Toronto-based Awakn Life Sciences Corp. (OTC: AWKNF) received approval for a Phase III clinical trial in the United Kingdom for its lead treatment candidate, AWKN-P001, targeting severe alcohol use disorder.
According to a statement, U.K.’s Medicines and Healthcare Products Regulatory Agency and the Health Research Authority approved the trial, with funding support from both Awakn and the National Institute for Health Research Efficacy and Mechanism Evaluation Programme. According to previous reporting, the U.K. government will cover most of the trial costs, leaving Awakn to contribute only $1.25 million.
Awakn also said it completed a feasibility study for a proprietary formulation of MDMA, using Catalent‘s Zydis orally disintegrating tablet technology, which the company has high hopes for. That study assessed the stability of MDMA in the new delivery format, which could offer an alternative method of administration for such treatments and shorten therapy sessions.
To address market access, Awakn said it partnered with Orphan Insight Ltd., which provides consulting on bringing novel drug therapies to market. The two will collaborate on developing strategies to “advance market access, pricing, and reimbursement” for AWKN-P001 in various key markets, including the U.S. and several European countries.
The company also embarked on a non-brokered private placement financing in April 2023, initially seeking to raise $3 million, which was later increased to $4 million.
The latest tranche of that financing raised $230,000, bringing the total to $2.96 million.
The completion of the offering is subject to receiving the necessary corporate and regulatory approvals, including approval from the NEO Exchange.