DemeRx IB, an atai Life Sciences (atai) platform company focused on developing ibogaine for the treatment of opioid use disorder (OUD), announced the company has approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to commence subject enrollment in a Phase 1/2a clinical trial of ibogaine HCl (DMX-1002).

The Phase 1 portion of the MHRA approved trial will be conducted at the Manchester clinical unit of MAC Clinical Research (MAC), one of Europe's largest clinical development organizations. MAC's extensive good clinical practice experience, expertise and infrastructure will provide a platform for what is hoped to be a successful and significant trial.

"Our clinical trial authorization is a critical milestone," said Dr. Deborah Mash, CEO and President of DemeRx. "Stage 1 of the study will provide assessment of safety through the evaluation of ibogaine's potential adverse effects before we move to the proof-of-concept efficacy portion of our study in patients who seek to detoxify from opioids.”

"This approval allows DemeRx to progress clinical research beyond the previously published uncontrolled studies with ibogaine into well-designed, controlled studies in support of regulatory processes," said Srinivas Rao, Chief Scientific Officer and Co-founder of atai Life Sciences. "With the initiation of this trial, we start a journey towards understanding the potential of DMX-1002, in-line with regulatory bodies. We are optimistic for the future of DMX-1002 in treating OUD – this is a great step forward for DemeRx."

"Timing could not be more important as the world faces an ever-growing opioid epidemic. Current treatment options are not highly effective; approximately 75% of patients undergoing OUD therapy experience relapse within one year of treatment," said Florian Brand, Chief Executive Officer and Co-founder of atai Life Sciences. "This approval allows DemeRx to initiate this well-designed protocol to advance our understanding of how DMX-1002 may provide patients with a potentially transformative therapy, where currently the industry has developed few treatment solutions."

The approval for a Phase 1/2a clinical trial will enable DemeRx to study DMX-1002 in recreational drug users before the start of Stage 2 in opioid-dependent patients. Before the start of Stage 2, the trial will pause to allow MHRA to review human safety data together with nonclinical study results.