Healthcare Co.’s Psychedelic-Assisted Treatments Have ‘Blockbuster Drug Potential’

Source: Patrick Trucchio   07/15/2022

Psychedelic-assisted therapy has shown in a clinical trial that it can help patients with alcohol use disorder (AUD) or alcoholism. One company hopes to bring its treatments to clinics throughout Europe and become the go-to standard of care for AUD.

H.C. Wainright & Co. Analyst Patrick Trucchio initiated coverage on Awakn Life Sciences Corp. (AWKN:NEO; AWKNF:OTCQB), a biotechnology company that is advancing methylenedioxymethamphetamine (MDMA)-assisted therapy for alcohol use disorder (AUD) in Europe.

“We estimate (that MDMA-assisted therapy) could have blockbuster drug potential based on the significant unmet medical need and evidence generated to-date pointing to the potential of MDMA-assisted therapy in a variety of mood disorders,” Trucchio stated.

“Moreover, Awakn’s MDMA-assisted therapy has generated promising Phase 2a data in AUD, which follows the validation of the approach in PTSD in a late-stage program being conducted by MAPS, a non-profit organization based in the U.S.,” Trucchio added.

Awakn’s R&D efforts are focused on continued research related to ketamine-assisted and MDMA-assisted psychotherapy, at least initially.

“We estimate (that MDMA-assisted therapy) could have blockbuster drug potential based on the significant unmet medical need.”

— H.C. Wainwright & Co. Analyst Patrick Trucchio

In March 2021, Awakn acquired an exclusive license to the Phase 2 trial — the Ketamine for Reduction of Alcohol Relapse (KARE) study — from the University of Exeter in the U.K.

The KARE treatment is to be delivered in Awakn clinics in the U.K. Awakn has signed a Memorandum of Understanding with the National Healthcare Service (NHS), the U.K. healthcare regulator, and the University of Exeter, to assess options for bringing the KARE therapy into a Phase 3 program.

Separately, Trucchio notes that in March 2021 “Awakn acquired five years of know-how and research data from Equasy Enterprises, which is led by long-time psychedelic researcher David Nutt, (the data) has provided Awakn with access to details of potentially newly discovered modes of action for MDMA as well as details of potential faster acting entactogen-like compounds.”

Six months after that Awakn acquired the exclusive rights to MDMA-assisted therapies from Imperial College London which conducted a “successful Phase 2a. trial evaluating MDMA-assisted therapy in AUD.”

MDMA, also known as “ecstasy” and classified as a Schedule 1 drug (meaning it is illegal in the U.S.) since 1985, is a phenethylamine that raises levels of monoamine neurotransmitters in the brain.

Trucchio noted that “MDMA elevates mood, increases sociability and feelings of closeness to others, and can facilitate imagination and memory; evidence from neuroimaging studies shows a decrease in amygdala/hippocampus activity and an association between reduced amygdala activity and improved ability to process negative memories. Together with changes in social cognition, interpersonal closeness and communication, these data support the proposition that MDMA could be of benefit as an adjunctive psychotherapeutic treatment for alcohol addiction and co-morbid psychological disorders.”

In MDMA-assisted therapy studies conducted in post-traumatic stress disorder, on average, participants were drinking 130.6 units of alcohol per week in the month before detoxification, no units at the point of detox, and 18.7 units per week at nine months, implying a reduction of around 86% at nine months as compared to the average consumption one month prior to detox.

Awakn is building out a clinics network capable of delivering evidence-backed, psychedelic drug-assisted therapies for addiction and other mental health conditions in clinics in the U.K., and other European countries. As part of this build out, Awakn is also pursuing licensing partnerships of addiction treatments beyond the U.K. and Europe.

H.C. Wainwright & Co. has a Buy rating and a CA$10 per share price target on Awakn. The current share price is around CA$0.78.

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1) Brian Sylvester wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. They or members of their household own securities of the following companies mentioned in the article: None. They or members of their household are paid by the following companies mentioned in this article: None.

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Disclosures for H.C. Wainwright & Co., Awakn Life Sciences Corp., February 1, 2022

None of the research analysts or the research analyst’s household has a financial interest in the securities of AWAKN Life Sciences Corp, Atai Life Sciences N.V., Field Trip Health Ltd. and Mind Medicine (MindMed) Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of January 31, 2022 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of AWAKN Life Sciences Corp, Atai Life Sciences N.V., Field Trip Health Ltd. and Mind Medicine (MindMed) Inc.. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.

I, Patrick R. Trucchio, CFA , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The firm or its affiliates received compensation from Atai Life Sciences N.V., Field Trip Health Ltd. and Mind Medicine (MindMed) Inc. for non-investment banking services in the previous 12 months.

The Firm or its affiliates did not receive compensation from AWAKN Life Sciences Corp, Atai Life Sciences N.V., Field Trip Health Ltd. and Mind Medicine (MindMed) Inc. for investment banking services within 12 months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. The Firm does not make a market in AWAKN Life Sciences Corp, Atai Life Sciences N.V., Field Trip Health Ltd. and Mind Medicine (MindMed) Inc. as of the date of this research report.

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