DermBiont Announces Treatment of Locally Advanced Basal Cell Carcinoma and Prevention of Basal Cell Carcinoma in Gorlin Syndrome Patients as New Lead Indications for SM-020 Following Positive Initial Phase 2a Data
– 100% of 9 treated BCCs (1 superficial, 4 nodular, and 4 infiltrating) across 7 enrolled subjects to date demonstrate prompt, visible, and robust tumor responses during treatment with SM-020 1% BID for 28 days, resulting in partial or total reduction of clinically visible tumor.
Excerpt from the Press Release:
BOSTON–(BUSINESS WIRE)–DermBiont, a clinical-stage biotechnology company that is advancing first-in-class topical therapeutics to address patient needs in rare disease oncology and aesthetic dermatology, today announced positive initial data from its ongoing open label, multi-center Phase 2a study for the treatment of basal cell carcinoma (BCC). As a result, DermBiont has reprioritized SM-020, a first-in-class, patient-applied, and topical kinase inhibitor, for the development of two lead orphan disease oncology indications: treatment of locally advanced basal cell carcinoma (laBCC) and prevention of BCC in Gorlin Syndrome patients.
DermBiont’s Phase 2a open-label trial is actively enrolling and treating up to 30 subjects with one to five superficial, nodular, or infiltrating primary BCCs. Lesions are being treated with SM-020 1% gel BID (twice daily) for 28 days, with the primary endpoint based on percent change from baseline in greatest tumor diameter at week 6. The safety of the drug product is being evaluated based on frequency of adverse events (AEs) and application site reactions (ASRs).
At the time of this release, seven subjects with a total of nine BCCs (1 superficial, 4 nodular, and 4 infiltrating) have been treated and show a prompt (within days of starting treatment) and robust clinical response to the application of SM-020 1% gel, clearly demonstrating the disease modifying potential of SM-020. All nine tumors have also demonstrated a partial or total reduction in clinically visible tumor.
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