Psychedelics Briefs: MindMed, Numinus Wellness

MindMed, the clinical-stage biopharmaceutical firm that is developing psychedelic therapies to treat mental health conditions and addiction, announced that it has enrolled the first subject into its Session Monitoring System (SMS-01) study to evaluate the passive collection of sensory data during a conscious-altering therapeutic session. The company said in a release it believes the system could have therapeutic applications in the treatment of psychiatric disorders.

"The launch of this study is an important milestone for MindMed and for the future development of regulated devices and software-as-medical-devices (SaMD) products designed to support novel analyses of multimodal data in the delivery of psychiatric care,” Daniel R. Karlin, MD, MA, chief medical officer of MindMed, said in a news release.

“By refining the techniques used to capture, model and map these outputs, we aim to improve the experience of clinicians and outcomes for patients in the delivery of psychedelic and other perception-altering substances."

Numinus Wellness Receives Approvals for Study

Numinus Wellness announced this week that it has completed several regulatory steps in preparation of enrolling participants in a multi-site, open-label extension study of MDMA-assisted psychotherapy for post-traumatic stress disorder (PTSD). The study is being sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS). The study’s sites have received regulatory authorization from Health Canada, ethical approval from an Institutional Review Board (IRB), and a Section 56 exemption from Canada’s Controlled Drug and Substance Act, allowing the use of MDMA throughout the clinical trial.

Numinus will host Canadian sites for the study, managed through 2 clinics it recently acquired. The trial will be open to eligible participants who previously were enrolled in the placebo arm of the parent study or who were not able to receive treatment because of COVID-19-related restrictions.

References

MindMed enrolls first participant in study of its Session Monitoring System. News release. MindMed; January 18, 2022. Accessed January 19, 2022.

Numinus announces key milestones in MAPS-sponsored MDMA-assisted therapy for PTSD clinical trial. News release. Numinus Wellness Inc.; January 19, 2022. Accessed January 20, 2022.