Coyote commences GMP manufacturing process for CNS-102

Coyote is expected to file IND application for CNS-102 for amyotrophic lateral sclerosis (ALS) therapy in the fourth quarter of 2013 and commence a Phase 1 study in early 2014.

Coyote Pharmaceuticals president, CEO and co-founder Hiroaki Serizawa said the company was advised by the FDA to seek fast track designation for CNS-102 in ALS.

"Given that Fast Track designation is not typically discussed until Phase 2 data is produced, we view the FDA’s position as very encouraging for our technology and strategy of targeting heat shock protein induction as a potential treatment for ALS," Serizawa added.