Welcome to the News You Might Have Missed, a weekly roundup of psychedelic medicine news to help you catch up and stay informed.
Atai Starts New Phase 1 Study of PCN-101 (R-Ketamine)
atai announced the start of a Phase 1 trial to evaluate the additional potential of its ketamine product in different delivery modes.
This IV-to-subcutaneous bridging study will potentially inform dosing regimens of the new subcutaneous formulation that may optimize PCN-101 in future studies, thereby supporting further exploration of the potential of R-ketamine as a rapid acting anti-depressant for at-home use. atai continues to work with Perception Neuroscience to explore strategic partnership options.
MindMed Announces Positive Data from Phase 2 LSD Trial for Depression
From Robert Barrow, Chief Executive Officer of MindMed: “The statistically and clinically significant improvements observed in this study reinforce preliminary findings that have shown the clinical potential of lysergide in anxiety, depression and other brain health disorders. These positive findings are particularly relevant to our MM-120 program in generalized anxiety disorder, given the high degree of comorbidity of GAD and MDD.”
Hawaii Passes Bill To Prepare For Federal Approval of Psychedelics
Psychedelic legislation is moving through the Aloha state. The Hawaii Senate has approved a bill HB1340
, a proposed law that would create an advisory board to explore and prepare for regulations around federal approval of “breakthrough therapies” like psychedelics.
Numinus Launches New Clinic Licensing Platform
Numinus has launched a new clinic licensing model, Numinus Network, offering independent practitioners the opportunity to own and operate their own clinic under the Numinus Wellness brand.
This model could provide practitioners with an alternate model, allowing them to retain ownership of their practice while leveraging Numinus patient protocols.
Nova Mentis Receives Institutional Review Board Approval to Commence Psilocybin Clinical Trial
Nova Mentis announced it has received institutional review board (IRB) approval in Canada to begin its human study testing the efficacy of psilocybin on adults diagnosed with fragile X syndrome (FXS), the leading genetic cause of autism spectrum disorder (ASD).
The Phase IIA clinical trial received the go-ahead from Health Canada in December of 2022 and is one of the first approved studies that will permit participants to take home the drug for dosing every other day. The Company plans to begin the recruitment process within the coming weeks.
