Psychedelic Treatment for Depression Moving Toward Clinical Trials
January 25th, 2022
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Depression, or more formally Major Depressive Disorder (MDD), is a widespread and growing problem across the globe. In the United States in 2019, 19.4 million adults (7.8% of all adults) were estimated to have a major depressive episode. About two-thirds of these people received treatment of some sort, and the most effective treatments produce roughly 30 to 40 percent remission rates. As a result of the pandemic and related stresses, prevalence of depressive symptoms in US adults shot up to a staggering 27.8% in 2020, and 32.8% in 2021.
The opportunity is enormous for those able to develop better forms of treatment for MDD. Axsome Therapeutics’ (NASDAQ: AXSM) lead drug candidate, AXS-05, showed 52.5% remission after 6 weeks of treatment and even higher rates with longer treatment periods. In 2020, the company estimated peak sales of AXS-05 for the treatment of MDD could range from $1 billion to $3 billion annually. AXS-05 has been awaiting FDA approval since August, 2021.
Meanwhile, psychedelic therapies for MDD have shown great promise. A quick search of the Internet will reveal that much. But there are major barriers to approval and widespread acceptance of these therapies. First, many of the drugs are Schedule 1 substances subject to strict federal regulation. Second, many of them involve intense hallucinogenic experiences that make many people hesitant to try them while requiring a long period of clinical supervision during treatment. Third, most psychedelic substances are in the public domain and can’t be patented, meaning that companies may not be motivated to spend the money and time necessary to bring them through trials and to the market.
BetterLife Pharma Inc. (CSE: BETR) (OTCQB: BETRF) (FRA: NPAU) has developed a drug candidate that may be a viable alternative for the treatment of neuro-psychiatric and neurological disorders. BetterLife’s BETR-001 is a synthesized derivative of LSD that demonstrates the benefits of its ‘parent’ but without the hallucinogenic side effects and regulatory hurdles possible with other psychedelic compounds. BetterLife has applied for a comprehensive patent, and recent developments show the company proceeding through preclinical studies to an anticipated Phase 1 trial in Q3 2022.
Recent Developments Promising
BetterLife Pharma recently announced two positive developments for the advancement of BETR-001. First, the company obtained good results from its preclinical work that was focused on bioavailability and the effect food would have on the uptake of the drug. Results showed the presence of food, or the lack thereof, did not significantly affect bioavailability, with systemic circulation of the drug reported around 60%. Importantly, maximum concentration was reached around 30 minutes after administration indicating quick uptake. On the other end, the drug was shown to leave the system at a consistent rate, suggesting that drug accumulation and possible toxicity are not likely.
“We are very pleased with the results of the first oral PK study for BETR-001 drug manufactured by BetterLife’s patented synthesis and formulation process. Although 2-bromo-LSD has been tested in rodents and human studies in the past, this is the first study to characterize its PK profile in vivo”, stated BetterLife’s Chief Executive Officer, Dr. Ahmad Doroudian. He added, “These data, together with the ongoing IND-enabling nonclinical toxicology studies, will support the filing of BETR-001’s IND application with the FDA and initiation of human clinical trials in H2 2022.”
In the second bit of news, BetterLife announced generally positive feedback from its pre-investigational new drug (pre-IND) meeting with the FDA. The pre-IND process helps the company prepare its IND filing, necessary for the initiation of clinical trials, and gives the FDA a look at the company’s plans for the drug.
CEO Dr. Ahmad Doroudian stated, “The response from the FDA confirms that our current program will support the filing of BETR-001’s IND application and initiation of human clinical trials by the third quarter of this year. Being a non-hallucinogenic derivative of LSD makes BETR-001 a unique molecule with therapeutic potential for the treatment of debilitating psychiatric and neurological disorders with high unmet need, such as major depressive disorders and cluster headaches. Our team is fully dedicated to start the human clinical trials in the United States by early second half of this year.”
There are several upcoming events and developments that could work as catalysts for BetterLife Pharma. More data will likely be announced prior to the company’s anticipated IND filing and commencement of clinical trials for BETR-001, targeted for Q3 2022. On top of the treatment for MDD discussed above, BetterLife is eyeing cluster headaches as another indication to be investigated in the trials.
The company is also looking for results from its Phase 2 inhalable interferon/COVID-19 trial in Chile. If the results there look good, BetterLife plans to move quickly into an IND application with the FDA in the United States that would set in motion a US-based Phase 2 trial of the promising treatment.
With the COVID and depression treatments taking center stage recently, BetterLife’s Interferon/HPV trial program has been tabled to an extent. Phase 2b trials will be the next step in this drug’s development. The company is exploring options to move both the HPV and COVID drugs, both based on interferon, into a new vehicle that could create significant shareholder value in the short term. Options range from partnering with other drug development companies to creating a subsidiary or separate entity entirely.
Overall, BetterLife Pharma represents a compelling opportunity in novel therapeutic development. It’s compounds are patentable improvements on naturally occurring substances with the potential to treat conditions like MDD, migraines, and even COVID-19. Stay tuned as BetterLife makes its way through this pivotal year in the company’s development.
BetterLife Pharma is focused on developing and commercializing compounds to treat neurological and neuro-psychiatric disorders as well as viral infections.
Interested readers are encouraged to contact the company via Manager of Investor Relations David Melles, at [email protected].
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