Sarepta to Initiate Part B of Duchenne Study After FDA Input

 Company Anticipates Part B of MOMENTUM to Serve as Pivotal Study for SRP-5051 and to Seek Accelerated Approval if Successful

- Ambulatory and Non-Ambulatory Patients Between the Ages of 7 to 21 Will Be Eligible to Enroll in Part B of MOMENTUM

 Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that following positive interactions with the U.S. Food and Drug Administration (FDA), the Company plans to initiate Part B of the MOMENTUM study (Study 5051-201), in the fourth quarter. MOMENTUM is a global trial investigating the use of SRP-5051, the Company’s next-generation peptide-conjugated phosphorodiamidate morpholino oligomer (PPMO) to treat patients with Duchenne muscular dystrophy who are amenable to exon 51 skipping.

The study will enroll between 20-40 patients between ages 7 to 21 amenable to exon 51 skipping who are naïve to SRP-5051. Additionally, those previously dosed in Study 5051-201, Part A or Study 5051-102 who meet the entrance criteria will be eligible to participate. Both ambulatory and non-ambulatory patients are eligible for participation. The Company will submit the protocol in the next week.

https://finance.yahoo.com/news/sarepta-therapeutics-initiate-part-b-123000448.html