Breakthrough synapse-regenerating ALS pill moves to phase 2 human trials

A pioneering once-a-day pill that regenerates nerve cell connections damaged by ALS has been FDA-approved for ongoing clinical trials. The drug is now being given to those with ALS and could be a watershed moment in the treatment of the fatal disease.

Spinogenix, a clinical-stage biopharmaceutical company, has developed SPG302, a unique once-a-day pill that regenerates the gaps, called synapses, between neurons to restore communication.

Following promising results from clinical trials to evaluate the drug’s safety, the FDA has approved the company’s Investigational New Drug (IND) application, paving the way for further trials.

“Having completed the Phase 1 safety study in healthy subjects in Australia, we are thrilled to have gained FDA acceptance of our US IND for SPG302 in ALS,” said Stella Sarraf, Spinogenix’s CEO and founder. “SPG302’s unique approach to regenerating synapses offers a fundamentally different treatment modality, focusing on synapse loss, which is central to ALS.

Current treatments have not sufficiently met the needs of ALS patients, as slowing disease progression alone is not enough. 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.”

Image source: Frank Gaillard, Wikimedia Commons, CC BY-SA 4.0.