome platform, which I believe can provide a novel solution to
improve the care and treatment of multiple rare and severe ocular
diseases,” said Dr. Mah. “I am particularly excited to partner with
the Kala team to advance KPI-012 for the treatment of PCED. As a
physician, I am acutely aware of the need for new options, which
can safely and effectively facilitate rapid and sustained wound
healing, regardless of the underlying disease etiology. I believe
KPI-012 has the potential to offer a broad-based treatment option
for patients suffering from PCED and look forward to supporting the
company in its execution of the CHASE trial, while also exploring
opportunities to expand KPI-012 for the treatment of additional
rare ocular diseases.”
Dr. Mah brings over 20 years of clinical practice as a
board-certified ophthalmologist and is an esteemed educator who has
disseminated his expertise through more than 80 peer-reviewed
papers and various book chapters on his research and has delivered
presentations in more than 20 countries on 6 continents. Dr. Mah
specializes in advanced corneal, cataract and refractive surgery,
and is currently the Director of Cornea and External Disease and
the Co-Director, Refractive Surgery at Scripps Clinic Medical Group
in La Jolla, CA. He received his B.A. from Dartmouth College, his
M.D. from the Medical College of Ohio at Toledo and completed a
residency in ophthalmology and a fellowship in cornea and
refractive surgery at the University of Pittsburgh.
Dr. Mah has an extensive background in translational research
and has been a principal investigator for many clinical trials and
investigator-initiated studies. Dr. Mah is past Chair of the
Corneal Clinical Committee, current committee member on the FDA
Committee, and a member of the Executive Committee of the American
Society of Cataract and Refractive Surgery. He is also Co-Chair of
the Preferred Practice Patterns for Cornea and External Disease,
and member of the cornea section of the Basic and Clinical Science
Course for the American Academy of Ophthalmology.
About KPI-012 for Persistent Corneal Epithelial Defect
(PCED)
Persistent corneal epithelial defect, which is defined as a
persistent non-healing corneal defect or wound that is refractory
to conventional treatments, is a rare disease with an estimated
incidence in the United States of 100,000 cases per year and
238,000 cases per year in the United States, European Union and
Japan combined. PCED can have various etiologies, including
neurotrophic keratitis, surgical epithelial debridement,
microbial/viral keratitis, corneal transplant, limbal stem cell
deficiency and mechanical and chemical trauma and, if left
untreated, can lead to infection, corneal ulceration or
perforation, scarring, opacification and significant vision
loss.
Based on its multifactorial mechanism of action and preclinical
and clinical data generated to-date, Kala believes KPI-012 may
represent a significant advancement in the treatment of PCED and
could become the first approved treatment for PCED across all its
various etiologies.
About Kala Pharmaceuticals, Inc.
Kala is a clinical-stage biopharmaceutical company dedicated to
the research, development and commercialization of innovative
therapies for rare and severe diseases of the eye. Kala’s
biologics-based investigational therapies utilize Kala’s
proprietary mesenchymal stem cell secretome (MSC-S) platform.
Kala’s lead product candidate, KPI-012, is a human MSC-S, which
contains numerous human-derived biofactors, such as growth factors,
protease inhibitors, matrix proteins and neurotrophic factors that
can potentially correct the impaired corneal healing that is an
underlying etiology of multiple severe ocular diseases. KPI-012 is
currently in clinical development for the treatment of persistent
corneal epithelial defect (PCED), a rare disease of impaired
corneal healing, for which it has received orphan drug designation
from the U.S. Food and Drug Administration. Kala is also targeting
the potential development of KPI-012 for the treatment of Partial
Limbal Stem Cell Deficiency and ocular manifestations of
moderate-to-severe Sjögren's and plans to initiate preclinical
studies to evaluate the potential utility of its MSC-S platform for
retinal degenerative diseases, such as Retinitis Pigmentosa and
Stargardt Disease. For more information on Kala, please
visit www.kalarx.com.
Forward Looking Statements:
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that involve substantial risks and uncertainties. Any statements in
this press release about Kala’s future expectations, plans and
prospects, including but not limited to statements about Kala’s
expectations with respect to potential advantages of KPI-012 and
its MSC-S platform; the clinical utility of KPI-012 for PCED;
Kala’s plans to pursue research and development of KPI-012 and its
MSC-S platform for other indications; and other statements
containing the words “anticipate,” “believe,” “estimate,” “expect,”
“intend,” “may,” “plan,” “predict,” “project,” “target,”
“potential,” “likely,” “will,” “would,” “could,” “should,”
“continue,” and similar expressions constitute forward-looking
statements. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors, including: uncertainties inherent in the
initiation and conduct of preclinical studies and clinical trials;
uncertainties regarding availability and timing of data from
clinical trials; whether results of early clinical trials or trials
in different disease indications will be indicative of the results
of ongoing or future trials; whether results of the Phase 1b
clinical trial of KPI-012 will be indicative of results for any
future clinical trials and studies of KPI-012, including the CHASE
Phase 2b clinical trial; whether interim data from a clinical trial
will be predictive of the results of the trial; uncertainties
associated with regulatory review of clinical trials and
applications for marketing approvals; Kala’s ability to retain and
hire key personnel; the impact of extraordinary external events,
such as the current pandemic health event resulting from the
coronavirus (COVID-19), and their collateral consequences; the
sufficiency of cash resources and need for additional financing and
other important factors, any of which could cause Kala’s actual
results to differ from those contained in the forward-looking
statements, discussed in the “Risk Factors” section of Kala’s
Annual Report on Form 10-K and other filings Kala makes with the
Securities and Exchange Commission. These forward-looking
statements represent Kala’s views as of the date of this press
release and should not be relied upon as representing Kala’s views
as of any date subsequent to the date hereof. Kala does not assume
any obligation to update any forward-looking statements, whether as
a result of new information, future events or otherwise, except as
required by law.
Investor Contact:
Hannah Deresiewiczhannah.deresiewicz@sternir.com
212-362-1200
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