GABA Therapeutics has continued to progress the development of GRX-917 without any material impact from the COVID-19 pandemic.
GABA Therapeutics recently completed its Phase 1 clinical trial of the anxiolytic etifoxine in Melbourne, Australia, on time and slightly ahead of budget. The two-stage, double-blind, placebo-controlled single and multiple dose study evaluated the pharmacokinetics, pharmacodynamics, and safety of oral etifoxine in 30 normal healthy volunteers.
“We are pleased that the Phase 1 study has provided important PK/PD data for etifoxine that will help enable the preclinical and Phase 1 studies of GRX-917, the deuterated analog of etifoxine.” said Dr. Ian Massey, co-founder and CEO of GABA Therapeutics.
GABA Therapeutics is about to commence an FIM-enabling toxicology program for GRX-917. Manufacture of GRX-917 is proceeding well, and clinical grade material is expected to be available in September. The Phase 1 study of GRX-917 is planned to start dosing in Australia in Q1/2 2021 – COVID-19 permitting.
Clinical studies have shown that etifoxine has comparable speed of onset and anxiolytic efficacy as the world’s top two selling benzodiazepines (Xanax® and Ativan®), without the side effects of sedation, amnesia, ataxia, and dependence associated with benzodiazepines. The drug is non-addictive, and adverse drug effects occurred in just 21 per million patients (0.0021%), based on a pharmacovigilance study released by the French National Agency for the Safety of Medicines and Health Products that found no cases of abuse, misuse, or dependence after analyzing over 14 million prescriptions of etifoxine between 2000 and 2012.
In animals etifoxine acts by increasing endogenous neurosteroids such as allopregnanolone, which are essential for maintaining healthy brain biochemistry. Neurosteroids can induce potent anxiolytic, antidepressant, anticonvulsant, and analgesic effects, mainly through interaction with the GABA channel, the main inhibitory system in the brain.
GABA’s flagship product, GRX-917, the deuterated version of etifoxine, has an identical mechanism of action, biology and pharmacology, as etifoxine, but with improved pharmacokinetics. Based on all the data for etifoxine, GRX-917 will be safer and clinically superior to America’s top two drug classes of anxiolytics: SSRIs/SNRIs and benzodiazepines. Additionally, the drug is not expected to be a controlled substance, since etifoxine is not a controlled substance in France or any other country in which it is sold. Currently, there is no clinically competitive anxiolytic drug on the market.
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