Improving the lives of those suffering from Rare Disease
Join us in reducing suffering by utilising 5HTx agonists
Health problem
Pain is the most common reason people seek healthcare and a leading cause of disability in the world
of US adults have chronic pain each year (CDC)
of people worldwide are affected by chronic pain (Lancet, 2021)
Pain Management market
Treating chronic pain with opioids has created a crisis of its own. It’s time for a new approach
- Opioids are highly addictive, with enormous abuse risk
- In the US since 1999, approximately 650,000 people have died from opioid overdoses, with 68,630 deaths in 2020 alone.
Number of pills manufactured by the 10 biggest opioid companies (2006-2012)*
Our approach
We are initially tackling a severe, rare pain condition with psilocybin. Broader chronic pain indications can be developed subsequently or in parallel with psilocybin/our proprietary 5HTx agonists.
Problem
A severe rare disease with no licensed medicine
- A disabling orphan condition
- Patients suffering from chronic pain, limb dysfunction and psychological distress
- Approximately 1/3 of those afflicted are unable to return to work
- No licensed medicine, very limited treatment options
Solution
Psilocybin may address this unmet medical need
- Clinical and preclinical data signal efficacy in pain and beyond
- Case studies in the rare disease and associated conditions indicate effect at low doses
- Safe use of psilocybin/5 HTx agonists established in other indications
- Phase IIa Clinical Trial in preparation
Science
Scientific rationale for psilocybin in pain
Modulation of pain
Psychedelics like psilocybin may reduce pain by affecting brain regions involved in perception, emotion, and pain processing
Neuroplasticity
Psilocybin may promote neuroplasticity and reset the brain’s default mode network, enhancing its therapeutic potential for pain
Psychological distress reduction and effects in depression and PTSD
Psilocybin-assisted therapy may alleviate anxiety, depression, and PTSD linked to chronic pain
Anti-inflammatory effects
Psilocybin and other 5-HT2A agonists may reduce inflammation by inhibiting pro-inflammatory cytokines like TNF-α
Accomplishments
On the path to serve patients
- Regulatory and clinical
- Active discussions with with EMA and FDA
- Preparation ongoing for Phase IIa trial in orphan condition
- Manufacturing and supply chain
- Licensed facility for natural psilocybin production audited to EU GACP standard
- Exclusive supply contract with only licensed GMP psilocybin manufacturer in Australia
- Exports to United States and Canada
- Import Permits for Australia and EU countries
Our manufacturing process is highly efficient; leading to low COGS and increased patient accessibiIity
- Modular capacity means we can supply our first indication and take new opportunities as other markets open. Our approach has been validated by multiple exports to the US, bulk permits into Australia and a confirmation from the UN of our freedom to supply partners in the EU/UK
NCEs & Supply Chain
Innovation & Supply Chain
natural biochemical combinations possible
clinical trial to be initiated in target indication
NCEs to date, with provisional patent applications submitted
kg p/a licensed natural product production facility
NCEs purified for initial preclinical testing
active natural product doses p/a cultivaton capacity
Cy Biopharma
Novel Molecules
- Provisional Patents filed on Novel Molecule Library: ergoline derivatives in-silico designed and patient focused
- Inspired by early pain research with LSD and preparing to follow 5HTx trial in opioid refractory pain with Harvard
- Created in collaboration with one of the leading medicinal chemists in the field
- Posited improvements
- Favorable receptor profile
- Sustained relief from pain
- No respiratory depression
- Low abuse potential
- Dosing without supervision
Team
Senior executives with proven track records
- Get in Touch on LinkedIn