LSUHSC-S receives $3.9M NIDA grant to develop EMB-001 drug for cocaine dependence

Embera NeuroTherapeutics, Inc., a specialty pharmaceutical company developing novel treatments for addiction and obesity, announced today that the Louisiana State University Health Sciences Center (LSUHSC-S) has received a $3.9 million dollar grant from the National Institute on Drug Abuse (NIDA). The grant will support the next stages of development for Embera's drug candidate EMB-001 to treat cocaine dependence, as well as advance EMB-001 into clinical testing. Work done under this grant will also support Embera's clinical development program for EMB-001 for smoking cessation.

EMB-001 is a novel addiction treatment based on discoveries by Dr. Nicholas Goeders, Professor and Head of the Department of Pharmacology, Toxicology & Neuroscience at LSUHSC-S, and licensed exclusively to Embera by LSU. Dr. Goeders also serves as Embera's Chief Scientific Officer, as approved by LSU. In addition to Dr. Goeders' research in cocaine and methamphetamine dependence, Embera has conducted studies in a preclinical model of nicotine dependence, confirming the potential for EMB-001 as a smoking cessation treatment and showing statistically significant performance versus the positive control (varenicline).

Bob Linke, Chief Executive Officer of Embera, said, "We are delighted to receive positive scientific validation and support from NIDA for Dr. Goeders' discoveries and Embera's subsequent development work. We are excited to continue our work with Dr. Goeders to advance the development of EMB-001 to treat cocaine dependence and enable clinical development of EMB-001 for smoking cessation, a $3.5 billion worldwide market."

This innovative treatment approach is based on Dr. Goeders' insights from years of research into the physiologic responses to chronic stress in addiction. EMB-001 is a combination drug that acts by mechanisms distinct from those of existing addiction treatments, and comprises two FDA-approved medications, the benzodiazepine oxazepam and the cortisol synthesis inhibitor metyrapone. Through the modulation of stress-related pathways, EMB-001 targets the drivers of addictive behavior. Clinical activity using EMB-001 has been shown in a pilot study in cocaine-dependent human subjects. In addition, efficacy in cocaine, nicotine and methamphetamine dependence has been demonstrated in preclinical studies.

Dr. Goeders added, "Addiction affects millions of people in the U.S. and results in significant costs to the healthcare system. Cocaine dependence and abuse alone afflict 1.6 million Americans. Despite this, there are no FDA-approved medications for the treatment of cocaine dependence; a compelling need for safe and effective therapies to address this addiction therefore remains. We believe that EMB-001 may have the potential to fulfill this need, and we appreciate the support of NIDA to bring this drug candidate closer to patients."