image credit: Freepik

FDA demands more data from Solid Bio to lift gene therapy hold

July 27, 2020

The FDA has maintained a clinical hold on a phase 1/2 clinical trial of Solid Biosciences’ gene therapy treatment for Duchenne muscular dystrophy (DMD). Solid Bio will need to submit more information on subjects including the total viral load per patient to persuade the FDA to lift the clinical hold.

SGT-001, the adeno-associated viral vector-mediated gene transfer therapy being tested in the trial, has run into repeated problems across its time in the clinic. The latest stage of the gene therapy’s troubled development began in November, when the FDA placed a phase 1/2 trial on clinical hold in response to a case of acute kidney injury and other symptoms in a child who received the high dose of SGT-001.

Read More on FierceBiotech