The biopharma Atai Life Sciences (Nasdaq:ATAI) subsidiary GABA Therapeutics is sharing positive results from a Phase 1 study of GRX-917, a deuterated form of etifoxine, which the German firm Hoechst developed in the 1960s. Sanofi-Aventis eventually subsumed Hoechst in 2004.
Atai investigated the safety, tolerability and pharmacokinetic profile of orally administered GRX-917 in a Phase 1 study.
The company is developing GRX-917 for generalized anxiety disorder (GAD).
An improved safety profile than benzodiazepines?
The company believes the GRX-917 could have a better safety profile than traditional benzodiazepines.
“Based on etifoxine’s safety and efficacy profile, we believe GRX-917 will offer a differentiated treatment for GAD with fewer side effects—such as sedation, respiratory depression, and withdrawal,” said Dr. Mario Saltarelli, chief medical officer of GABA Therapeutics.
The company noted that the drug candidate was well tolerated.
Investigators noticed adverse events in 53% (17/32) recipients of GRX-917 in the single-ascending dose (SAD) trial portion. In addition, they noticed that 50% (5/10) of placebo recipients had adverse events.
Overall, compared to the placebo, GRX-917 was well-tolerated and neither dose-related, nor dose-limiting adverse events were observed. There were no serious adverse events reported nor discontinuations due to drug administration. Furthermore, in contrast to current first-line anxiety disorder treatments such as benzodiazepines, sedation was found to be comparable to placebo.
Etifoxine currently remains in limited use
The drug, which has the trade name Stresam, is currently available in several markets, including in the European Union. Early last year, EU regulators decided that etifoxine could be used for anxiety disorders but not in “patients who previously had severe skin reactions or severe liver problems” after taking the drug.
GABA Therapeutics notes on its website that the original form of the drug was never introduced in the U.S. Hoechst eventually sold the rights to the drug.
GABA claims that GRX-917 is a patented “vastly improved variant of etifoxine.”
Etifoxine has been off-patent since 1979.
Last month, another Atai subsidiary, Kures, announced inconclusive data regarding the impact of the kratom-derived compound KUR-101 on respiration in a Phase 1 study. Its stock dipped about 9% to $2.77.
Since then, Atai’s share price has continued to slide, recently falling about 6% to $1.71.
Filed Under: clinical trials, Drug Discovery, Psychiatric/psychotropic drugs