Cybin Moves Forward With Clinical Trial On Psilocybin Oral Film

Cybin Inc. CYBN CLXPF, a biotechnology company focused on progressing psychedelic therapeutics, announced on Tuesday it has received initial clearance to begin a Phase IIa clinical trial on psilocybin for patients suffering from major depressive disorders (MDD).

The head-to-head study will test Cybin’s proprietary sublingual psilocybin formulation against a 25mg psilocybin capsule on 40 patients.

The trial has been approved by a review board at the University of the West Indies in Jamaica, where the research will be undertaken. The company still awaits final confirmation by Jamaica’s Ministry of Health to begin testing the product on human subjects.

Cybin’s psilocybin oral dissolving film product, developed via a partnership with IntelGenx Corp. IGX IGXT, is expected to deliver faster absorption of psilocybin into the bloodstream. The trial aims to prove the benefits of this method, which is also expected to deliver a shorter duration of action and a lower effective dose.

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“We are planning several additional studies to expand our clinical understanding of this potentially ground-breaking therapeutic,” Cybin CEO Doug Drysdale said.

The company is currently working on a pipeline of four potential psychedelic drug candidates.

If this trial turns out successful, Cybin expects to continue with a Phase IIb trial on 120 patients, wherein the safety and efficacy of the oral dissolving film will be assessed.

The company has stated that the Jamaican trial will adhere to the International Conference on Harmonization-Good Clinical Practice guidelines, which could facilitate the translation of its clinical data into other jurisdictions such as the U.S., Canada and Europe.

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