The open-label trial is actively enrolling and treating patients with one to five primary basal cell carcinomas. Credit: Nemes Laszlo / Shutterstock.

DermBiont has reported positive initial data from its Phase IIa clinical trial of SM-020, a topical kinase inhibitor for the treatment of basal cell carcinoma (BCC).

Based on this data, the company reprioritised the development of SM-020 for two orphan disease oncology indications: the treatment of locally advanced BCC (laBCC) and BCC prevention in Gorlin Syndrome patients.

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The open-label trial is actively enrolling and treating patients with one to five primary BCCs, which are being treated with SM-020 1% gel twice daily for 28 days.

The primary endpoint of the study is the percentage change from baseline in the greatest tumour diameter at week six, alongside the evaluation of the safety profile based on adverse events (AEs) and application site reactions (ASRs).

So far, seven patients with a total of nine BCCs have been treated, showing a prompt and robust response to SM-020.

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The company said that all nine tumours demonstrated a partial or total reduction in clinically visible tumours.

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The treatment was also found to be well tolerated without any drug-related adverse events and only rare, mild-to-moderate severity application site reactions.

The company also plans to seek orphan drugs and fast-track designations for SM-020, which will be used to treat laBCC and prevent BCC in Gorlin Syndrome patients. Pivotal trials will follow.

Alongside this, DermBiont is considering options for its seborrheic keratoses (SK) programme following the reprioritisation of SM-020 for laBCC and Gorlin Syndrome.

DermBiont CEO Dr Karl Beutner said: “We are excited about these early results in BCC and the potential for a topical product for the treatment of laBCC and the prevention of BCCs in Gorlin Syndrome.

“An effective topical treatment would be welcomed by patients with laBCC given the limitations and side effects of the currently approved oral hedgehog inhibitors, while also providing patients with Gorlin Syndrome with an alternative to expensive and painful surgical procedures to remove chronic BCCs that result in significant scarring, require post-operative wound care, and lead to significant down time.”