(Photo caption: Pictured left to right – Ann Robbins, Ph.D. (bottom left), Gary Connor, R.N. (top left), Bob Linke, M.B.A., Michael Detke, M.D., Ph.D. (top right), Julie Ann Straub, Ph.D. (bottom right).)
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 via a novel approach addressing stress and its role in relapse for patients trying to quit. Today we’d like to introduce you to the company’s President and Chief Executive Officer, Bob Linke, and Chief Medical Officer, Mike Detke.
So, before we jump into specific questions about the business, why don’t you give us some details about you and your story.
Answered by CMO Mike Detke:
Professor Nicholas Goeders, Ph.D., from Louisiana State University Medical School in Shreveport, Louisiana, has been working on the stress hypothesis of addiction in his laboratory, funded by the National Institutes of Health (NIH), for over 30 years. It is the activation of the body’s stress response system that drives the underlying craving associated with all addictions that can result in relapse. A key insight he had was that two different drugs working on different systems might more effectively modulate stress, dampen cravings and help addicts stay abstinent, than any single drug. He tested many drug combinations on rats in his lab and found one that worked the best. Embera NeuroTherapeutics was founded in 2007 and since the two drugs (metyrapone and oxazepam) were already approved for human use in other diseases, a small human study was quickly conducted with promising results, showing that human cocaine addicts used less cocaine when treated with the above combination, which we’ve dubbed EMB-001.
Embera’s board of directors brought in Bob Linke as Chief Executive Officer, a seasoned biopharma executive that had previously led several development stage companies as CEO and worked in big pharma (Baxter International) after receiving his MBA from Harvard Business School. Bob recruited a group of experienced biopharma development experts and leading U.S. development partners to set the strategic course for the company to develop EMB-001, including the preclinical work to begin human testing. This work was also generously funded by the NIH, specifically from the National Institute on Drug Abuse (NIDA), with a $3.9M grant, after rigorous expert peer-review.
Bob expanded the team as EMB-001 reached human studies, hiring me, in 2016, as Chief Medical Officer. I have worked in pharmaceutical research for about 20 years, first at McLean Hospital here in the Boston area, followed by Eli Lilly, and a number of other small biotech companies prior to joining Embera 5 years ago. In June 2014, we filed the investigational new drug application (IND) for EMB-001, thereby receiving approval from the FDA to conduct further human studies, and we then commenced safety studies (Phase 1) to prepare for efficacy studies in Phase 2. Again, the studies for the treatment of cocaine addiction, for which there are no approved medications, was funded by an $11.1M grant from NIDA.
We are now ready to test the effectiveness of EMB-001 in Phase 2 studies in both tobacco (cigarette) addiction and cocaine addiction, upon the closing of the company’s next financing.
Overall, has it been relatively smooth? If not, what were some of the struggles along the way?
Answered by CEO Bob Linke:
10 to 20 years ago, most addiction treatment methods offered to patients were based on the 12-step method. Medication assisted therapies were generally not supported by the treatment community and had more limited, if any, reimbursement options from public and private insurance plans. When I joined Embera 8 years ago, much of the general public was not sure if addiction was really a disease that required treatment, or a character flaw that an individual needed to overcome. As a result, financing new treatments for addiction has been challenging.
The burden of addiction on our society continues to grow at a staggering rate. In 2017, 64,000 opioid overdose deaths were reported in the United States. To put this in context, that’s more than all US combat troops lost in Vietnam, or it’s about one airplane crash every single day. Since 2010, cocaine overdose deaths have more than doubled. 500,000 deaths occur each year as a result of smoking-related diseases that cost the U.S. an estimated $130B annually in medical costs alone.
The opioid crisis and its devastating effects on nearly every demographic in the U.S. population and, for many of us, our family, friends and colleagues, has shifted the general public’s belief and understanding of addiction. The Surgeon General’s 2016 Letter on addictions clearly supports the position that addiction is a disease that requires treatment.
Medication assisted therapies are being incorporated into the treatment regimens of leading addiction treatment centers, including the Betty Ford Clinic and the Mayo Clinic, who previously relied solely on cognitive behavioral therapy and 12-step programs.
Thanks to the Mental Health Parity Act and the Affordable Care Act, reimbursement plans for medication assisted therapies to treat addiction have been made available through most private insurance plans, Medicare and Medicaid.
We still have a long way to go to make up for the years that lacked both financial and scientific investments for the development of new addiction treatments. Embera has been very fortunate to receive significant support from NIDA ($15M in grant awards) for the development of EMB-001 for cocaine addiction. EMB-001 is currently the leading product in clinical development and could be the first product approved for cocaine addiction. To get there, we will need the support of both investors and pharma companies.
Alright – so let’s talk business. Tell us about Embera NeuroTherapeutics – what should we know?
Answered by CEO Bob Linke:
We have gathered a management team and development partners that are ideally positioned and focused to take drugs from late preclinical testing through Phase 2 clinical trials, essentially to see if they are safe and effective, and ultimately through Phase 3 trials and regulatory approval. More than 50% of the products in clinical development at large pharmaceutical companies come from companies like Embera who develop innovative products. As a result, a likely scenario with positive phase 2 data will be that Embera will license or sell its products to a pharmaceutical company who is seeking to bolster their late stage clinical pipeline and commercial organization with new products.
Our 6-person management team has an outstanding academic and industry resume, with well over 120 years of combined drug development and commercialization experience.
To advance EMB-001 in clinical development, we have partnered with leading U.S. biopharmaceutical development companies to further leverage their drug development expertise and utilize Embera’s development capital (from both investors and the NIH) as efficiently as possible.
We are the only company to our knowledge developing products based on the novel mechanism of modulating the stress response in addiction, that could bring a new and complimentary treatment paradigm to the addiction field and, most importantly, help those suffering from addiction.
How do you, personally, define success? What’s your criteria, the markers you’re looking out for, etc?
Answered by CMO Mike Detke:
At Embera, we measure success by the positive impact on patients, families and loved ones – lives saved and improved. Addiction takes an enormous toll on society as a whole, including patients, families, friends, and our healthcare system. I practice psychiatry part-time, so I periodically see and engage with patients who are suffering from addiction, and while there is no way to quantify the impact addiction has on the lives of these patients and their families, it is estimated that drug addiction costs the United States $700B annually. If we can bring a new, effective treatment to help those suffering from addiction, other measures of success will all be very positive.
Contact Info:
- Address: 365 Boston Post Road, Suite 210, Sudbury, MA 01776
- Website: https://emberaneuro.com/
- Phone: (978) 579-4156
- Email: info@emberaneuro.com
Chief Medical Officer of Embera, Mike Detke.
President and Chief Executive Officer of Embera, Bob Linke
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