Satellos Bioscience (MSCL.TO) said on Thursday that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for forazapadin.
Forazapadin is being investigated as a treatment for facioscapulohumeral muscular dystrophy (FSHD), a genetic disease that is one of the most common forms of muscular dystrophy. The company plans to initiate a Phase 2 clinical study in FSHD in the fourth quarter of this year.
FSHD Canada Foundation will also provide up to $5 million in milestone payments over five quarters in return for a capped revenue-sharing interest in future FSHD-related proceeds, a statement said. Funds will support a Phase 2 proof-of-concept study to evaluate the safety, and potential efficacy of forazapadin at 60 mg and 120 mg doses in adults aged 18 and older who are living with FSHD.
The IND clearance represents the second clinical indication for forazapadin, which is also being evaluated for Duchenne muscular dystrophy (DMD). Preliminary data from a Phase 2 trial in adults living with DMD may suggest possible muscle regeneration after six months of treatment at 60 mg, the company said.
"We are excited to receive FDA clearance of our IND application for forazapadin in a second disease indication, one for which there are currently no approved therapies," said Wildon Farwell, chief medical officer of Satellos.
Satellos shares were last seen down CA$0.16 at CA$12.01 on the Toronto Stock Exchange.
Price: $12.01, Change: $-0.16, Percent Change: -1.31%