The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the launch of a Phase I/IIa trial of DemeRx and atai Life Sciences’ ibogaine HCl (DMX-1002) for the treatment of opioid use disorder (OUD).
The approval will enable DemeRx to evaluate ibogaine HCl in recreational drug users before the start of stage 2 in opioid-dependent patients.
Prior to the launch of stage 2, the trial will pause to allow the MHRA to review human safety data along with non-clinical study results.
The Phase I portion of the trial will be conducted at the Manchester clinical unit of MAC Clinical Research.
“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,” added Rao.