Embera NeuroTherapeutics Secures A-2 Financing to Advance EMB-001 for Addictions Through Phase 1 Clinical Trial
— Erin Gainer, Ph.D., Chief Executive Officer of HRA Pharma, joins Embera as Board observer —
BOSTON and SHREVEPORT, La.–April 10, 2015–Embera NeuroTherapeutics, Inc., a specialty biopharmaceutical company developing novel treatments for smoking cessation, cocaine use disorder and other addictions, today announced that it raised $1.9 million in Series A-2 financing. The funding enables the Company to complete a Phase 1, combined single and multiple rising dose clinical trial evaluating the safety and pharmacokinetics of EMB-001 in volunteers who smoke cigarettes but are otherwise healthy.
Existing investors, angel groups, private individuals and HRA Pharma, based in Paris, participated in the round. HRA Pharma, a strategic investor, is a specialty pharmaceutical company which commercializes Metopirone®. Metopirone’s active component is metyrapone, one of the two molecular components in EMB-001, Embera’s lead drug candidate. HRA’s Chief Executive Officer, Erin Gainer, Ph.D., will serve as a non-voting observer to Embera’s Board of Directors.
“We appreciate that our investors have provided capital to advance our lead candidate through this Phase 1 human study. Data from preclinical and pilot studies suggest potential for EMB-001 as a new treatment for addictions affecting underserved and significant patient populations; for example, the nearly one million U.S. citizens suffering from cocaine use disorder have no approved treatment option,” said Bob Linke, Chief Executive Officer of Embera. “We anticipate initiation of dosing in the next 30 days in order to produce top-line data by the end of 2015.”
“We are excited that Embera is able to utilize metyrapone for its novel drug combination and are happy to support its clinical program,” said Erin Gainer, Ph.D., Chief Executive Officer of HRA Pharma. “As an industry, we need to do better—both for the sake of patients suffering from substance use disorders and the healthcare systems that treat them. The United States alone is burdened by an annual $173 billion cost for medical care related to substance use disorders.”
“New treatment options for addictions are not only drastically needed but also represent an enormous market opportunity. Smokers who attempt to quit spend over $1 billion on prescription and over-the-counter drugs per year in the United States, yet only a small percentage of smokers are able to quit with available treatment options,” said Ross P. Barrett, Partner at investment firm Seven Holdings, LLC and Chairman of Embera’s Board of Directors. “Embera’s novel approach to treating addictions is believed to modulate the brain’s stress pathways. We aim to provide a safer and better alternative to the prescription therapies currently available.”
EMB-001 has been tested with promising results in a published pilot study in cocaine-dependent human subjects, as well as in published preclinical models of nicotine, cocaine and methamphetamine dependence.
EMB-001 is a patented combination product comprising two FDA-approved medications, the cortisol synthesis inhibitor metyrapone and the benzodiazepine oxazepam. The innovation is based on insights into the physiologic responses to chronic stress in addiction.
EMB-001 is thought to act by mechanisms distinct from those of existing addiction treatments and is hypothesized to reduce the increased activity in the stress response system induced by cues that contribute to the acquisition and maintenance of addiction. EMB-001 may potentially reduce the cravings and loss of control that drive addiction by uniquely targeting multiple pathways, to maximize potential efficacy as well as minimize safety and tolerability concerns. Therapies that break these barriers and result in long term abstinence and recovery would be significant contributions to the treatment of a broad range of addictions.
About Embera NeuroTherapeutics
Embera NeuroTherapeutics, Inc. is a clinical-stage pharmaceutical company focused on treating a broad range of addictions where the major clinical challenge is a limited range of effective therapies. Embera is developing a novel drug combination (EMB-001) targeting specific brain functions related to stress response that drive craving and relapse associated with these disorders. Embera is advancing EMB-001 development programs in smoking cessation and cocaine use disorder. www.emberaneuro.com
President and CEO
Embera NeuroTherapeutics, Inc.
MacDougall Biomedical Communications