DRM01 is a novel, small molecule designed to inhibit sebum production following topical application currently in development for the treatment of acne.
A direct clinical relationship has been identified between the degree of sebum inhibition and acne improvement. Sebum is an oily matter produced by sebaceous glands in the skin which, when produced in excess, plays a central role in the pathogenesis of acne.
DRM01 is designed to target acetyl coenzyme-A carboxylase, or ACC, an enzyme that plays an important role in the synthesis of fatty acids, which represent an essential component of sebum. Based on preclinical studies, DRM01 inhibits, in a dose-dependent manner, the production of key sebum components in sebum-producing cells. We have also shown that topical administration of DRM01 reduces sebaceous gland size in animals.
In May 2016, we announced topline results from our DRM01 Phase 2b clinical trial in 420 adult patients (18 years and older) with facial acne vulgaris). The clinical study evaluated the safety and efficacy of DRM01 and demonstrated statistically significant improvements in all primary endpoints compared to vehicle at the highest dose and in most primary endpoints at the two lower doses. DRM01 was well-tolerated with adverse events primarily mild or moderate in severity.
Based on these results, we plan to initiate a Phase 3 program to evaluate the safety and efficacy of DRM01 as a potential treatment for acne in adult and adolescent patients. The initiation of this program is targeted for the first half of 2017, subject to an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA).