Prilenia envisions Phase III trial despite ALS drug missing primary endpoint  

Prilenia has announced plans to initiate a Phase III trial in H2 2024 after presenting results at the Annual California ALS Research Summit in Los Angeles, US.

Prilenia Therapeutics’ amyotrophic lateral sclerosis (ALS) therapy pridopidine failed to meet its primary endpoint in a Phase II clinical trial, but the biotech is planning to initiate a Phase III study after pointing out notable findings.

In the Phase II HEALEY ALS platform trial (NCT04615923), pridopidine didn’t yield significant differences in primary or key secondary endpoints that measure disease progression as per the ALS Functional Rating Scale-Revised (ALSFRS-R), and mortality event rate, compared to the placebo.