The US Food and Drug Administration (FDA) has granted Fast Track Designation to a treatment for amyotrophic lateral sclerosis (ALS). 

Tazbentetol, developed by biopharmaceutical company Spinogenix, is a once-a-day pill with potential to restore synapses, the key connections between neurons that allow people to think, plan, remember and control movement. 

In 2021, the FDA granted Orphan Drug designation to tazbentetol for the treatment of ALS. With this Fast Track Designation, Spinogenix can expedite the development and review of tazbentetol in ALS. 

In December, Spinogenix announced results from the Phase IIa study of tazbentetol in ALS, demonstrating a favourable safety and tolerability profile. Data showed 82% of patients exhibited a stable or improved rate of decline at the end of treatment, as assessed with ALSFRS-R.  

On average, these patients also exhibited a 76% slower rate of decline through six months compared to historical controls matched from the PRO-ACT database.  

“Receiving Fast Track Designation is another significant milestone in our journey to develop a new therapeutic to combat ALS,” said Dr Stella Sarraf, CEO and Founder at Spinogenix.  

“We remain focused on developing tazbentetol as the first investigational therapy designed to restore synapse function. This designation will allow us to work more closely with the FDA in planning our next trial to help accelerate its development to address this critical unmet need.”