Aevi Genomic Medicine had all its eggs in one pot. And this morning, that pot got smashed by a landslide of bad data.
Aevi says that its genetic approach to ADHD failed to hit the primary endpoint in a study dubbed SAGA. AEVI-001 failed to significantly help ADHD patients with mutations that throw a monkey wrench in the mGluR network, disrupting glutamate.
The company’s stock $GNMX was eviscerated, plunging 68% on the news.
Investigators did tease out silver linings, though. There was some encouragement on the inattention subscale. And if you just look at the patients who responded, there was a significant gain.
More than one in five ADHD patients have the genetic mutation, and Aevi still believes that it’s on the right track to treating them with a more personalized therapy. But that is a tough sale at this stage of the game.
Aevi lists five different programs for AEVI-001 related to the mGluR mutation. The mid-stage ADHD study was the most advanced. It also has an early-stage drug in development.
“While we are disappointed that the SAGA trial did not achieve statistical significance on the primary endpoint of improvement on ADHD-RS, we are very encouraged by the clinically and statistically significant results we achieved on the ADHD-RS and CGI-I responder analyses,” said Garry Neil, the chief scientist at Aevi Genomic Medicine. “There is a clear signal of efficacy and clinical benefit with AEVI-001 at the highest dose. The drug demonstrated a dose-response limited by the maximum dose of 400 mg BID and a favorable safety profile.”
Principal investigator Robert Findling added:”Although the SAGA trial did not meet its primary endpoint, the clinical results highlight a clear potential to benefit patients. I look forward to working with Aevi Genomics to better understand these results and further develop the molecule.”
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 35,200+ biopharma pros who read Endpoints News by email every day.Free Subscription