DS107G-01 – Successful completion of Phase I Oral DGLA clinical trial

DS Biopharma finds that orally administered DGLA distributes well to the skin resulting in high dermal bioavailability.

DS Biopharma, a privately held biopharmaceutical company, today announced the successful completion of a Phase I trial with DS107G, an oral formulation of Dihomo Gamma Linolenic Acid (DGLA).

This study was a randomized, placebo-controlled, double-blind, single-ascending and multiple dose Phase I clinical trial to assess the safety, pharmacokinetics and effect of food on DS107G in healthy subjects.

The study confirmed the benign safety profile of DGLA following both single and multiple oral doses over 28 days, thereby achieving the trial’s primary safety objective. In addition, orally administered DGLA distributed well to the skin resulting in high dermal bioavailability which has important clinical implications. It was found that free DGLA skin blister fluid concentrations were similar to plasma concentrations after about 8 days of repeated dosing.

Commenting on the results, DS Biopharma said that given the importance of DGLA for healthy skin, the large increase in skin concentrations of DGLA and the safety profile observed, DS107G (oral DGLA) is a strong candidate for the treatment of inflammatory skin diseases. A topical DGLA formulation (DS107E) was recently reported to result in an overall dose response improvement in a Phase II Atopic Dermatitis clinical trial.

The detailed analysis of these clinically significant results supports progressing the compound into a Phase II trial.

About DS Biopharma

DS Biopharma, 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. DS Biopharma is led by recognized experts in developing fatty acids, including their bioactive derivatives, for the treatment of human disease.

 

Contact:

DS Biopharma: investorrelations@dsbiopharma.com, +35312933590

 

Updated from Dignity Sciences to DS Biopharma as of 11th May 2015