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Psilocybin trial receives FDA approval for IND application

Origin Therapeutics’ portfolio company, Xpira Pharmaceuticals, has received the approval.

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Origin Therapeutics’ portfolio company, Xpira Pharmaceuticals, has received FDA approval for its Psilocybin Trial IND Application.

Following the FDA approval, Xpira will commence a Phase 2a clinical trial to study the efficacy of psilocybin-assisted therapy in patients diagnosed with the eating disorder Anorexia Nervosa.

Anorexia Nervosa is a serious mental illness that often results in loss of life, and currently has no approved therapeutic regimen. 

Xpira, focused on psychedelic medicines for the treatment of eating disorders, particularly for patients who have not responded well to conventional therapies, hopes that its latest phase of clinical trials will result in the creation of a successful treatment plan for patients with the eating disorder.

“We have always been impressed with Xpira’s commitment to safety, efficacy, and clinical expertise. They intend to be a global leader in the psychedelic treatment of eating disorders, and today’s announcement is another step in the right direction.

“With FDA approval for its IND application, Xpira has cleared a major hurdle on the path to development – and, ultimately, commercialisation – of a new treatment for Anorexia Nervosa. 

“We have full confidence in the team at Xpira and can’t wait to see what this next phase of clinical trials will bring.”

Origin Therapeutics recently announced that it has also completed an investment in Clairvoyant Therapeutics which will be proceeding with a Phase 2 clinical trial for the clinical validation of psilocybin for the treatment of alcohol use disorder.

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