Enrollment Completed in DRM01 Phase 2b Acne Trial; Topline Data Expected in 2Q16
Topline Data for DRM04 Phase 3 Hyperhidrosis Program Expected Mid-2016
“We are thrilled with the completion of patient enrollment for our Phase 2b trial for DRM01 in acne, the timing of which was consistent with our original expectations, and with enrollment for our DRM04 Phase 3 clinical trials, which has progressed faster than anticipated,” stated Luis Peña, executive vice president, Product Development of
DRM01 Phase 2b Clinical Program
The DRM01 Phase 2b trial is a randomized, multi-center, double-blind, parallel-group, vehicle-controlled study designed to assess the safety and efficacy of DRM01 compared to vehicle in patients with facial acne vulgaris. The goal of the study is to establish the optimal dose for a potential Phase 3 program. In the Phase 2b trial, approximately 400 adult patients with moderate-to-severe facial acne vulgaris were randomized into five separate arms evaluating different DRM01 dosing regimens compared to vehicle. Approximately 300 patients will receive DRM01, with 100 patients in each of three DRM01 treatment arms, and approximately 100 patients will receive vehicle. Consistent with the preceding Phase 2a trial and in accordance with the published
DRM04 Phase 3 Clinical Program
The DRM04 Phase 3 program is designed to assess the safety and efficacy of DRM04 to support a potential New Drug Application (NDA) submission to the
The ATMOS-1 and ATMOS-2 studies are identical, randomized, double-blind, vehicle-controlled trials enrolling a total of approximately 660 adult and adolescent (ages nine and older) patients with primary axillary hyperhidrosis. In each of these trials, 220 patients will receive DRM04 and 110 patients will receive vehicle. Patients are instructed to apply the study product to each axilla (underarm) once daily for four weeks using topical wipes containing either DRM04 or vehicle only. The co-primary endpoints are the average absolute change from baseline in gravimetrically-measured sweat production and the proportion of patients who achieve at least a four-point improvement from baseline in disease severity as measured by the Axillary Sweating Daily Diary (ASDD), the company’s proprietary patient-reported outcome (PRO) instrument. Secondary efficacy endpoints include (1) the proportion of subjects who have at least a two-grade improvement from baseline in their score on the Hyperhidrosis Disease Severity Scale (HDSS), wherein patients rate the severity of their disease on a four-point scale, and (2) the proportion of subjects with at least a 50% reduction from baseline in gravimetrically-measured sweat production. Both the primary and secondary endpoints will be assessed at the end of the four-week treatment period.
Topline results from the ATMOS-1 and ATMOS-2 trials are now expected mid-2016. In the open-label ARIDO study assessing the long-term safety of DRM04, patients from either of the ATMOS Phase 3 studies are permitted to continue to receive active treatment for up to an additional 44 weeks from the end of the 4-week treatment periods in the ATMOS studies. Pending the successful completion of these studies and other registration-enabling activities,
DRM01 is a novel, topical, small-molecule sebum inhibitor in development for the treatment of acne. Sebum is an oily substance made up of lipids produced by glands in the skin called sebaceous glands, and excessive sebum production is an important aspect of acne that is not addressed by available topical therapies. DRM01 is designed to exert its effect by inhibiting acetyl coenzyme-A carboxylase, an enzyme that plays an important role in the synthesis of fatty acids, a type of lipid that represents an essential component of the majority of sebum lipids.
DRM04 is a topical, small-molecule, anticholinergic product in clinical development for the treatment of hyperhidrosis. DRM04 is designed to inhibit sweat production by blocking the interaction between acetylcholine and the cholinergic receptors responsible for sweat gland activation.
The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements with respect to the goal of delivering new therapies for patients with dermatologic diseases; the use of DRM01 as a safe and effective treatment for acne and DRM04 as a safe and effective treatment for hyperhidrosis; the description of the DRM01 Phase 2b program; the design of a potential DRM01 Phase 3 program; the description of and enrollment expectations for the DRM04 Phase 3 studies; the successful completion of, and timing expectations for the receipt and announcement of topline efficacy and safety data from, the DRM01 Phase 2b and DRM04 Phase 3 studies; the company’s anticipated position and events in 2016; and the potential NDA submission to the
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