BRF Entrepreneurial Accelerator Program (EAP) portfolio company Embera NeuroTherapeutics has announced completion of its Series B financing that, combined with two grant awards, will fund initial EMB-001 Phase 2 clinical studies. A clinical stage pharmaceutical company, Embera’s EMB-001 is a novel pharmaceutical treatment being developed for smoking cessation and cocaine use disorder. Embera licensed the EMB-001 technology from LSU Health Sciences Center Shreveport.

 

The first grant comes from the National Institute on Drug Abuse of the National Institutes of Health (NIDA) and is the final portion of the three-year grant award which totaled $11.1 million. This award will fund a Phase 2 efficacy study of EMB-001 in cocaine use disorder.

 

The second grant award is from the Rose Research Center (RRC) in North Carolina, which will evaluate EMB-001 as a potential smoking cessation product in a Phase 2a efficacy clinical study. The study will be part of RRC’s five-year grant from the Foundation for a Smoke-Free World to evaluate effective smoking cessation treatments. As part of the RRC award, Embera received a grant from the Foundation for a Smoke-Free World to support the manufacturing of EMB-001 clinical trial material for the study.

 

Both Phase 2 studies are expected to begin dosing subjects in the first quarter of 2020.

 

“We are excited to fund and investigate EMB-001 in Phase 2a clinical study in smoking cessation,” said Dr. Jed Rose, President and CEO of RRC. “EMB-001 simultaneously modulates multiple pathways in the human stress response and is a promising candidate as we elucidate the biological mechanisms underlying tobacco addiction on our mission to promote the development of more safe and effective treatments to address what remains a major unmet need.”

 

“The grant awards from NIDA and RRC as well as the continued support from our investors, particularly those in Louisiana, put our drug on the path to potentially change addiction treatment,” said Bob Linke, President and CEO of Embera. “Cocaine overdose remains a serious issue in the United States where there are currently no approved treatments. Smoking continues to be the leading preventable cause of death. There is a real need for an effective treatment option to address these addiction disorders.”

 

Embera has also announced the addition of Bruce McCarthy, M.D. to the leadership team as Chief Medical Officer. Dr. McCarthy previously led neuroscience development programs at Abbott and Pfizer as well as a development stage neuroscience company, Afferent. In addition, Gary Connor, RN, has been named Chief Operating Officer and will continue his responsibilities as Vice President of Clinical Operations overseeing all operating functions of the company.

 

“We are pleased to welcome Dr. McCarthy to our executive team,” said Linke. “Dr. McCarthy’s expertise and experience will add unparalleled breadth and depth to our clinical development as we advance EMB-001 into two important Phase 2 clinical studies. We also look forward to Gary’s expanded leadership role as COO. He joined Embera as EMB-001 entered clinical development and has played a pivotal role overseeing EMB-001 clinical operations from Investigational New Drug filing through initiation of Phase 2 development.”

 

Embera is a portfolio company of EAP, a public-private partnership between local government and BRF (formerly Biomedical Research Foundation) to provide services to innovative startups that have high growth potential.

 

“This announcement from Embera is a fundamental part of what BRF and the Entrepreneurial Accelerator Program are working to achieve. We are helping take a locally developed technology and working to develop and commercialize it,” stated Dave Smith, Executive Director of EAP. “North Louisiana is full of innovative ideas, particularly at the university level, where innovators are researching and developing biomedical technology that could change the way we treat prominent diseases and addictions.”

 

About the Entrepreneurial Accelerator Program
EAP, an initiative of BRF, is a public-private partnership to diversify the regional economy, create jobs and expand the area’s tax base by providing services to innovative startups that have high growth potential. EAP has helped its companies create more than 240 jobs with an annual payroll of $13.4 million. EAP has screened 889 ideas and provided services to 284 companies that have raised almost $100 million in capital.

 

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 responses that drive craving and relapse associated with these disorders. Embera is advancing EMB-001 development programs in cocaine use disorder and smoking cessation. www.emberaneuro.com

 

About EMB-001
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 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 drugs, cues and stressors that contribute to relapse in addiction. EMB-001 may potentially reduce the cravings and loss of control that drive relapse in addiction, by uniquely targeting multiple pathways, thereby possibly maximizing potential efficacy. Therapies that reduce cravings and relapse and thus result in long-term abstinence and recovery would be significant contributions to the treatment of a broad range of addictions.

 

Note: The cocaine use disorder clinical research discussed in this press release will be supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number U01DA038879. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.