— On track to initiate Phase 2b trial in Q1 2023; Main data expected in Q1 2024 —
— Received remaining investment of $25 million in previously announced private placement financing —
ARLINGTON, Mass., Dec. Feb. 27, 2022 (GLOBE NEWSWIRE) — Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for rare eye diseases, has 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 (MSC) secretome -S), initially in development for the treatment of persistent corneal epithelial defect (PCED).
“The acceptance of IND KPI-012 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 focusing on clinical execution. We are working closely with researchers to initiate our Phase 2b clinical trial of KPI-012 for PCED in Q1 2023.”
The Phase 2b clinical trial will be a multicenter, randomized, double-blind, vehicle-controlled, parallel-group study to evaluate the safety and efficacy of two doses of KPI-012 Ophthalmic Solution versus vehicle when is administered topically four times a 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 cure of PCED, as measured by corneal fluorescein staining. Kala expects to initiate trial enrollment in Q1 2023 and expects to report key data in Q1 2024. If results are positive, Kala believes this trial could serve as the first of two pivotal trials needed to support the submission of a Biologics License Application (BLA) to the FDA.
Additionally, following the FDA’s acceptance of the IND application for KPI-012 and the terms of the private placement announced on November 28, 2022, Kala today sold a total of 43,478 Series E non-redeemable convertible preferred shares at a price of $575.00 per share to a life sciences-focused investor for gross proceeds of $25.0 million . In total, Kala has raised aggregate gross proceeds of $31.0 million from the private placement.
About KPI-012 for Persistent Corneal Epithelial Defect (PCED)
Persistent corneal epithelial defect, which is defined as a persistent corneal defect or wound that does not heal and is refractory to conventional treatments, is a rare condition 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, mechanical and chemical trauma and, if untreated , can lead to infection, ulceration or perforation of the cornea, scarring, clouding .and significant loss of vision.
Based on its multifactorial mechanism of action and the preclinical and clinical data generated to date, Kala believes that KPI-012 may represent a significant advance in the treatment of PCED and could become the first approved treatment for PCED in all its different etiologies.
About Kala Pharmaceuticals, Inc.
Kala is a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare eye diseases. Kala’s investigational biologics-based 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 many human-derived biofactors, such as growth factors, protease inhibitors, matrix proteins and neurotrophic factors that can potentially correct impaired corneal healing which is an underlying etiology of multiple severe eye diseases. KPI-012 is currently in clinical development for the treatment of persistent corneal epithelial defect (PCED), a rare disorder of impaired corneal wound healing, for which it has received orphan drug designation from the United States 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 disease and plans to initiate preclinical studies to assess the potential utility of its MSC- S for retinal degeneration diseases. For more information about 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 contained in this press release regarding Kala’s future expectations, plans and prospects, including but not limited to statements regarding Kala’s expectations regarding the potential benefits of KPI-012 and its MSC- S; expected timelines to initiate the KPI-012 Phase 2b clinical trial and report key data; the design of the phase 2b clinical trial; clinical utility of KPI-012 for PCED; plans to continue 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”, “probable”, “will”, “could”, “should”, ” continue” and similar expressions constitute forward-looking expressions. statements. Actual results may differ materially from those indicated by these forward-looking statements due to various important factors, including: Kala’s ability to meet the covenants of its current loan agreement; The uncertainties inherent in the initiation and conduct of preclinical studies and clinical trials; Uncertainties regarding the availability and timing of clinical trial data; Whether the results of early clinical trials or trials with different disease indications will be indicative of the results of ongoing or future trials; Whether the results of the KPI-012 Phase 1b clinical trial will be indicative of the results of 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 marketing authorization applications; 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 the need for additional financing and other important factors, each 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 the Kala’s annual report on Form 10-K, the most recently filed quarterly report on Form 10-Q and other documents filed by Kala with the Securities and Exchange Commission. These forward-looking statements represent the views of Kala as of the date of this press release and should not be relied upon as representing the views of Kala as of any date subsequent to the date hereof. Kala undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Investor contacts:
Hannah Deresiewicz
hannah.deresiewicz@sternir.com
212-362-1200
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