FDA clears investigational new drug application for clinical trial of ALS pill

The FDA has cleared an investigational new drug application for a phase 1/2 clinical trial to examine a novel, once-daily pill for the treatment of individuals with amyotrophic lateral sclerosis, according to the manufacturer.

Spinogenix Inc., a clinical-stage biopharmaceutical company based in Southern California, announced in the release that the pending study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of SPG302 for those diagnosed with the degenerative neuromuscular condition.

SPG302 had previously been granted orphan drug designation by the FDA and is undergoing a phase 1/2 study in Australia that completed dosing of healthy volunteers in April.

“Having completed the phase 1 safety study in healthy subjects in Australia, we are thrilled to have gained FDA acceptance of our U.S. [investigational new drug application] for SPG302 in ALS,” Spinogenix founder and CEO Stella Sarraf, PhD, said in the release. “We are committed to advancing SPG302 with the hope of providing a new, transformative therapeutic that can significantly improve the lives of those battling this devastating disease.”