DermBiont, a clinical-stage biotech company specializing in innovative topical treatments for rare oncology and dermatology conditions, has reported promising initial results from its open-label, multi-center Phase 2a trial for basal cell carcinoma (BCC). Following these positive findings, DermBiont is shifting its focus to prioritize SM-020, a pioneering topical kinase inhibitor, for two key orphan disease indications: treating locally advanced basal cell carcinoma (laBCC) and preventing BCC in patients with Gorlin Syndrome.
DermBiont’s Phase 2a open-label trial is currently enrolling up to 30 participants with superficial, nodular, or infiltrating primary basal cell carcinomas (BCCs). Patients are treated with SM-020 1% gel twice daily for 28 days. The primary endpoint is the change in tumor diameter from baseline at week 6, with safety assessed through adverse events and application site reactions.
So far, seven patients with nine BCCs (1 superficial, 4 nodular, 4 infiltrating) have shown a rapid and significant clinical response to SM-020, with all tumors demonstrating partial or total reduction. Dr. Karl Beutner, CEO of DermBiont, expressed enthusiasm about these early results, highlighting the potential benefits of SM-020 as a topical alternative to oral hedgehog inhibitors and surgical procedures for patients with locally advanced BCC (laBCC) and Gorlin Syndrome.
SM-020 has been well tolerated with no drug-related adverse events and only mild-to-moderate application site reactions. It has also shown high tolerability in previous trials for seborrheic keratoses. Dr. Emma Taylor, CMO at DermBiont, noted that SM-020’s robust clinical response aligns with its potent in vitro activity against BCC cells.
BCC is the most common cancer in the U.S., with over three million cases annually. DermBiont plans to seek Orphan Drug and Fast Track Designations for SM-020 for treating laBCC and preventing BCC in Gorlin Syndrome patients, and will pursue pivotal trials for these indications. The company is also evaluating the future of its SK program.
DermBiont is advancing innovative topical treatments for rare oncology and dermatology conditions, including SM-020 for BCC and SM-030 for melasma and other hyperpigmentation disorders.
