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DermBiont Announces Positive Phase 2 Clinical Trial Data Treating Seborrheic Keratosis with SM-020, the First and Only Targeted Topical Treatment for these Common Benign Tumors

52% of SKs lesions treated for 28 days cleared completely, reaching a PLA score of 0.

100% of SKs lesions treated for 28 days demonstrated at least a one-point drop in their PLA score and patients experienced no application site reactions.

SM-020 is the first and only highly selective topical treatment that results in natural apoptosis of SK cells without cytotoxicity to healthy, normal keratinocytes.

Excerpt from the Press Release:

BOSTON–(BUSINESS WIRE)–DermBiont, a clinical-stage biotechnology company announced today positive results meeting primary and secondary endpoints in a Phase 2 clinical trial with a topical formulation of investigational drug SM-020, a specific and potent AKT inhibitor applied by patients at home to their seborrheic keratoses (SK).

SKs are ​benign clonal tumors of the skin that often appear over the age of thirty-five. Over 80 million Americans and approximately a quarter of the global population have SKs, with the most affected areas including the face, chest, and back. There are currently no patient applied therapies for these tumors.

DermBiont’s Phase 2 adaptive design trial tested a 1% SM-020 Gel on four SK lesions in cohorts of five patients across three different treatment regimens: twice daily for 14 days, twice daily for 28 days, and pulse dosing for 28 days (four days on and four days off). All three cohorts saw improvement and clearance of SKs, with the effect being most pronounced in the two 28-day treatment cohorts.

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