Phytopharm's Myogane enters Ph Ib UK study

Cambridgeshire, UK-based Phytopharm has been granted clearance from the domestic drug regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA) to commence a Phase Ib healthy volunteer clinical study for Myogane, its novel orally-active neurotrophic factor inducer for amyotrophic lateral sclerosis, the most prevalent form of motor neurone disease.

This residential healthy volunteer clinical study utilizes a randomized, double-blind, placebo-controlled design with a new liquid formulation of Myogane. ALS patients have difficulty in swallowing and this new formulation aims to provide optimal ease of use for the subjects. The study will evaluate the safety, tolerability and pharmacokinetic profile of single oral doses escalated across groups of healthy adults and results are expected in the third quarter.

Phytopharm has already successfully completed a Phase Ia healthy volunteer clinical study with Myogane formulated as a capsule, which demonstrated an excellent overall safety profile for the product. The study was conducted under an Investigational New Drug from the US Food and Drug Administration which also granted Orphan Drug and fast track designation to Myogane for ALS. The condition, also known as Lou Gehring's disease, is a fatal neurodegenerative disorder characterized by progressive degeneration of both upper and lower motor neurones which leads to severe muscle weakness and wasting followed by paralysis. 350,000 patients suffer from ALS worldwide, of whom 50% die within 18 months of diagnosis.