Solid Biosciences rocked by clinical hold, shareholders flee

pharmafile | March 15, 2018 | News story | Research and Development Solid Biosciences, biotech, drugs, pharma, pharmaceutical 

Solid Biosciences raised more than a few eyebrows when it only revealed a partial hold from the FDA stalling its lead prospect on the day of its IPO.

This didn’t stop investors flocking to the biotech on the promise of a potential treatment for Duchenne Muscular Dystrophy, which saw its share price rocket from $16 to a peak of $33 in just over a month.

However, after revealing that the FDA had implemented a full clinical hold on its trial into its candidate, SGT-001, investors were substantially more worried this time around, with shares sinking from $26.31 to £12.06 in after-hours trading.

Solid ran into troubles during treatment of its very first patient in the lower-dose trial of its drug. The company revealed in a press release: “Several days after administration the patient was hospitalised due to laboratory findings that included a decrease in platelet count followed by a reduction in red blood cell count and evidence of complement activation. The patient showed no signs or symptoms of coagulopathy (bleeding disorder) and no relevant changes from baseline in liver function tests.”

Solid noted that the patient had responded to medical treatment and showed no signs of further medical problems, but will be assessed further on an outpatient basis.

The FDA classified the event as a ‘Suspected Unexpected Serious Adverse Reaction’ and, as a result, the company has been forced to stop enrolment and dosing in the trial.

It will have to wait on the Clinical Hold letter from the FDA before deciding how to continue pursuing clinical testing of its candidate.

The potential treatment uses adeno-associated viral vector-mediated gene transfer as its mode of action, but it’s one that has hit the headlines after prominent expert, James Wilson, left Solid’s board over concerns about safety.

So far, other companies in the area, Sarepta and Pfizer, have not reported any such difficulties but the news will undoubtedly put the FDA on high-alert regarding potential risks.

Ben Hargreaves

Related Content

FDA approves IMIDEX’s AI-powered device VisiRad XR

The technological pharmaceutical company IMIDEX has been granted clearance from the US Food and Drug …

Artiva Biotherapeutics announces FDA clearance of IND for AlloNK and Rituximab combo

On 16 August 2023, the US Food and Drug Administration (FDA) officially cleared Artiva Biotherapeutics’ …

Zumutor’s cancer drug trial cleared by FDA

On 11 August 2023, the biopharmaceutical company Zumutor Biologics announced that the trial of its …

Latest content