Cybin (NYSE:CYBN), a biotech company focused on progressing psychedelic therapeutics, has announced that the FDA has given them authorization for Phase 2 clinical trials evaluating psychedelic-assisted psychotherapy with psilocybin for frontline clinicians experiencing COVID-related distress.

Cybin recently announced that they will be training therapists who will participate in the clinical study using the EMBARK program, a psychotherapy model that aims to deliver supportive healing in conjunction with psychedelic therapeutics. The program is designed as a transdiagnostic psychotherapy model that can be adapted to address a broad range of clinical indications and populations, including depression, alcohol use disorder and anxiety.

EMBARK’s six clinical domains — Existential-Spiritual, Mindfulness, Body Aware, Affective-Cognitive, Relational, Keeping Momentum — represent the broad spectrum of ways in which therapeutic benefits may arise in psychedelic treatment and the equally broad training needed to prepare therapists to support them all.

“When we first created EMBARK, we canvassed twenty different psychedelic-assisted psychotherapies. We found that some therapies left out important aspects, like people’s spiritual experiences, somatic experiences, or human relationships,” said Dr. Alex Belser, EMBARK’s co-author and Cybin’s chief clinical officer. “Patients were telling us that these experiences were central to their healing, but many therapies seemed to be missing critical pieces.”

To address the challenge, Cybin developed EMBARK, which provides an open architecture to support the varieties of psychedelic experiences within a therapeutic framework.

The use of psychedelic therapies for PTSD has become increasingly common for people in occupations that experience other people’s trauma up close and personal, such as firefighters, police, healthcare workers and military personnel.  

The trial’s primary investigator, palliative care specialist Dr. Anthony Back, received an investigational new drug (IND) approval letter from the FDA, which gives the company authority to proceed with the Phase 2 trial.

The FDA states that INDs may be employed for “experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place.”

Cybin’s advance to current Phase 2 trials with psilocybin for pandemic healthcare workers was hastened by a 2018 decision by the FDA, which designated psilocybin therapy for treatment-resistant depression as a “breakthrough therapy,” meant to expedite the development and review of new drugs for serious or life-threatening conditions.

“Throughout the Covid-19 pandemic, nurses, doctors, and healthcare professionals on the frontlines have worked hard to provide care under extremely difficult circumstances,” Dr. Belser said. “Understandably, under this stress, many frontline healthcare workers have experienced symptoms of depression and burnout.”

The Phase 2 clinical trial, set to be conducted at the University of Washington, will enroll 30 frontline clinicians, including physicians, nurse practitioners, physician assistants and nurses, who suffer from clinically significant symptoms of depression and anxiety following work exposure during the Covid pandemic.

“Psychedelic medicines and the great healing potential they hold have only just begun to find their place in our culture and its array of therapeutic approaches. EMBARK represents an important step forward in that process,” said EMBARK co-creator Bill Brennan.

Cybin believes the trial with Covid-distressed healthcare workers will generate clinical evidence validating EMBARK and allow for learnings to be applied to future clinical studies with their psilocybin formulation CYB003.