DermBiont Introduces SM-020 for Advanced Basal Cell Carcinoma and Gorlin Syndrome Prevention

BOSTON--DermBiont, a biotechnology company specializing in topical therapeutics for rare diseases in oncology and aesthetic dermatology, has announced promising preliminary results from its ongoing Phase 2a study for treating basal cell carcinoma (BCC). Consequently, DermBiont has shifted its focus to developing SM-020, a patient-applied topical kinase inhibitor, for two primary orphan disease oncology indications: treating locally advanced basal cell carcinoma (laBCC) and preventing BCC in Gorlin Syndrome patients.

The Phase 2a open-label trial is currently enrolling up to 30 participants, each with one to five superficial, nodular, or infiltrating primary BCCs. The treatment involves applying SM-020 1% gel twice daily for 28 days. The primary endpoint is the percentage change in the greatest tumor diameter from baseline at week 6. The safety of the drug is being assessed by monitoring adverse events (AEs) and application site reactions (ASRs).

At the time of the announcement, seven subjects with nine BCCs (comprising one superficial, four nodular, and four infiltrating tumors) had been treated. These subjects demonstrated a rapid and significant clinical response to SM-020 1% gel, indicating the drug's potential for modifying the disease. All treated tumors showed partial or complete reduction in visible size.

Dr. Karl Beutner, M.D., Ph.D., and CEO of DermBiont, expressed enthusiasm over the initial results, emphasizing the potential benefits of a topical treatment for laBCC and BCC prevention in Gorlin Syndrome patients. He highlighted the drawbacks of current oral hedgehog inhibitors, including their side effects, and noted that a topical treatment could offer a more tolerable and less invasive alternative. For Gorlin Syndrome patients, who often undergo costly and painful surgeries to remove chronic BCCs, a topical option could reduce scarring and recovery time.

To date, SM-020 has been well tolerated with no drug-related adverse events and only rare, mostly mild-to-moderate ASRs. Previous clinical trials involving over 100 subjects with seborrheic keratoses (SK) who used the same drug product twice daily for at least 28 days also reported high tolerability.

Dr. Emma Taylor, M.D., Chief Medical Officer at DermBiont, noted the high potency of SM-020 against BCC cells in vitro and its well-defined mechanism of action targeting established tumorigenesis pathways. She stated that the robust clinical response observed was expected based on these properties.

Basal Cell Carcinoma is the most common cancer, with over three million cases annually in the United States. BCCs that are 10mm or larger and unsuitable for conventional treatment are classified as laBCC. In the U.S., over 10,000 people are affected by laBCC each year, with at least another 10,000 suffering from Gorlin Syndrome. Moreover, more than 30,000 individuals experience high frequency sporadic BCC, and tens of thousands are diagnosed with multiple BCCs annually.

DermBiont plans to apply for Orphan Drug and Fast Track Designations for SM-020 to treat laBCC and prevent BCC in Gorlin Syndrome patients. The company aims to follow this with pivotal trials for the approval of SM-020 for these orphan indications. With the reprioritization of SM-020, DermBiont is also exploring options for its SK treatment program.

DermBiont is at the forefront of developing first-in-class topical therapeutics with well-defined mechanisms of action to meet patient needs in rare disease oncology and aesthetic dermatology. Their lead products include SM-020 for laBCC and BCC prevention in Gorlin Syndrome, and SM-030 for treating melasma and other hyperpigmentation disorders.

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