Phytopharm Completes Phase Ib Study of Myogane

Phytopharm announced that it has completed a Phase Ib volunteer clinical study of Myogane for orphan motor neurone diseases, of which the most prevalent form is amyotrophic lateral sclerosis (ALS).

According to Phytopharm, the randomized, double-blind, placebo-controlled study demonstrated a good safety, tolerability and pharmacokinetic profile following single oral doses escalated across groups of healthy adult subjects.

The highest dose administered, 640 mg, was well-tolerated with no adverse events and demonstrated an excellent absorption profile, the company added.

The study was conducted in the UK under a clinical trial authorization from the Medicines and Healthcare Products Regulatory Agency. Myogane has previously been granted orphan drug and fast track designation for the treatment of ALS by the FDA, the company said.

Phytopharm added that it intends to request European Union orphan medicinal product status during the fourth quarter.