Trophosannounced today that it will receive 6.7 million, or $9.1 million, over the next three years from the Association Francaise contre les Myopathies (AFM) that will cover the costs of testing the efficacy of olesoxime to develop a treatment for spinal muscular atrophy (SMA) patients.
The company is undertaking a protocol assistance procedure with the EMEA to finalize the design of the clinical study and expects the trial to begin at the end of the year.
" Trophos is very pleased to be renewing its long standing strategic partnership with the AFM for the continued development of olesoxime for SMA, which has been instrumental in advancing our SMA program," says Damian Marron, CEO of Trophos. "Olesoxime is uniquely suited for development for this devastating condition, for which no treatments exist today. This program is a key part of our ongoing commitment to rare and underserved motor neuron diseases and this agreement underlines and strengthens our joint efforts to further the clinical development of olesoxime for SMA."
Olesoxime has received orphan drug designation from the FDA, which follows a similar designation by the EMEA, says the company. The drug has already received similar designations for treatment of amyotrophic lateral sclerosis.
Clinical I/IB trials have been completed for both SMA and ALS indications, with Trophos reporting that it was well tolerated and had good efficacy based on once-a-day dosing.