Zynerba Failure Highlights the Need for Expertise, Broader Portfolios
August 15, 2017 11:41 am ET
Zynerba Pharmaceuticals Inc. (NASDAQ: ZYNE) shares were cut in half after a Phase II clinical trial of its transdermal cannabidiol (“CBD”) gel patch missed all of its endpoints.
The clinical study of 188 adults with refractory epilepsy found that those taking a low dose of ZYN002 experienced an 18.4% median reduction in seizures compared to a 14.0% reduction for high dosages and an 8.7% reduction for placebo. The endpoint missed and the lack of a dose-dependent response suggest that the underlying delivery system was ineffective. The therapeutic also failed to beat placebo in any of the secondary goals.
In this article, we will look at some takeaway lessons for investors in the cannabis biopharmaceutical industry and why AXIM Biotechnologies Inc. (OTCQB: AXIM) may be an attractive opportunity.
Learning from Failure
Zynerba’s clinical trial failure underscores several key points that cannabis investors may want to carefully consider when choosing their next investments.
First, investors should exercise caution when investing in companies with small clinical pipelines. Zynerba’s only other clinical program is ZYN001, which is a THC prodrug patch that has yet to clear Phase I clinical trials, which means that the failure of ZYN002 in Phase II clinical trials took a significant toll on the stock price. Investors should seek out companies with broad portfolios where a single failure won’t jeopardize the entire company.
Second, working with cannabinoids may be more difficult than many companies and researchers had initially thought. Cannabinoids have complex interactions with the human body and don’t always behave as researchers would expect. Investors should look for companies that have deep expertise in medicine, as well as positive signs of efficacy in earlier Phase I and pre-clinical trials to maximize their odds of success.
Third, it may be tempting to assume that cannabinoids have been over-hyped following Zynerba’s failure, but investors shouldn’t give up on the space. Zynerba’s clinical trial did show that CBD is safe and well-tolerated, while GW Pharmaceuticals plc’s (NASDAQ: GWPH) clinical programs have confirmed the both THC and CBD have broad promise in treating underlying conditions - it’s a matter of effectively delivering the molecules in the right dosages.
Taking a Diverse Approach
George Anastassov, MD, DDS, MBA, leads the company with over three decades of experience in the research and development of pharmaceutical and biotechnology products. Dr. Anastassov is joined by Dr. Philip Van Damme, DMD, MD, PhD, and Dr. Lekhram Gangoer, MSC, BSC, who have similarly strong backgrounds in the pharmaceutical and biotechnology industries. This team is well-qualified to lead the company’s clinical programs through approvals.
The company has already formulated over 20 diversified products covered by 17 patents and 20 trademarks with several nutraceutical products on the market in over 40 countries. Its lead products include MedChew Rx® which is currently undergoing clinical trials for the treatment of pain and spasticity in Multiple Sclerosis, CanChew+® which is set to finish its Phase II clinical trial for the treatment of Irritable Bowel Syndrome (IBS) by the end of this summer and was recently featured on CBS, and AX-1602 which is currently being researched for treatment of Psoriasis and Atopic Dermatitis and was covered by Forbes, although it has many other programs in the pipeline.
In addition to these programs, AXIM has shown recent additional diversification to its robust clinical pipeline by announcing pre-clinical research and Contract Research Organization (CRO) contracts on programs for treatment of Restless Leg Syndrome (RSL), drug-induced psychosis, and a reformulation of FDA-approved Marinol(R) for treatment of nausea and vomiting in cancer and AIDS patients as reported by Forbes.
As a matter of proof of AXIM’s forward thinking mentality, AXIM recently announced that it had filed a patent on a combining Opioid Antagonists and Cannabinoids as covered by Reuters. AXIM intends to create a product that would treat opioid addicts by leveraging a small dose of opioid antagonist to react with the body's opioid receptors while providing the perceived pain relief properties of cannabinoids in one prescription drug. Although unproven at the moment, validation of their theory would render a product able to treat the estimated 1 in 3 americans who are dealing with opioid addictions.
Most of AXIM’s clinical programs utilize its proprietary micro-encapsulated chewing gum delivery technology. Its flagship chewing gum delivery system not only effectively delivers active ingredients, but also conveys other benefits like improved cerebral circulation, stimulation of the basal ganglia, and improved neuroprotection and analgesic effects, among other things.
AXIM Biotechnologies (OTCQB: AXIM) represents a compelling investment opportunity in the cannabis industry given its diverse clinical pipeline and strong management team. After Zynerba’s failure, cannabis investors may want to look into these kinds of companies to avoid facing the same kinds of issues as the industry matures.