Date: 2014-07-08
Type of information: Results
phase: 2
Announcement: results
Company: Dignity Sciences (Ireland)
Product: DS107E (DGLA cream)
Action mechanism:
Disease: atopic dermatitis
Therapeutic area: Dermatological diseases - Immunological diseases - Inflammatory diseases
Country:
Trial details:
Latest
news: * On July 8, 2014, Dignity Sciences, a privately held biopharmaceutical company, announced positive Phase II results for DS107E (DGLA cream), as a topical treatment for atopic dermatitis.This study was a randomized, placebo-controlled, double-blind, multi-centre Phase II study to investigate the efficacy and safety of topically applied DS107E (DGLA cream) and the dose-response of three doses (0.1%, 1%, 5%) of DS107E and placebo in patients who have mild or moderate atopic dermatitis. The study showed an overall dose related response improvement in the change from baseline to end of treatment (28 days) for the primary efficacy variable, Modified Eczema Area and Severity Index (mEASI). The changes observed were statistically significant from baseline.
Furthermore, all secondary efficacy variables [the Investigator\'s Global Assessment (IGA), the pruritus visual analogue scale (VAS), the Patient Orientated Eczema Measure (POEM), and the Dermatology Life Quality Index (DLQI)], showed a consistent dose related response trend of improvement from baseline to end of treatment (28 days). This trend of improvement displayed no evidence of response plateau across the endpoints. All doses were found to be well tolerated. Dignity Sciences said that although the trial was not powered to show significant differences between treatment arms, the findings were clinically significant in the 1% and 5% DS107E dose groups. The data supports the utility of topically applied DS107E as a safe and effective drug for the treatment of atopic dermatitis and further informs dose selection for progressing the compound into Phase III trials.
