Awakn Life Sciences Corp., (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) (Awakn) a biotechnology company developing and delivering psychedelic therapeutics to treat addiction, announced today that it has acquired the exclusive rights to the data from the phase IIa Bristol Imperial MDMA in Alcoholism Study (BIMA) from Imperial College London, which has one of the world’s leading psychedelics research centers.
BIMA was an Open-label safety, tolerability, and proof-of-concept study to investigate the role of MDMA-Assisted Psychotherapy in treating patients with alcohol use disorder (AUD). It was the first published study assessing MDMA-Assisted Psychotherapy as a treatment for addiction. The results which were published in February 2021, indicated that MDMA has the potential to be more effective at treating AUD. With a 20% relapse rate within the first nine months, compared to a 75% relapse rate with traditional treatments.
This data will assist Awakn’s progress by enabling a better design and more efficient execution of its clinical program. Awakn will now be able to accelerate its clinical research into a phase IIb randomized controlled trial (RCT) in the U.K. This is part of its strategy to secure marketing authorization for MDMA to treat AUD in both the U.K. and the European Union, a 400 million person territory.
“Drinking behavior outcomes from the BIMA phase IIa study that Awakn just acquired indicates that MDMA has the potential to be more effective at treating AUD, with only a 20% relapse rate within the first nine months. This compares very favorably with the current best available traditional treatments for patients post-detox with AUD,” said Dr. Ben Sessa, Chief Medical Officer of Awakn and the principal investigator of the BIMA study.
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He continued, “This data acquisition is an important step along Awakn’s path to providing lifesaving MDMA treatment to the millions of people currently suffering with AUD, offering better outcomes without the exorbitant rates of relapse.”
AUD is a serious and currently poorly treated disorder, affecting 5% of the global adult population. Treatment of AUD rates is low at 16%.
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Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include: whether conditions to the listing on NEO will be satisfied; the business plans and strategies of the Company, the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; inconsistent public opinion and perception regarding the medical use of psychedelic drugs; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.
Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company’s public filings on SEDAR at www.sedar.com. The Company disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events, or otherwise, other than as required by law.
This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States. The Company’s and Awakn’s securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.
Source: Biospace
