Pα+ Psychedelic Bulletin #221: Helus Reports Murky Phase 2a Results; AtaiBeckley Says R-MDMA Met Safety Goal in SAD, Details Phase 3 Design for 5-MeO-DMT in TRD; Psilocybin for Smoking Cessation Study Published

Helus Reports Murky Phase 2a GAD Results for Deuterated DMT Analog

Last Thursday, Helus Pharma (formerly Cybin) quietly announced topline results from its Phase 2 study (n=36) of its intramuscular (IM) deuterated DMT analog (HLP004) in generalised anxiety disorder (GAD).

As a reminder, participants received two doses of either 20 mg or 2 mg of the study drug three weeks apart, as an adjunct to standard of care treatments. (It is currently unclear what non-study interventions participants were receiving, but Helus Chief Medical Officer Amir Inamdar told Psychedelic Alpha that participants on existing anti-anxiety medications remained on them throughout, and psychological support based on its ‘EMBARK’ model was provided.)

The press release was confusing. While the company reported a statistically significant and clinically meaningful improvement in the 20 mg group on the HAM-A scale of around 10 points on top of standard of care at week 6, this was compared to the group’s baseline, rather than a comparison to the 2 mg group. The only high-level comparison between the two arms provided by Helus in its initial release suggested...