BioWorld International Correspondent
PARIS - Trophos completed a Phase Ib trial of its lead compound, TRO19622, in amyotrophic lateral sclerosis and announced plans for carrying out a pivotal Phase II/III study.
The Phase Ib trial included a one-month compliance, tolerance and safety study in 36 ALS patients, as well as two drug-drug interaction studies in healthy volunteers. Marseille, France-based Trophos said it demonstrated that TRO19622 was well tolerated, had an excellent clinical safety profile and exceeded the exposure level predicted to achieve efficacy via the oral route at doses superior or equal to 250 mg a day.
On the strength of those results, Trophos decided to initiate a Phase II/III trial to evaluate the efficacy of TRO19622 in ALS (survival and functional benefits) at 10 centers in Europe, subject to regulatory approvals. The company said it is looking for a co-development/licensing partner to undertake the clinical development of TRO 19622 in the U.S.
In September, Trophos was granted orphan drug status in Europe for TRO19622 in the treatment of ALS, having already obtained orphan drug designation in the U.S., also in ALS.
The product has other potential therapeutic applications, moreover, since Trophos is planning to launch a Phase Ib trial in juvenile SMA (spinal muscular atrophy) patients in Europe in the first half of 2007, while a Phase II trial of TRO19622 in diabetic neuropathy was initiated in June this year.