Awakn Life Sciences has submitted a clinical trial application to investigate the use of AWKN-P001 – a novel combined therapeutic of an N-methyl-D-aspartate receptor-modulating drug (ketamine) – used in combination with psycho-social support to treat Severe Alcohol Use Disorder (SAUD).
Awakn has submitted the Clinical Trial Application (CTA) for a Phase III trial for its lead programme AWKN-P001.
SAUD is the most acute type of alcohol use disorder, affecting approximately 12.5 million people in the US and Germany, UK, France, Italy and Spain.
Results from AWKN-P001 Phase II study have shown 86% abstinence in the six months post treatments compared to 2% abstinence pre-trial, and 25% abstinence in current standard of care.
The n=280, two-armed randomized placebo-controlled trial is being run by Awakn, The University of Exeter, and a partnership between the National Institute of Health and Care Research (NIHR) and the Medical Research Council, and will be delivered in the UK across ten UK National Health Service (NHS) sites.
In February 2023, the 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 breakthrough designation.
The ILAP scheme aims to accelerate the time to market in the UK for medicines, and 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.
Awakn CEO Anthony Tennyson commented: “We are pleased to be working with our partners in the NIHR, MRC, and the University of Exeter on this programme 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 Phase III.”
Awakn will contribute approximately £800,000 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.
