Technoderma Medicines, Inc. (“the Company”), a clinical stage biopharmaceutical company, is pleased to report that the Company has completed its Phase 2a clinical trial (NCT05802173) of TDM-105795 topical solution for Androgenetic Alopecia (AGA). This Proof-of-Concept clinical trial in the AGA program included daily dosing for four months in a study entitled, “A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Multi-Dose Study to Evaluate the Efficacy and Safety of TDM-105795 in Male Subjects with Androgenetic Alopecia”. Study objectives were to evaluate preliminary efficacy, safety and pharmacokinetics of topical TDM-105795; thirteen U.S. clinical sites participated in this study under an open IND with FDA. Evaluation of efficacy by measurement of non-vellus Target Area Hair Count (TAHC) showed mean changes from baseline of 24.3 hairs with the high label strength (0.02%) and 20.3 hairs with the low label strength (0.0025%) topical solution, compared to 14.0 hairs with placebo in 1 cm2 test areas; randomization was 1:1:1 with 71 patients enrolled. Both label strengths of TDM-105795 were well tolerated with no material safety issues identified. Bioanalytical results show that once daily application of TDM-105795 topical solution at either dose produced extremely low to no systemic exposure.
Arthur P. Bertolino, MD, PhD, MBA, Chief Medical Officer at Technoderma Medicines commented, “We are excited to see that TDM-105795 in the current Phase 2 testing has demonstrated hair growth in AGA with a very favorable safety profile. We look forward to moving the clinical program forward to better assess how longer-term treatment is able to provide global improvement in hair coverage.”
“This is another major milestone for the Company that further increases confidence in our pipeline programs to produce and develop clinically useful new chemical entities in dermatology,” said Zengquan Wang, PhD, Chief Executive Officer at Technoderma Medicines. “We are committed to developing a portfolio of innovative dermatology drug candidates.”