Drug delivery specialist IntelGenx has penned two deals to develop film-based, prescription psychedelics amid a surge of interest—and investment—from the biopharma industry.
Tapping its VersaFilm delivery platform, IntelGenx has teamed with Cybin Corp, a Canadian life sciences company focused on mushroom-based drugs and nutraceuticals, to explore developing an orally dissolving psilocybin strip for depression. A separate feasibility pact with the biotech company ATAI centers on film formulations of an undisclosed psychedelic.
VersaFilm-based products resemble a Listerine breath strip, and they've been approved to treat migraine, schizophrenia and more, the company said. Though the foray into prescription psychedelics is new, it comes with familiar drug delivery goals.
Pairing psilocybin—the psychoactive ingredient found in a variety of mushroom species—with a transmucosal delivery method like an oral strip helps deliver it directly to the bloodstream, bypassing the liver, IntelGenx CEO Horst G. Zerbe, Ph.D., said in an interview.
"When you ingest a conventional tablet, it disintegrates in the stomach and enters the bloodstream," Zerbe said. "It first goes through the liver, a so-called 'first-liver pass' where molecules are metabolized and destroyed—sometimes completely."
The Cybin team hopes the platform could help it develop a quick-acting depression treatment, CEO Doug Drysdale said in an interview. "Sublingual delivery of psilocybin has the potential for faster onset of action, so the patient does not have to wait for an hour or so, which is good for patients with severe anxiety or depression," Drysdale said.
Under the feasibility pact, IntelGenx will develop a VersaFilm prototype that Cybin will use to develop four psilocybin doses for testing against a 25-mg psilocybin capsule at the University of the West Indies in Kingston, Jamaica. That trial could kick off before year-end, Drysdale said. Cybin is meanwhile plotting a pivotal, 120-patient study to run next year.
Avoiding that first pass metabolism is critical for a drug like psilocybin, which loses 50% to 60% of its bioavailability when it moves through the liver, Drysdale explained. A film version of the med could help Cybin reduce dosing up to tenfold and potentially cut the risk of side effects such as nausea and panic attacks, he said.
Health Canada recently greenlighted the drug's use in a handful of terminally ill cancer patients, Drysdale noted, but psilocybin remains a schedule 1 drug subject to strict rules that complicate clinical trials. Cybin is planning its phase 2 in Jamaica because the regulatory framework there will be more forgiving, he said.
Meanwhile, under its ATAI deal, IntelGenx has pledged to develop a prototype of a psychedelic drug—as yet undisclosed—that the biotech plans to push into the clinic.
Much like Cybin, ATAI sought out IntelGenx's VersaFilm platform to avoid first pass metabolization of psychedelic drugs, ATAI Chief Scientific Officer Srinivas Rao, M.D., Ph.D., said.
It's part of a broader push by ATAI to pit psychoactive substances against conditions like depression and PTSD. In July, ATAI debuted Viridia, a subsidiary that aims to develop formulations of the active ingredient in the psychoactive drink ayahuasca—N,N-dimethyltryptamine, or DMT—for use alongside talk therapy to treat "a variety of mental health disorders."
Viridia hopes to take advantage of the brain's ability to change itself, known as neuroplasticity, through a psychedelic experience that could help patients tackle ailments such as depression.
It will pair those DMT treatments with a recently unveiled digital therapeutic that uses digital biomarkers to help doctors tailor doses for individual patients.
Meanwhile, another drugmaker with a psilocybin bent recently went public: In early September, Compass Pathways—of which ATAI owns 29%—filed for a Nasdaq IPO to take its psilocybin therapy, COMP360, through mid-stage testing.
That move can only be good for the nascent psychedelics field, Drysdale said, adding that Compass' progress and public presence could inspire more funding for psilocybin work.