Benzinga | Nov 30, 2021 04:44PM EST

Cybin Announces FDA Investigational New Drug And Institutional Review Board Approvals For A Co-Funded Phase 2 Clinical Trial To Treat Frontline Clinicians Experiencing COVID-Related Distress

Cybin Inc. (NEO:CYBN) (NYSE:CYBN) ("Cybin" or the "Company"), a biopharmaceutical company focused on progressing "Psychedelics to Therapeutics(tm)", today announced that the U.S. Food and Drug Administration ("FDA") has authorized an investigator-initiated randomized, placebo-controlled Phase 2 clinical trial evaluating psychedelic-assisted psychotherapy with psilocybin for frontline clinicians experiencing COVID-related distress. The trial will be conducted at the University of Washington and will aim to treat symptoms of depression, anxiety, burnout and post-traumatic stress among frontline doctors, nurses and healthcare professionals. The trial's Primary Investigator, Dr. Anthony Back, received an investigational new drug ("IND") approval letter from the FDA, which provides authority to proceed with the Phase 2 trial.

Further to the authorization from the FDA, the study has also received Institutional Review Board ("IRB") approval at the University of Washington. This investigator-initiated trial will be hosted in Seattle, a city significantly impacted by the COVID-19 pandemic and will be funded by multiple organizations.

"This study offers an important opportunity to assess psychedelics-assisted therapy as a new modality for clinicians who have suffered as a result of their frontline work in the pandemic," said Dr. Anthony Back.

To support the initiative, Cybin's Chief Clinical Officer, Alex Belser, PhD and Bill Brennan, PhD (candidate) developed EMBARK, a six-domain model of psychedelic-assisted psychotherapy. EMBARK was designed as a transdiagnostic psychotherapy model that can be adapted to address a range of clinical indications and populations. In collaboration with Dr. Anthony Back and Ladybird Morgan, RN, MSW, an adapted version of EMBARK has been co-authored to treat COVID-related burnout and symptoms of depression among frontline healthcare workers, and this version includes material that specifically addresses cultural inclusion anticipating a diverse population of clinicians. Cybin launched the EMBARK Psychedelic Facilitator Training Program for study facilitators in October 2021.

"Throughout the COVID-19 pandemic, nurses, doctors, and healthcare professionals on the frontlines have worked hard to provide care under extremely difficult circumstances. Understandably, under this stress, many frontline healthcare workers have experienced symptoms of depression and burnout. We believe psychedelic medicine, when given with a supportive psychotherapy program like the EMBARK approach, may provide a promising treatment approach to bolster mental health," said Dr. Alex Belser, Cybin's Chief Clinical Officer.

"This clinical trial provides an opportunity to better understand the effectiveness of combining psilocybin and EMBARK. Learnings from this combination Phase 2 trial will inform the use of EMBARK in Cybin's upcoming human studies using CYB003, a proprietary deuterated psilocybin analog that has the potential to reduce clinic times and dosing levels in half as well as potentially reduce side effects and adverse events," said Doug Drysdale, Chief Executive Officer of Cybin.