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.
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.
SKs were classified based on Physician Lesion Assessment (PLA) scores for SKs as follows: PLA 3 (thick: a visible, elevated SK lesion (thickness >1mm), PLA 2 (thin: a visible, elevated SK lesion (thickness ≤1mm), PLA 1 (near clear: a visible, not elevated SK lesion with a surface appearance different from the surrounding skin), and PLA 0 (no visible SK lesion with a surface appearance different from the surrounding skin). In the clinical trial only PLA 2 and 3 SKs were treated.
Trial Results
52% of SKs lesions treated for 28 days cleared completely, reaching a PLA score of 0
100% of SKs lesions treated for 28 days experienced at least a one-point drop in their PLA score
All three treatment arms were well tolerated with no drug-related adverse events or severe adverse events
In the two 28-day treatment cohorts there were no application site reactions reported across patient-reported and investigator-measured reactions: pain, pruritus, erythema, edema and scabbing
“We are delighted to announce that in our first clinical trial with SM-020, we demonstrated >50% total clearance and at least a partial response in 100% of subjects when treating SKs for 28 days,” said Dr. Emma Taylor M.D., Chief Medical Officer at DermBiont. She added that, “We see a clear development path forward for this asset and are excited to provide patients with a new treatment paradigm for seborrheic keratoses that replaces the need for surgical ablation of SKs. As a practicing dermatologist, I see many patients requesting treatment for SKs, and a convenient, painless, at-home, patient-applied nonsurgical intervention would be the preferred modality of care.”
As a result of the initial positive data, DermBiont is enrolling three additional cohorts in the ongoing adaptive Phase 2 trial to treat facial SKs, intertriginous SKs, SKs under occlusion, and optimize dosing. DermBiont plans to initiate a 100+ patient Phase 2 trial in early 2023, and Phase 3 trials could be initiated as early as Q1 2024.
“We founded DermBiont with the intention of treating skin diseases at their root cause; meeting our primary and secondary endpoints in this trial with a well-tolerated topical small molecule candidate is a major milestone in this endeavor,” said Dr. Karl Beutner, M.D. Ph.D., CEO and Co-Founder of DermBiont. “We are only at the beginning of our mission to deliver targeted, topical therapeutics to alleviate unmet patient-needs across many dermatology indications, and we are committed to giving patients the option of effective first-in-class treatments.”