Trophos, a biopharmaceutical company specialising in the discovery and development of drugs for neurodegenerative diseases, announced today the successful completion of Phase Ib clinical studies for its lead compound TRO19622. The completed studies include a one month compliance, tolerance and safety study conducted in 36 ALS patients at doses of 125 mg, 250 mg and 500 mg administered orally, once a day, plus two drug-drug interaction studies conducted in healthy volunteers. TRO19622 is in clinical development for motoneuron diseases, amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease) and spinal muscular atrophy (SMA), as well as for painful diabetic neuropathy.

The studies demonstrated that, in ALS patients, TRO19622 is well tolerated and exceeded the exposure level predicted to achieve efficacy via the oral route at doses =250mg per day. In healthy volunteers, TRO19622 exposure levels were approximately 30% higher after repeated dosing with riluzole for which bioequivalence was shown before and after repeated dosing with TRO19622. In these three Phase Ib studies, TRO19622 continues to demonstrate an excellent clinical safety profile in all subjects receiving drug substance.
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