The article Awakn Life Sciences Granted Fast-Track Designation from UK for Ketamine Therapy was originally published on Microdose.

Awakn Life Sciences continues to advance its primary program forward, receiving continued support from UK regulators.

The company previously announced that its Phase 3 trial using ketamine for Alcohol Use Disorder is going ahead in several sites across the UK, in collaboration with the National Health Service (NHS). This is in addition to financial support from the UK government, as these trials will be partially funded by the government in the form of grants.

Now UK regulators have granted Awakn an Innovation Passport as part of the Innovative Licensing and Access Pathway (ILAP) for its proprietary ketamine-assisted therapy for the treatment of Severe Alcohol Use Disorder. Similar to the FDA’s fast-track program, this should accelerate Awakn’s path towards final regulatory approval.

See the full press release below.

Awakn Life Sciences Granted Fast-Track Designation from UK Regulator for Ketamine-Assisted Therapy for Alcohol Use Disorder

DESIGNATION AIMS TO ACCELERATE TIME TO MARKET

Toronto, Ontario–(Newsfile Corp. – February 7, 2023) – Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) (“Awakn”), a biotechnology company developing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announces today the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has granted Awakn an Innovation Passport as part of the Innovative Licensing and Access Pathway (ILAP) for its proprietary ketamine-assisted therapy for the treatment of Severe Alcohol Use Disorder.

Alcohol use disorders affect 285 million people globally, of these circa. 25% or 70m people suffer with Severe Alcohol Use Disorder.

ILAP aims to accelerate time to market, facilitating patient access. Similar to the FDA’s fast-track program in the United States, the U.K.’s MHRA Innovation Passport provides Awakn with access to specialist advice from the MHRA and its partners, including the National Institute of Health and Care Excellence (NICE). Throughout the therapeutic development process this has the potential to enable a more efficient, and ultimately a faster route to marketing authorization.

The ILAP provides a single integrated platform for sustained collaborative working among the MHRA, several key bodies and the therapeutics developer, allowing for earlier engagement, enhanced coordination and monitoring of important product development activities culminating in market authorisation. This also has the potential to allow the National Health Service (NHS) to adopt potential treatments faster and ultimately enable quicker patient access to these potential medicines. Under the ILAP, Awakn will have access to a toolkit to support all stages of the design, development, and approvals process, as well as identify key areas for future agency engagement.

Anthony Tennyson, Awakn CEO, commented, “Ensuring our therapeutics reach people who need them most is our key priority as a company. Having an innovation passport gives us the opportunity working with the regulators to find the most efficient pathway to marketing authorization and ultimately and most importantly to those people who desperately need it. We are very grateful to the MHRA and its partners for identifying the vast potential in our treatment.”

Professor Celia Morgan, Awakn’s Head of Ketamine-Assisted Therapy, added, “The award of Innovation Passport status validates development of our highly innovative therapeutic approach of using ketamine-assisted psychotherapy to treat severe alcohol use disorder and our desire to bring this therapeutic approach to patients as rapidly as possible. This will enable us to build optimally on the excellent phase II proof of concept study as we work in partnership towards marketing authorization. We look forward to working closely with the MHRA, NICE and partners to accelerate our planned phase 3 clinical trial, to be undertaken in collaboration with the NIHR, MRC, NHS, and Exeter University.”

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a biotechnology company developing therapeutics to treat addiction. Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting 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.

therapeutics
life sciences
healthcare
ketamine
therapy
psychotherapy
authorization
fda