Shares of Solid Biosciences Inc. (NASDAQ: SLDB) has traded up 70.44% after the company announced that the US Food and Drug Administration (FDA) gave the permission to resume the IGNITE DMD Phase I/II clinical trial of the company. On July 24, 2020, the company has revealed that it has received the written notice from FDA that its Phase I/II clinical trial of IGNITE DMD will be halted. FDA has requested the information and safety and efficacy data related to the trial.
Solid Biosciences has provided all the necessary details about the IGNITE DMD Phase I/II clinical trial. The company’s data has fulfilled all the requirements of the FDA and satisfied the drug administration authority. The company has promised to share all the manufacturing details with the FDA and all the changes that remove the majority of empty viral capsids, allowing target dosing to be achieved with fewer viral particles.
The step of the company to lessen the total amount of virus delivered to each patient is to aid safe dosing of SGT-001 for the duration of the IGNITE DMD trial. In July, the written notification which the company received from FDA has also requested the comparability between SGT-001 made using Solid’s prior manufacturing process and its current, improved process.
Solid Biosciences has received the FDA acknowledgment by giving the full details of SGT-001 two manufacturing processes. FDA has earlier halted the IGNITE DMD trial after the adverse effects of dosing in the sixth patients in November 2019. Solid Biosciences then gave all the details to the FDA in April 2020.
In May 2020, the company received the notice of hold on the IGNITE DMD clinical trial. And in July FDA has requested manufacturing information, updated safety, and efficacy data for all patients dosed, and providing direction on total viral load to be injected per patient.
Solid Biosciences Inc. (NASDAQ: SLDB) shares were trading up70.44% at $3.46 on Thursday. Solid Biosciences Inc. share price went from a low point around $1.93 to briefly over $13.58 in the past 52 weeks, though shares have since pulled back to $3.46. It has moved up 79.27% from its 52-weeks low and moved down -74.52% from its 52-weeks high. SLDB market cap has remained high, hitting $152.66 million at the time of writing.
SGT-001 of Solid Biosciences is a novel adeno-associated viral (AAV) vector-mediated gene transfer therapy manufactured to treat the underlying genetic cause of Duchenne. Duchenne is caused by mutations in the dystrophin gene that result in the absence or near absence of dystrophin protein.