Phytopharm completes Ph Ib Myogane trial

UK plant-based drugmaker Phytopharm says it has completed a Phase Ib trial of Myogane, its novel, orally-active neurotrophic factor inducer, in healthy volunteers. The drug, which is being developed for the treatment of amyotrophic lateral sclerosis, showed good safety, tolerability and pharmacokinetics up to the highest administered dose of 640mg, the firm stated.

The assessment, which was conducted in the UK with authorization from the country's Medicines and Healthcare products Regulatory Agency (MHRA), also demonstrated that the drug's liquid formulation was easily administered and had an excellent absorption profile, both of which are important characteristics because ALS sufferers often have difficulty swallowing tablet-based medications. In addition, no treatment-related adverse events were observed during the program.

Phytopharm said that, based on the promising results of the Phase Ib study, it intends to seek Orphan Medicinal Product status from the European Medicines Agency (EMEA) during the fourth quarter of the year. The Godmanchester-headquartered company added that the US Food and Drug Administration granted Myogane equivalent Orphan Drug designation in 2004, and has also accepted it for fast-track review (Marketletters passim).