Embera NeuroTherapeutics, Inc., a specialty pharmaceutical company developing novel treatments for drug dependence, smoking cessation and obesity, announced today that the company has retained Exponential Pharma Ventures LLC to assist in establishing a clinical development partnership for its cocaine dependence program with a fully integrated pharmaceutical company. Exponential Pharma Ventures, a company specialized in development of early stage biomedical technology through pharmaceutical partnerships, is seeking a partner to advance Embera’s lead product, EMB-001C into phase 2a clinical trials. The pharmaceutical partner will receive an option to license and commercialize the product after clinical proof of concept. Embera and Exponential have already initiated discussions with prospective partners. EMB-001C is a combination drug product that has recently demonstrated preliminary clinical proof of concept in a randomized, double-blind, placebo–controlled pilot study in cocaine-dependent human subjects.
“We are tremendously excited by EMB-001C’s potential to help the large number of cocaine-dependent patients who currently have no effective therapies to help them break free.”
Bob Linke, CEO of Embera stated: “Exponential Pharma presents a compelling opportunity to collaborate with a pharmaceutical partner in a capital-efficient structure, which we believe is an optimal way to advance this combination drug to human proof of concept.” Mike Webb, Managing Director of Exponential Pharma Ventures commented, “We are tremendously excited by EMB-001C’s potential to help the large number of cocaine-dependent patients who currently have no effective therapies to help them break free.”
Embera’s technology has also demonstrated preclinical proof of concept in animal models for methamphetamine and nicotine dependence. The combination drug approach was developed by Embera’s Chief Scientific Officer, Dr. Nicholas Goeders, and represents an innovative and proprietary treatment paradigm for the illicit drug dependence field and other indications. Dr. Goeders explained: “As our dual mechanism broadly targets the craving associated with all addictions, we believe the drug combination may also prove useful in other dependence disorders such as nicotine in smoking cessation and alcohol dependence.”
Bob Linke, CEO of Embera, added: “The fact that EMB-001C is a proprietary combination of two off-patent, FDA-approved drugs, with a history of use in patients over decades, should positively impact the clinical development for this combination drug. The unmet medical need in cocaine dependence and the novel treatment paradigm of EMB-001C, we believe, can meet the Fast Track designation requirements of the FDA.”
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