Trophos completes Ph Ib TRO19622 program

Trophos, a French biopharmaceutical company specializing in the discovery and development of drugs for neurodegenerative diseases, has completed Phase Ib clinical studies for its lead compound, TRO19622. The completed studies include a one-month compliance, tolerance and safety evaluation conducted in 36 amyotrophic lateral sclerosis patients at doses of 125mg, 250mg and 500mg administered orally, once a day, plus two drug-drug interaction trials conducted in healthy volunteers.

Trophos noted that TRO19622, which is in development for motor neuron diseases, ALS and spinal muscular atrophy, as well as for painful diabetic neuropathy, was well-tolerated and exceeded the exposure level predicted to achieve efficacy via the oral route at doses superior or equal to 250mg per day, in ALS patients.

The firm said that, in healthy volunteers, exposure levels of the agent were approximately 30% higher after repeated dosing with riluzole for which bioequivalence was shown before and after dosing with TRO19622.