Awakn Designates Program AWKN-002 for Alcohol Use Disorders in the US Market

Toronto, Canada – January 24, 2024 - Awakn Life Sciences Corp. (Cboe CA: AWKN, OTCQB: AWKNF, FSE: 954) (“Awakn”), a clinical-stage biotechnology company developing medication-assisted treatments for addiction with a near-term focus on Alcohol Use Disorder (“AUD”), is pleased to announce that it has successfully completed an investigative study to establish the dissociative effect of a proprietary and patent pending S-ketamine formulation, administered sublingually via an oral thin film (“OTF”).

Today’s news builds on Awakn’s announcement on December 20, 2023 of a global licensing agreement with LTS Lohmann Therapie-Systeme AG ("LTS"), a leading pharmaceutical technology company. The agreement was for a proprietary and patent pending S-ketamine OTF, with global exclusivity in the treatment of Addiction, Anxiety Disorders, and Eating Disorders. LTS has successfully completed a Phase 1 (“Ph1”) clinical trial and filed patents in the US and key international markets of China, Europe, and Japan for the S-ketamine OTF. Under the terms of the license, Awakn has secured access to this Ph1 data and patents thereby ensuring strong intellectual property protection and potential to rapidly progress to late clinical stage trials.

The mechanistic study, comprising 28 people who were harmful drinkers, investigated the impact of a single dose of the S-ketamine OTF on dissociation and alcohol cravings. The S-ketamine OTF was well-tolerated by all participants, with no reports of serious adverse effects. The S-ketamine OTF exhibited significantly greater dissociative effects than placebo, which were of a magnitude observed with doses of intravenous racemic ketamine given in clinical treatment.  the S-ketamine OTF also demonstrated a statistically significant reduction in alcohol cravings in participants compared to placebo.

Following the successful completion of the investigative study and the signing of the license agreement with LTS, Awakn is pleased to designate this program AWKN-002, S-ketamine OTF plus manualized relapse prevention cognitive behavioural therapy (“CBT”)  for  AUD. AWKN-002 is focusing on the US market, with Awakn planning a pre-IND meeting with the U.S. Food and Drug Administration (“FDA”) during the first half of 2024.

AWKN-002 will be complimented by Awakn’s existing AWKN-001 program ,intravenous (“IV”) racemic ketamine plus manualized relapse prevention CBT  for  Severe AUD, which will now focus on the UK market only.

Prof. Celia Morgan, the principal Investigator on the study commented “The rapid onset and offset of action of AWKN-002 and the ease of clinical use that we observed in our investigative study, compared to IV ketamine has galvanized our view that this represents a way to dramatically widen access to ketamine treatment. AWKN-002 means that we may reach more of the patients that desperately need this life-saving addiction treatment”. 

The Company has granted a total of 496,666 deferred share units (“DSUs”) and 993,334  restricted share units (“RSUs“) to certain directors, officers, employees and consultants of the Company in accordance with the Company’s Omnibus Long-Term Incentive Plan. The RSUs will vest in two stages, with 50% vesting on the date that is one year from the date of grant, and the remaining 50% vesting on the date that is two years from the date of grant. Each DSU and, once vested, each RSU, represents the right to receive one common share of the Company.

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a clinical-stage biotechnology company developing medication-assisted treatments for addiction. Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting approximately 51 million people in the US and key European markets and 285 million people globally for which the current standard of care is inadequate. Our goal is to provide breakthrough therapeutics to addiction sufferers in desperate need and our strategy is focused on commercializing our R&D pipeline across multiple channels. | Twitter | LinkedIn 

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Anthony Tennyson, CEO, Awakn Life Sciences