DS Biopharma announces successful trial results for oral treatment for atopic dermatitis

DS Biopharma announced positive results from a phase 2a clinical trial of DS107 as an oral treatment in patients with moderate-to-severe atopic dermatitis.

The randomized, multi-center, placebo-controlled study was conducted for eight weeks in North America, according to a press release. The efficacy and safety of orally administered DS107 (active pharmaceutical ingredient DGLA) were measured in 102 patients.

“Based on the FDA standard primary efficacy end point for atopic dermatitis clinical trials (a 2 point drop in the Investigator Global Assessment [IGA] as well as an end of treatment IGA of 0 [clear] or 1 [almost clear], the overall result from the intent to treat (ITT) analysis showed a clinically significant trend (P =.057) in favor of DS107 over placebo,” according to the release.

ITT analysis revealed a statistically significant improvement in DS107 treatment compared with placebo in a subgroup of 67 patients with moderate atopic dermatitis.

Patients treated with DS107 had a significant reduction in itch using the pruritus score on the Visual Analog Scale (P=.015) within four weeks of dosing, which was a secondary endpoint, according to the release.

Oral DS107 was well-tolerated, with no adverse events reported for either treatment groups, according to the release.

Dublin, Ireland-based DS Biopharma reports it plans to present full results of the study at a dermatology conference in 2016.

Reference: www.dsbiopharma.com