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Kala’s acquisition of Combangio expands its clinical-stage biologic pipeline.
Kala Pharmaceuticals, a biopharmaceutical company focused on eye disease therapies, announced on Nov. 15, 2021 that it had acquired Combangio, a clinical-stage company developing regenerative biotherapies for severe ocular surface diseases. This approximately $16 million acquisition adds CMB-012 (now known as KPI-012), a novel investigational secretome therapy, to Kala’s pipeline.
KPI-012 is intended to treat persistent corneal epithelial defect (PCED), a condition characterized by persistent non-healing corneal defects or wounds that are resistant to conventional treatments, and other ocular diseases of a similar nature. According to a company press release, PCED is a rare disease with an estimated 238,000 cases in the United States, European Union, and Japan combined. As a result, KPI-012 received orphan drug designation from FDA for the treatment of PCED.
In a Phase 1b clinical trial in which seven of eight PCED patients were treated with KPI-012 twice-daily, seven of eight PCED patients showed improvement in their PCED, and six of eight achieved complete healing over the course of the treatment period (one to eight weeks). Four patients were completely healed within a week of beginning treatment, while two healed within two-to-four weeks. According to the press release, it was well-tolerated with no treatment-related safety issues observed. Kala plans to submit an investigational new drug application to FDA and initiate a Phase II/III trial of KPI-012 in the third quarter of 2022.
“Today’s acquisition marks a pivotal moment for Kala and a meaningful acceleration toward our goal of strengthening Kala’s pipeline for the treatment of front and back of the eye diseases,” said Mark Iwicki, CEO of Kala, in the press release. “[KPI-012] is a natural fit with our R&D and commercial expertise, and along with our internal pipeline provides an additional opportunity to leverage our deep ophthalmic expertise to address substantial, underserved markets. We are excited to have completed the acquisition of Combangio and look forward to working alongside their talented team to integrate KPI-012 into our portfolio and ultimately deliver this therapy to transform the treatment of rare ocular surface diseases.”
Source: Kala Pharmaceuticals