A new approach to tackling chronic pain

30% of people worldwide suffer from chronic pain; many take opioids. Join us in finding a better way to reduce suffering by utilising 5HTx agonists. 

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Pain is a leading cause of disability in the world and the most common reason people seek healthcare. At Cy Biopharma we strive to find new approaches to help patients in need

For over 30 years in the pharmaceutical industry & biotech, I have contributed to selecting, developing, and getting many therapies to market.  I know first-hand the impact possible when dedicated people advance the science and build a great business backed by sophisticated investors.

In my view, Cy Biopharma has the potential to make just such an impact – by changing the lives of patients suffering from chronic pain and by capitalizing on a huge business opportunity.

We are a professional team with solid pharma experience targeting a rare pain condition with psilocybin; this plan will allow a rapid, lower risk development, and enable us to serve patients quickly. It should also result in an attractive return on investment.

The first orphan indication is designed to be the foundation from which we begin to seize the myriad opportunities to alleviate unmet medical need in much larger patient groups using newly designed molecules. We hope you will join us on the path to better serve patients.

Tony Hoos M.D., PhD, MBA
CEO Cy Biopharma

Health problem

Pain is the most common reason people seek healthcare and a leading cause of disability in the world

Chronic Pain,The Lancet,Vol.397, No.10289 May 27, 2021

of US adults have chronic pain each year (CDC)

0 %

of people worldwide are affected by chronic pain (Lancet, 2021)

0 %

Pain Management market

$90-120bn
2027 75%
$80bn
2021 100%
CAGR: 4-7%
Est. Allied Market Research/ Mordor Intelligence

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.
Chronic Pain,The Lancet,Vol.397, No.10289 May 27, 2021

Number of pills manufactured by the 10 biggest opioid companies (2006-2012)*

*Washington Post, 76 Billion Opioid Pills; Newly released Federal Data unmasks the epidemic', July 16, 2019 (accessed Oct 22)

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

90000 +

clinical trial to be initiated in target indication

NCEs to date, with provisional patent applications submitted

25

kg p/a licensed natural product production facility

18000

NCEs purified for initial preclinical testing

active natural product doses p/a cultivaton capacity

M
Binding pocket for LSD. Left hand-side main view of the pocket, Centre hydrophobicity and right hand-side depth of the pocket. This pocket accommodates the ligands and measure approx. 716 Å
Alignments binding pocket RMSD 1.06. Red surface 5hT-2A and yellow for 5HT-2B, Both LSD structures wew use display the positioning of the R-groups after the amide.

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

Tony Hoos M.D., PhD, MBA
CEO
Former SVP at GSK where he headed Medical for Europe as well as the Rare Diseases Business Unit. Executive team at Merck Serono and Head of Medical for Amgen Europe. Founder of global non-profit Patient Focused Medicines Development.
Steffen Stürzebecher M.D., PhD
CMO (designated)
Serial CMO and SVP in clinical R&D with 40 years of pharmaceutical experience spanning pre-clinical and clinical research, translational medicine, medical affairs and marketing. Steffen is a board certified pharmacologist and leads Cy’s pre-clinical, clinical and regulatory R&D activities.
  • Get in Touch on LinkedIn
James Morrison LLB BCL
CBO
Law, commodities and pharmaceuticals trading. Working with national regulators to progress Cy strategy and maintain key partnerships. Researched and taught at University of Oxford and studied at the Sheffield Institute of Biotechnology Law and Ethics.

Join us on our mission to deliver

A new approach to tackling chronic pain

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Modulation of pain

Scientific evidence suggests that pain is a perceptual experience inferred from bodily state (i.e., embodied) and socio-environmental context (i.e., embedded in the environment in which pain is experienced). As such, an individual’s experience of pain is influenced by a wide variety of sensory, affective, cognitive, social, and bodily cues interpreted within current and evolutionary contexts. The mechanisms by which psychedelics, including psilocybin, may provide analgesia are not entirely clear. However, it has been suggested that acute psychedelic experiences that occur following the intake of psychedelics may influence activity in brain regions that are not only involved in processes that regulate emotion, cognition, memory, and self-awareness, but that are also associated with processes leading to perceptual experience of ‘embodied’ and ‘embedded’ pain (Whelan and Johnson, 2018).

Psilocin binds to several 5-HT receptors. The 5-HT2A and 5-HT2C receptors in the central nervous system are involved in peripheral and centrally mediated pain processes as well as the regulation of mood, anxiety, and cognition (Patel and Dickenson, 2018; Whelan and Johnson, 2018). The 5-HT2A and 5-HT7 receptors are involved in anti-nociceptive actions of the rostral ventromedial medulla of the descending pain inhibitory pathways that inhibit onward transmission of nociceptive information in the spinal cord (Whelan and Johnson, 2018).

The decrease in total number of cell surface 5-HT2A receptor binding sites in the brain, and
potentially the promotion of internalisation of these receptors, caused by psychedelics such as
psilocybin may also contribute to decreased signalling in pathways responsible for nociception
(Zia et al., 2023).

Neuroplasticity

Research suggests that psychedelics promote neuroplasticity and that serotonergic psychedelics, including psilocybin, increase neuritogenesis, spinogenesis, and synaptogenesis (Ly et al 2018). The concept of a reset effect on the brain’s default mode network involved in the chronification of pain by psilocybin (Whelan and Johnson, 2018; De Ridder et al, 2022) may add to the therapeutic potential.

Psychological distress reduction and effects in depression and PTSD

Pain often leads to psychological distress, including anxiety and depression, due to the persistent and
debilitating pain experienced by patients (Taylor et al 2021). Psilocybin-assisted therapy has shown potential in alleviating mood and behavioural disorders including depression and post-traumatic stress disorder (Whelan and Johnson, 2018; Perez et al 2023).

Anti-inflammatory effects

There is emerging evidence in animal models that 5-HT2A agonists have powerful anti-inflammatory effects by reducing inflammatory cascades mediated by pro-inflammatory cytokines such as tumour necrosis factor-alpha (TNF-α). This was demonstrated by the findings that activation of 5-HT2A receptors with psychedelics, including psilocybin, produces a potent anti-inflammatory effect (Flanagan and Nichols 2018; Mason et al 2023).