Solid Biosciences Inc. (NASDAQ: SLDB) shares more than doubled on Thursday after the company announced a key update from the U.S. Food and Drug Administration (FDA). Essentially, the agency has decided to lift a clinical hold placed on the firm in July 2020.
Specifically, this clinical hold was on the firm’s Ignite DMD Phase 1/2 clinical trial. The FDA originally had requested further manufacturing information, updated safety and efficacy data for all patients dosed and provided direction on total viral load to be administered per patient.
Accordingly, the FDA has taken into account Solid Bio’s responses to these requests and has acknowledged that the firm satisfactorily has addressed all the concerns and clinical hold questions. Hence, the hold has been lifted.
As part of its commitment to improve its manufacturing processes continuously, the company implemented and shared with the FDA manufacturing process changes that remove the majority of empty viral capsids, allowing target dosing to be achieved with fewer viral particles.
Solid Bio also is reducing the maximum weight of the next two patients dosed to 18 kg per patient, with safety outcomes from these two patients driving potential weight increase of patients dosed subsequently. This reduction, in combination with the delivery of fewer viral particles as a result of the company’s manufacturing process improvements, will reduce patients’ total viral load.
There have been no additional drug-related adverse events up to 30 months following dosing. Additionally, to mitigate the risk of serious drug-related adverse events, Solid is amending the IGNITE DMD clinical protocol to include the prophylactic use of both anti-complement inhibitor eculizumab and C1 esterase inhibitor, and it is increasing the prednisone dose in the first month after dosing.
Excluding Thursday’s move, Solid Biosciences stock had underperformed the broad markets with about 54% decline year to date. In the past 52 weeks, the share price was down closer to 79%.
Solid Biosciences stock traded up about 122% to $4.52 on Thursday, in a 52-week range of $1.93 to $13.58. The consensus price target is $3.00.
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