Numinus Wellness’ (NUMI.V) compassionate-access trial for MDMA-assisted therapy has enjoyed some success in terms of treating patients with post-traumatic stress disorder (PTSD), according to a press release.
The trial is a collaboration between NUMI and Multidisciplinary Association for Psychedelic Studies (MAPS) subsidiary MAPS Public Benefit. MAPS is a developer of treatment protocols, research, and MDMA-assisted therapy training sessions.
“We are excited to share an update on the progress of our MDMA compassionate access trial with the full recognition that existing therapies for PTSD are inadequate. At Numinus, we are pleased to help foster a promising regulatory landscape that will contribute to a better understanding that psychedelic-assisted psychotherapies are a viable, safe, and necessary avenue for expanding existing treatment options. We look forward to continued collaboration with the Multidisciplinary Association of Psychedelics for Studies (MAPS PBC) and will work together to provide those experiencing PTSD with more treatment options,” said Payton Nyquvest, CEO of Numinus.
The trial has advanced into the pre-implementation stage at Numinus’ Vancouver clinic after passing pre-set milestones, including recruitment of therapists, physicians and staff to handle participant enrolment and analysis of therapy outcomes. The newly arranged assortment of medical personnel will collect safety data for Health Canada to advance research into PTSD that helps suffers who haven’t seen any benefits from existing treatment.
A draft protocol for treating PTSD using MDMA has been adapted for the trial, including guidance about screening processes for health histories, indications and potential contraindications before accepting participants. The company has successfully passed through initial regulatory meetings put on by Health Canada, and the next steps include getting ethical and Health Canada approvals for actual participant recruitment according to COVID-19 public health protocols.
Eight Numinus therapists graduated from Part B of the MAPS MDMA therapists training program in November, and will immediately complete the supervision requirement to get certified as fully qualified MDMA therapists.
Shares of Numinus are up $0.02 today, closing at $1.74.