Kala Pharmaceuticals , Inc .KALA announced that the FDA has accepted its investigational new drug (IND) application for its lead product candidate, KPI-012, which is being developed for the treatment of persistent corneal epithelial defect (PCED), a rare disease of impaired corneal healing.
The company plans to begin a phase IIb study evaluating KPI-012 for treating PCED in the first quarter of 2023.The randomized, vehicle-controlled, parallel-group phase IIb study will enroll around 90 adult patients with PCED and is designed to evaluate the safety and efficacy of two doses of KPI-012 ophthalmic solution versus vehicle for 56 days. The primary endpoint of the study will check the complete healing of the PCED as measured by corneal fluorescein staining.
Top-line data from the above-mentioned study is expected in the first quarter of 2024.Per the company, if data from the above-mentioned is found to be positive, this could serve as the first of two pivotal studies required for filing a biologics license application for KPI-012 to the FDA.Shares of Kala Pharmaceuticals were up 33.4% in after-hours trading on Tuesday following the announcement of the news. The stock has plunged 93.3% in the past year compared with the industry’s decline of 22.8%.In November 2022, the company submitted the IND application for KPI-012 to the FDA.Per the terms of the private placement announced last month, Kala Pharmaceuticals sold an aggregate of 43,478 shares of Series E Convertible Non-Redeemable Preferred Stock at $575 per share to a life sciences focused-investor for $25 million following the IND acceptance by the regulatory body.Kala Pharmaceuticals’ lead pipeline candidate, KPI-012 is a human mesenchymal stem cell secretome.
The FDA has already granted an orphan drug designation to KPI-012 for treating PCED. The company is also planning to develop KPI-012 targeting other ocular indications.
Successful development and potential approval for KPI-012 will be a huge boost for the company.
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