Kala Pharmaceuticals Announces Positive Safety Update from Cohort 1 of CHASE Phase 2b Clinical Trial Evaluating KPI-012 in Patients with PCED
March 27 2023 - 7:00AM
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 positive safety data from the
first cohort of the CHASE (
Corneal
Healing
After
SEcretome therapy) Phase 2b clinical trial
evaluating KPI-012, a human mesenchymal stem cell secretome
(MCS-S), for the treatment of persistent corneal epithelial defect
(PCED). The first cohort enrolled two patients, treated with a high
dose of KPI-012 (3 U/mL) four times per day (QID). Both patients
successfully completed at least one week of dosing with no safety
issues observed. The trial will now advance to Cohort 2.
The CHASE trial includes two patient cohorts. The first cohort
is an open-label study to evaluate the safety of the high dose of
KPI-012 (3 U/mL) dosed topically QID in two patients. The second
cohort is a multicenter, randomized, double-masked,
vehicle-controlled, parallel-group study to evaluate the safety and
tolerability of two doses of KPI-012 ophthalmic solution (3 U/mL
and 1 U/mL) versus vehicle dosed topically QID for 56 days in
approximately 90 patients. The primary endpoint of the trial is the
complete healing of the PCED as measured by corneal fluorescein
staining. Kala is targeting reporting topline safety and efficacy
data in the first quarter of 2024. If the results are positive, and
subject to discussion with regulatory authorities, 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 U.S. Food and Drug Administration.
“We are encouraged by the early safety data from the CHASE Phase
2b trial. Generating positive safety data at the high dose and
moving to Cohort 2 represents a significant milestone for our
KPI-012 development program. Based on these results, we are moving
quickly to initiate the second patient cohort,” said Kim Brazzell,
Ph.D., Head of R&D and Chief Medical Officer of Kala
Pharmaceuticals. “We believe the multifactorial mechanism of action
of KPI-012 can address impaired corneal healing at multiple points
in the healing process, potentially enabling us to provide the
first therapy to address all underlying etiologies of PCED. We
believe KPI-012 could fill a large unmet need in this rare disease
and look forward to the continued development of KPI-012 for the
estimated 100,000 people annually suffering from PCED in the United
States and the thousands of other PCED patients around the
world.”
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 Limbal
Stem Cell Deficiency and ocular manifestations of
moderate-to-severe Sjögren's and has initiated preclinical studies
to evaluate the potential utility of its MSC-S platform for
inherited 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; anticipated timelines to report topline data
for the CHASE Phase 2b clinical trial of KPI-012; the potential
regulatory pathway for KPI-012; the design of the CHASE 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:
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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