DermBiont has completed enrollment in a Phase 2b clinical trial of SM-020 gel 1.0% for the treatment of seborrheic keratoses.
“We are pleased to have completed enrollment in our CT-213 clinical trial evaluating SM-020 gel 1.0% for the treatment of SK lesions, the most common benign tumors of the skin,” shares Karl Beutner, M.D., Ph.D., CEO, and Co-Founder of DermBiont, in a news release. “We believe that positive results from this trial will keep us on track for an End of Phase 2 Meeting with the FDA and ultimate regulatory alignment for designing DermBiont’s Phase 3 pivotal trial.”
CT-213 is a Phase 2b randomized, double-blind, vehicle-controlled clinical trial in 60 subjects with five to ten SK target lesions treated with SM-020 gel 1.0% or vehicle twice daily for 28 days. The primary endpoints of the study are the proportion of SK lesions with a Physician Lesion Assessment (PLA) score of clear (PLA=0) at last visit and the safety of SM-020 gel 1.0% based on application site reactions. Key secondary endpoints include the proportion of SKs with clear (PLA=0) or nearly clear (PLA=1), proportion of subjects with 100% of lesions clear (PLA=0), proportion of subjects with 60% of lesions clear (PLA=0), and the diagnostic accuracy of clinical versus dermoscopy assessments.
DermBiont currently anticipates that data will be available in Q3 2024. The data generated in CT-213 as well as clinical and non-clinical work, including various formulation and development studies, will support an End of Phase 2 Meeting request package to the FDA in Q4 2024.
“The data we have generated to date treating SKs with SM-020 gel 1.0% is highly encouraging, providing a safe and effective treatment option for patients whose only other option would be painful ablative surgical procedures that require multiple days of post-operative wound care and carry meaningful risk of scarring,” adds Nichola Eliovits, Co-Founder and Chief Business Officer of DermBiont.
Other Anticipated Clinical Milestones for 2024
Additionally, DermBiont is initiating a Phase 2a (CT-217) open-label trial in up to 40 subjects with one to five basal cell carcinomas (BCC) or squamous cell carcinoma in situ (SCCIS). This open label trial’s primary endpoints are the reduction in greatest tumor diameter at week 6 compared to baseline, and the safety of drug product for BCCs or SCCISs based on application site reactions. Secondary endpoints include the percentage of BCCs or SCCISs that achieve histologic cure at week 6.
“We are excited to initiate the CT-217 trial evaluating efficacy and safety in subjects with nodular, superficial, and sclerosing BCC tumors, following an initial finding where a BCC lesion was highly responsive to treatment with this drug product. A detailed analyses of the drug’s mechanism of action demonstrated activity on the pathways known to be the cause of BCCs,” says Emma Taylor, MD, Chief Medical Officer at DermBiont. “If our initial finding is confirmed, a patient applied targeted topical product with excellent safety and tolerability would represent a major breakthrough for patients suffering from BCCs (the most frequently diagnosed skin cancer), especially for patients with Gorlin Syndrome.”
DermBiont is also commencing a randomized, observer-blind, vehicle-controlled Phase 2b trial (CT-214) of SM-030 in 138 subjects with melasma in Q2 2024. The CT-214 trial follows positive results in an earlier completed Phase 2a study treating solar lentigos and photoinduced hyperpigmentation, demonstrating comparable efficacy to hydroquinone with superior tolerability and safety given SM-030’s targeted mechanism of action and increasing concerns over hydroquinone’s long-term safety and toxicity.
SM-030 works as a targeted topical to safely downregulate excess production of melanin by melanocytes in the epidermis, addressing the root cause of excess melanin production, and offering patients a viable long-term treatment option to obtain and maintain monochromatic skin, the Company states.
Upcoming Milestones:
- SKs: DermBiont expects to report data from its CT-213 Phase 2b clinical trial of SM-020 gel 1.0% in Q3 2024.
- BCCs and SCCISs: DermBiont expects to initiate its CT-217 Phase 2a clinical trial in Q1 2024 and report data in Q3 2024.
- Melasma: DermBiont anticipates enrolling the first patient in its randomized, observer-blinded, vehicle-controlled CT-214 Phase 2b trial of SM-030 in 138 subjects with melasma in Q2 2024.