The Company said the findings were clinically significant in the 1% and 5% DS107E dose groups and further informed dose selection for progressing the compound into Phase III trials.
Dublin, Ireland (PRWEB) July 08, 2014
Dignity Sciences Limited, a privately held biopharmaceutical company, today 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 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 improvement trend from baseline to end of treatment (28 days). This improvement trend displayed no evidence of plateauing across the endpoints. All doses were found to be well tolerated.
Commenting on the results, 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.
About Dignity Sciences
Dignity Sciences, a privately held biopharmaceutical company, was established to discover and develop scientifically innovative healthcare solutions that improve the quality of life of people with diseases for which current therapies are unsatisfactory. Dignity Sciences is led by recognized experts in developing fatty acids, including their bioactive derivatives, for the treatment of human disease.