atai Life Sciences has announced results from its Phase 1 Study of DMX-1002 (Ibogaine) for the treatment of opioid use disorder (OUD).
DMX-1002 is a cholinergic, glutamatergic and monoaminergic receptor modulator being developed for the treatment of OUD.
The single-blinded Phase 1 study assessed the safety, tolerability and pharmacokinetics of single-ascending doses of DMX-1002 in healthy volunteers. Oral doses of 3 mg/kg, 6 mg/kg & 9 mg/kg were evaluated in 20 participants.
Results showed that oral doses of DMX-1002 at 9 mg/kg achieved plasma concentrations in line with those described in previous studies in which subjects reported psychedelic experiences and obtained therapeutic benefits in OUD.
Treatment-related adverse events (AEs) were similar to those observed in prior trials of DMX-1002, and nearly all (>94%) were rated mild-to-moderate in severity, with no serious adverse events reported.
In one of the two participants who received 9 mg/kg of DMX-1002, QTc prolongation reached levels near those seen at the 10 mg/kg dose in the published literature. In this participant, a QTcF prolongation of 90-94ms was observed with a QTcF interval of 493-501ms. The patient was asymptomatic, with no cardiac arrythmias, and the QTc change resolved without intervention or sequalae.
During the study, the company closely worked with cardiology experts who concluded that while QT prolongation of this order is a clinical risk, monitoring can help mitigate the risk to ensure the safety of patients, especially in a medical setting.
The benefit of the drug will need to be defined in efficacy trials and will need to be weighed against the risks that have been defined.
The company plans to engage regulatory authorities to assess progressing DMX-1002 into an efficacy study in patients with OUD.
