Mr. Anthony Tennyson reports
AWAKN LIFE SCIENCES SUBMITS CLINICAL TRIAL APPLICATION FOR PHASE III TRIAL OF AWKN-P001
Awakn Life Sciences Corp. has submitted the clinical trial application (CTA) for a phase III trial for its lead program AWKN-P001 for the treatment of severe alcohol use disorder (SAUD).
SAUD, the most acute type of alcohol use disorder, affects approx. 12.5 million people in the US and the key European markets of Germany, UK, France, Italy, and Spain.
AWKN-P001 is a novel combined therapeutic of an N-methyl-D-aspartate receptor-modulating drug (ketamine) used in combination with psycho-social support to treat SAUD. Results from AWKN-P001 phase II study were positive, achieving 86% abstinence in the 6 months post treatments vs. 2% abstinence pre-trial and 25% abstinence in current standard of care.
The trial is being run by Awakn, The University of Exeter, and a partnership between the National Institute of Heath and Care Research (NIHR) and the Medical Research Council (MRC). The phase III trial will be an n=280, two-armed randomized placebo-controlled trial. It will be delivered in the UK across ten UK National Health Service (NHS) sites. Awakn will contribute approx. GBP pounds sterling800,000 towards the costs of the trial, with the NIHR, the MRC, and the University of Exeter contributing the balance of the costs.
Awakn and its partners are expecting feedback in the coming months on the CTA, and subject to ethical and regulatory approval, first trial participants will be treated in late Q4 2023 or early Q1 2024.
Furthermore, in February 2023 UK Medicines and Healthcare products Regulatory Agency (MHRA) awarded an Innovation Passport to AWKN-P001. The Innovation Passport is the entry point for the MHRA's Innovative Licensing and Access Pathway (ILAP), the UK's version of the FDA break through designation. The goal of ILAP is to accelerate the time to market in the U.K. Awakn now intends to utilize its ILAP access to seek input from the regulators including the MHRA and the National Institute of Health and Care Excellence (NICE) regarding market access for AWKN-P001 in the UK.
Anthony Tennyson, Awakn CEO commented, "We are pleased to be working with our partners in the NIHR, MRC, and the University of Exter on this program as we together progress AWKN-P001 closer to potentially treating the first participant in the phase III trial. We are also pleased to have secured ILAP designation for AWKN-P001 with which we will look to initiate discussions in the near-term with the MHRA and NICE on our target development plan and market access in parallel to the executing the phase III."
About Awakn Life Sciences Corp.
Awakn Life Sciences Corp. is a clinical-stage biotechnology company developing therapeutics targeting addiction. Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting 40 million people in the US and key international markets and 285m 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.
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