Kala Pharmaceuticals Announces FDA Acceptance of IND Application for KPI-012 for the Treatment of PCED
December 27 2022 - 4:01PM
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 that the U.S. Food and Drug Administration
(FDA) has accepted an investigational new drug (IND) application
for the company’s lead product candidate, KPI-012, a human
mesenchymal stem cell secretome (MSC-S), initially in development
for the treatment of persistent corneal epithelial defect (PCED).
“The acceptance of the KPI-012 IND is an important milestone for
Kala, as we work to translate the promise of our MSC-S platform
into better outcomes for people living with rare ocular surface
diseases,” said Kim Brazzell, Ph.D., Head of R&D and Chief
Medical Officer of Kala Pharmaceuticals. “We are now turning our
focus to clinical execution. We are working closely with
investigators to initiate our Phase 2b clinical trial of KPI-012
for PCED in the first quarter of 2023.”
The Phase 2b clinical trial will be a multicenter, randomized,
double-masked, vehicle-controlled, parallel-group study to evaluate
the safety and efficacy of two doses of KPI-012 ophthalmic solution
compared to vehicle when dosed topically four times per day (QID)
for 56 days. The trial is expected to enroll approximately 90 adult
patients with PCED, and the primary endpoint of the trial will be
complete healing of the PCED as measured by corneal fluorescein
staining. Kala expects to initiate enrollment in the trial in the
first quarter of 2023 and expects to report topline data in the
first quarter of 2024. If the results are positive, Kala believes
this trial could serve as the first of two pivotal trials required
to support the submission of a Biologics License Application (BLA)
to the FDA.
In addition, following the FDA’s acceptance of the IND
application for KPI-012 and under the terms of the private
placement announced on November 28, 2022, Kala today sold an
aggregate of 43,478 shares of Series E Convertible Non-Redeemable
Preferred Stock at a price of $575.00 per share to a life sciences
focused-investor for gross proceeds of $25.0 million. In total,
Kala raised aggregate gross proceeds of $31.0 million in the
private placement.
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.
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; anticipated timelines to initiate the Phase 2b clinical
trial of KPI-012 and report topline data; the design of the Phase
2b clinical trial; 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 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: Kala’s ability to comply with the covenants
under its outstanding loan agreement; 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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