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Research, Drug Development & ManufacturingCompany-Led Drug Development & Commercialization
Lead program: Phase II

Xpira Pharmaceuticals

1 Drug Candidate

Xpira Pharmaceuticals is a Toronto-based private biotech developing psilocybin-assisted therapy for anorexia nervosa (AN), a condition with no currently approved pharmacological or psychotherapeutic treatments. Founded in 2020 by leaders from the Canadian and Dutch pharmaceutical industries, the company received FDA IND approval in September 2022 for a Phase 2a clinical trial. Xpira is a portfolio company of Origin Therapeutics Holdings. Dr. Allan Kaplan of CAMH and the University of Toronto serves as VP of Clinical Development.

Development Programmes

1

Psilocybin (25mg oral)

Psilocybin
Phase IIinactive
Eating Disorders

Anorexia nervosa

Programme Tracker

Eating Disorders

Primary: US (FDA)
Phase IIinactive

No public updates since 2022 IND clearance; trial (NCT04505189) originally estimated completion June 2024; parent company Origin Therapeutics merged into Safe Supply Streaming Co.

Milestones

ind-filed

Completed

Actual: Sep 1, 2022

FDA IND approval received for psilocybin in anorexia nervosa — randomized, quadruple-masked, parallel-group trial (25mg vs 1mg active placebo, target n=60 across 6 sites in US/Ireland/UK)

Why it matters: One of the first FDA INDs for psilocybin in anorexia nervosa. AN has the highest mortality of any psychiatric disorder with very few effective treatments. The 6-site international design was ambitious for a small biotech.

Company milestone

Completed

Actual: Sep 1, 2023

Parent company Origin Therapeutics merged with Safe Supply Streaming Co. on CSE

Why it matters: Corporate restructuring of the parent company may have diverted resources and attention from the Xpira trial. Safe Supply Streaming operates in a completely different space (safe drug supply).

Company milestone

Completed

Actual: Jun 1, 2024

Original trial completion date passed (June 2024) with no enrollment updates, data readouts, or press releases since 2022

Why it matters: Over 3 years of silence after IND clearance is a strong signal the trial has stalled. No enrollment milestones were ever publicly announced. The programme may be dormant pending corporate strategy decisions or new funding.

Recorded Events

Jun 1, 2024: Company milestone

Sep 1, 2023: Company milestone

Sep 1, 2022: ind-filed

Quick Facts

Type
Private Biotech
Founded
2020
Lead Stage
Phase II
Website
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