Mr. Anthony Tennyson reports
AWAKN LIFE SCIENCES' PHASE III TRIAL APPROVED FOR APPROXIMATELY CA$2.5 MILLION FUNDING FROM UK STATE COVERING 66% OF COSTS
The National Institute for Health and Care Research (NIHR), a United Kingdom government agency, has approved grant funding for 66 per cent of the costs of Awakn Life Sciences Corp.'s phase 3 clinical trial exploring the use of ketamine-assisted therapy for the treatment of alcohol use disorder (AUD). The trial is currently forecast to cost approximately $3.75-million in total, with Awakn financing approximately $1.25-million of that.
The funding will support Awakn's lead clinical development program, Project Kestrel, which aims to deliver clear intellectual property (IP) and marketing authorization/regulatory approval for ketamine-assisted therapy to treat AUD in the U.K. and the United States.
The phase 3 trial is expected be the largest ketamine-assisted therapy clinical trial to date and the only phase 3 psychedelic clinical trial to receive government funding. Awakn will partner with the University of Exeter (UoE) and the U.K.'s National Health Service (NHS) to deliver the landmark trial. It is planned to be conducted across seven sites in the U.K., with the treatment being administered within the NHS infrastructure. The trial is currently designed to include 280 patients; they will be followed up over the course of six to 12 months. The trial will also pilot bespoke continuing peer support groups posttreatment.
The trial, which is targeted to be a pivotal trial, follows on from the ground-breaking results of Awakn's phase 2a/b trial announced in January, 2022, which resulted in AUD participants experiencing on average 86 per cent abstinence at six-months post treatment versus 2 per cent pretrial. The phase 3 trial will focus on establishing further definitive evidence of the efficacy of ketamine-assisted therapy for the treatment of AUD and to move toward the novel treatment being licensed for this indication. Awakn, UoE and the NHS will be working with the U.K. Department of Health and Social Care and other key stakeholders throughout the trial to facilitate the swift uptake within the NHS post trial, should the results be positive.
The phase 3 trial will be led by professor Celia Morgan, Awakn's head of ketamine-assisted therapy and professor of psychopharmacology at the University of Exeter.
Ms. Morgan commented: "It is a true honour to lead the team that will deliver this research. The trial represents a huge leap forward in the treatment of AUD. I know this will be a great source of hope for the patients we work with, their families and friends. The financial commitment by the U.K. government emphasises the promise of this treatment and the scientific rigour behind the trial. This, coupled with running the trial in the NHS settings and working closely with regulators throughout, means that the probability of quick adoption is very high, should the results of this trial fulfill their early promise."
Awakn selected AUD as its lead indication because it is a chronic disease constrained by a significant treatment gap, and a poor current standard of care. AUD affects 400 million people globally; with only 8 per cent of people with this disease seeking treatment, and typically a 75-per-cent relapse rate within 12 months among those who have. Despite this significant treatment gap and poor efficacy, the U.S. AUD treatment market is valued at $45-billion, while the NHS in the U.K. spends more than $5.5-billion a year on AUD related illness.
Anthony Tennyson, Awakn's chief executive officer, commented: "We are pleased with today's news for several reasons. A government showing such strong support for this new type of treatment is a global first. Secondly, working with the NHS to deliver the treatment in their existing infrastructure is a huge statement of intent, but most importantly, for so many millions of people around the world suffering from alcohol addiction, a new treatment hope has just got one big step closer. I could not be prouder of the Awakn team and our partners for making this a reality."
About Awakn Life Sciences Corp.
Awakn Life Sciences is a revenue-generating biotechnology company researching, developing and commercializing therapeutics to treat substance and behavioural addictions. Awakn has a near-term focus on alcohol use disorder (AUD), a condition affecting 400 million people globally for which the current standard of care is inadequate. The company's goal is to provide effective therapeutics to addiction sufferers in desperate need and the company's strategy is focused on commercializing the company's R&D (research and development) pipeline across multiple channels.
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