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.”
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