Kala Pharmaceuticals Announces Submission of Investigational New Drug Application for KPI-012 for the Treatment of Persistent Corneal Epithelial Defect
November 28 2022 - 4:02PM
Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a clinical-stage
biopharmaceutical company dedicated to the research, development
and commercialization of innovative therapies for rare diseases of
the eye, today announced the submission of an investigational new
drug (IND) application to the U.S. Food and Drug Administration
(FDA) for KPI-012 for the treatment of Persistent Corneal
Epithelial Defect (PCED). Subject to acceptance of the IND by the
FDA, Kala remains on-track to initiate a Phase 2b clinical trial of
KPI-012 for PCED in the fourth quarter of 2022. Topline safety and
efficacy data from the trial is expected in the first quarter of
2024. If positive, this trial could serve as the first of two
pivotal trials needed to support the submission of a Biologics
License Agreement (BLA) to the FDA. Following acceptance of the IND
for KPI-012 by the FDA, Kala will receive the second tranche from
the private placement of securities announced earlier today which,
together with current cash on hand, Kala expects will extend its
projected cash runway into the first quarter of 2025.
“We are pleased to announce the submission of the IND for PCED,
which brings us an important step closer to our goal of delivering
the promise of mesenchymal stem cell secretome (MSC-S)-based
therapies to address severe ocular diseases,” said Mark Iwicki,
Chief Executive Officer and Chairman of Kala Pharmaceuticals. “This
accomplishment is well timed with the investment commitment
announced earlier today from a life sciences-focused investor,
which reflects a belief in the power of our MSC-S platform to
address significant unmet needs across a range of rare ophthalmic
diseases and, in particular, the potential for KPI-012 to become
the first approved prescription therapy indicated for PCED patients
with a broad range of underlying etiologies. We look forward to
initiating this trial before year end.”
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.
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. Kala intends to initiate a Phase 2b clinical
trial evaluating the efficacy and safety of two doses of KPI-012 in
PCED patients with a broad range of underlying etiologies in the
fourth quarter of 2022. If positive, this trial could serve as the
first of two pivotal trials needed to support the submission of a
Biologics License Agreement (BLA) to the U.S. Food and Drug
Administration.
About Kala Pharmaceuticals, Inc.Kala is a
clinical-stage biopharmaceutical company dedicated to the research,
development and commercialization of innovative therapies for rare
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. 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 future development or commercialization of KPI-012;
regulatory review of its IND submission; plans to initiate and
timelines of clinical trials; the clinical utility of KPI-012 for
PCED; plans to pursue research and development of KPI-012 and its
MSC-S platform for other indications; expectations with respect to
the expected closings of each tranche of the private placement
announced today and the sufficiency of Kala’s existing cash
resources for the period anticipated 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: whether the conditions for the
closing of each tranche of the private placement announced today
will be satisfied; Kala’s ability to maintain its listing on the
Nasdaq Global Select Market; Kala’s ability to comply with the
covenants under its outstanding loan agreement; the 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 planned Phase 2b clinical 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 novel 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 the 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, most recently filed Quarterly Report on
Form 10-Q 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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