🎉 Health Canada Provides a No Objection Letter for ATMA’s N500 Phase II Clinical Trial Application

Fourteen healthy subjects completed an experiential session after receiving 25 mg psilocybin  – Results of this phase I study will inform the design of Phase II study in frontline healthcare workers, examining the efficacy of psilocybin for Covid-related stress.

 

Calgary, September 7, 2022 — ATMA Journey Centers (the “Company”), a company providing therapist training and support, has completed the experiential portion of its Phase I clinical trial with mental health care providers as the participants. Filament Health’s psilocybin product, developed for the treatment of mental health and addiction indications, was used in the trial. The final results from the trial are expected to be published in late Fall 2022.

“This is an exciting milestone, and we look forward to publishing the results of our Phase I study in the coming months,” said David Harder, Chief Executive Officer of ATMA. “The growing mental health crisis has become a pandemic in its own right, and being part of the movement to demonstrate the safety of psilocybin in a clinical setting is an important step in collecting the data necessary to move onto larger trials that assess efficacy.”

 

ATMA’s Phase 1 Trial Design

In order for psilocybin to be administered safely in a clinical setting, more baseline physiological, psychological, and observational data is required from healthy individuals. ATMA’s Phase I, single dose trial was conducted at the Newly Institute in Calgary, Alberta. Under observation from Dr. Ravinder Bains, ATMA’s Chief Medical Officer, and Dr. Lyle Galloway, ATMA’s medical consultant and palliative care specialist, participants received a 25mg dose of naturally extracted psilocybin. As per the trial’s primary objective, safety and tolerability were assessed by monitoring vital signs including blood pressure, heart rate, and temperature, as well as electrocardiogram (ECG) readings. After the first five participants consumed psilocybin, data was collected and reviewed by the trial’s Data Safety and Monitoring Committee (DSMC). Based on the absence of serious adverse events, this team of physicians gave ATMA the ‘green light’ to proceed with the administration of psilocybin to the remaining participants.

The secondary objective of the trial, which will be examined over the next eight weeks, will assess the psychological outcome of consuming a single dose of psilocybin, including changes in both perception and mood via the Mystical Experience Questionnaire (MEQ-30) and the Quick Inventory of Depressive Symptomatology (QIDS-SR16), respectively. Any adverse events occurring during this period will also be documented.

“Our goal is to complete this trial with the highest standards of scientific rigor, and to gather data to inform how to best proceed with future trials,” states ATMA’s Chief Scientific Officer Dr. Michael Blough. “Between highly dedicated members from the ATMA staff and a team of excellent physicians, this will be achieved.”

Over the next eight weeks, the clinical trial team will remain in regular contact with the participants to ensure their physiological and psychological well-being. “Based on the literature, we do not expect any long-term adverse or serious adverse events,” explains Dr. Bains. “However, it will be nice to be able to state this conclusively with the data in hand.”

In addition to the primary and secondary objectives, this trial also provided healthcare providers the unique opportunity to experience the physiological and psychological effects of psilocybin. “With psilocybin-assisted therapy becoming a real-world possibility, we feel it is critical for mental health care providers to understand this medicine, not just from a biological perspective, but also the experience itself,” comments Dr. Galloway. “We believe experiential training will better equip therapists to deliver this medicine in a more meaningful and effective manner.”

It is expected the trial will be completed at the end of October 2022, with the results being published shortly thereafter.

 

ABOUT ATMA JOURNEY CENTERS INC.

ATMA is pioneering a therapist-centered and therapist-driven business model for the psychedelic industry, by building the largest online community platform for psychedelic practitioners.  Education, training, clinical trials, and business support services are all being developed to assist mental healthcare professionals in adopting psychedelic-assisted therapy.  Our philosophy of inclusivity will encourage increased participation from healthcare professionals, which will in turn yield more data and experiences. Overall, this will lead to increased effectiveness and accessibility of psychedelic-assisted therapy. Beginning with a clear focus on psilocybin-assisted therapy, we will be able to expand to other psychedelics as the regulatory environment also expands.  ATMA provides a clear, guided path for healthcare professionals and clinics to build psychedelic-assisted therapies into their current practices.

 

SOURCE ATMA Journey Centers Inc

For further information: MEDIA CONTACT: David Harder, Co-CEO, ATMA Journey Centers Inc., david@atmajourney.com

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