So mushroom for growth: Bioxyne subsidiary inks psilocybin deal with Swiss pharma company

Subsidiary of Bioxyne enters deal with Cy Biopharma AG of Switzerland
Companies will develop psilocybin products to treat depression and pain in Australia and New Zealand markets
Deal enables manufacture and supply of Australian, New Zealand, US, and European clinical trials market with novel Psilocybin products

Special Report: Bioxyne says BLS Wholesalers has inked a commercial supply and collaboration agreement with Cy Biopharma AG of Switzerland to develop psilocybin products targeting treatment of depression and pain in Australia and New Zealand.

Bioxyne (ASX:BXN) says the deal with biopharmaceutical company Cy Biopharma AG will also provide BLS with the opportunity to manufacture and supply the Australian, New Zealand, US, and European clinical trials market with novel Psilocybin products.

BLS will also be able develop proprietary formulations and drug delivery methods, and supply Australian patients via the authorised prescriber scheme.

BLS Wholesalers is a wholly owned Breathe Life Sciences (BLS) subsidiary, which in turn is a wholly-owned subsidiary of BXN. It is the company’s licencing entity operating in Australia.

BXN says Cy Biopharma will exclusively supply BLS with Psilocybe cubensis fungi for Australia and New Zealand.

BLS Wholesalers Pty Ltd is the only licensed Australian manufacturer of MDMA and psilocybin.

BXN announced in April the company had been granted an upgraded and amended wholesale licence for MDMA and Psilocybin (schedule 8) finished products by the Therapeutic Goods Administration (TGA).

Cy Biopharma focused on psychedelic development

Founded in 2020 and based in Switzerland since 2021, Cy Biopharma AG is a privately held, international biopharma company targeting treatments for rare conditions.

Led by CEO Dr Anton Hoos, the company is focused on development of psychedelics, which are 5-HT2A receptor agonists which can lead to profound changes in perception, cognition, and mood.

Cy Biopharma is planning clinical development for psilocybin and engineering next generation 5HTx agonism-based novel psychedelic molecules with the goal of delivering improved pharmacological profiles suited to its target indications.

In the US, Cy Biopharma Inc has been supporting an FDA-approved pilot trial in oncological pain via a philanthropic partnership.

Initiated by principal investigator Dr Beaussant at the Harvard Dana-Farber Cancer Centre, the study seeks to examine the potential of psilocybin to treat opioid-resistant pain.

In South America, Cy Biopharma is engaged in process research and manufacture to ensure professional cultivation of naturally derived serotonin receptor agonists. The company has been granted multiple import permits for psychedelics into the US and Europe.

Treating an unmet clinical need

In July 2023 the TGA rescheduled Psilocybin and MDMA from Schedule 9 to Schedule 8 for the psychotherapy assisted treatment of PTSD and treatment resistant depression.

While MDMA and psilocybin are not registered, the Authorised Prescriber Scheme will allow access to use by experienced psychiatrists under prescription.

Hoos says there is a huge unmet medical need that 5HTx agonists may serve.

“Following the Australian government’s pioneering decision to allow select experts to prescribe psilocybin, Cy Biopharma is pleased to enter into this partnership with BLS.,” he says.

“Together we plan to build a reliable supply of pharmaceutical grade, naturally derived psilocybin for patients in Australia and New Zealand.”

First Aussie-made GMP Psilocybin capsules

In the coming 90 days BLS is planning to manufacture the first Australian-made GMP Psilocybin capsules in Australia for commercial supply to approved clinical trials and patients, via the Authorised Prescriber Channel.

During the time frame BLS also expects to supply its first psilocybin products to research organisations in Australia and New Zealand.

BXN CEO Sam Watson says psychedelics are showing significant potential in the treatment of various mental health conditions and have become a “beacon of hope for the large cohort of patients who do not respond to conventional treatment options”.

“In Australia, 10.4% of people report experiencing symptoms of depression, and 33% of patients diagnosed with depression respond inadequately to current treatments within certain indications,” he says,

“Our goal is to help these patients get their lives back.”

BXN says it is not able to determine the financial contribution from the collaboration at this stage but is committed to improving patient access and affordability.

This article was developed in collaboration with Bioxyne, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.