DermBiont’s bet on SeylanMED has delivered a win in phase 2. Twenty months after acquiring the topical drug candidate SM-020, DermBiont has linked the prospect to improved outcomes in people with benign tumors, causing the phase 2 clinical trial to meet its primary and secondary endpoints.
Boston-based DermBiont bought SeylanMED to add SM-020 to its pipeline in 2020, positioning it to trial the topical AKT inhibitor gel in the treatment of the noncancerous skin growth seborrheic keratosis. As it stands, physicians typically scrape the growths off in a procedure known as curettage. However, the risk of side effects such as scarring leaves scope to improve on the standard of care.
DermBiont is advancing SM-020 in the belief it can improve outcomes without exposing patients to the potential side effects associated with curettage. The phase 2 clinical trial represented an early test of that belief.
The adaptive trial tested three treatment regimens—twice daily for 14 days, twice daily for 28 days and pulse dosing for 28 days—of 1% SM-020 gel on four seborrheic keratosis in cohorts of five patients. All the participants on the 28-day regimens experienced at least a one-point improvement on the physician lesion assessment, the primary endpoint of the clinical trial.
In 52% of recipients on a 28-day regimen, the lesions cleared completely, as indicated by a score of zero on the physician scale. DermBiont said it saw improvements in the 14-day cohort, too, but the effect was most pronounced in patients who received SM-020 for longer. With the trial reporting no drug-related adverse events or severe adverse events, DermBiont is now plotting further development.
“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,” Emma Taylor, M.D., chief medical officer at DermBiont, said in a statement.
DermBiont is enrolling another three cohorts in the midphase study to assess the effect of SM-020 on facial, intertriginous and under occlusion seborrheic keratosis as well as to optimize dosing. A larger phase 2 trial is planned for early next year, with phase 3 studies potentially following in the first quarter of 2024.