Embera NeuroTherapeutics has received an $11.1 million, 3-year grant from the NIH’s National Institute on Drug Abuse (NIDA) to support continued clinical development of its cocaine addiction treatment EMB-001.
“With this support, we are excited to continue the advancement of our lead candidate through a Phase II proof-of-concept efficacy study,” Embera CMO Michael Detke, M.D., Ph.D., said in a statement.
A patented combination of the FDA-approved drugs—the cortisol synthesis inhibitor metyrapone and the benzodiazepine oxazepam, EMB-001 targets the stress response system as a novel approach to addressing addiction and relapse.
EMB-001 is based on the discoveries of Nicholas Goeders, Ph.D., professor and head of the Department of Pharmacology, Toxicology & Neuroscience at the Louisiana State University (LSU) Health Sciences Center.
LSU has exclusively licensed the candidate to Embera, which in January announced it had successfully completed a Phase I study of the safety and pharmacokinetics of EMB-001 in healthy adult smokers.
In that study, EMB-001 showed itself to be safe and well-tolerated, with a statistically significantly greater effect compared with Chantix® (varenicline). Results from the Phase I study were presented at the Society for Research on Nicotine and Tobacco in February, and at other scientific conferences in the first half of 2016.
In 2012, Embera published results of a randomized, double-blind, placebo-controlled pilot clinical study of EMB-001 in cocaine-dependent subjects. EMB-001 treatment significantly reduced cocaine use compared to placebo, produced significant reductions in cocaine craving, and was well tolerated over the 6-week treatment period.
The candidate’s potential use for addictions to nicotine and methamphetamine, as well as cocaine, has been shown in preclinical studies, while clinical activity was also demonstrated in a pilot study in cocaine-dependent human subjects, according to Embera. There are currently no FDA-approved medications for cocaine-use disorder.
The NIDA grant received by Embera is Award Number U01DA03887