Clinical Programme 1
OCT461201 is a new chemical entity, CB2 receptor agonist, chemically synthesized to behave like a cannabinoid. It is currently in Phase I clinical trials, being completed by Simbec Orion and completed its Single Ascending Dose Phase I Clinical Trial in healthy volunteers in October 2023. As we begin planning for Phase II Trials, we will also complete our planned Multiple Ascending Dose study, also in healthy volunteers.
Our initial target indication for OCT461201 is a first-in-class treatment for chemotherapy-induced peripheral neuralgia (CIPN). On average, an estimated 60% of people undergoing chemotherapy are affected by CIPN after 3 months[1]. The hallmarks of CIPN are pain, numbness and tingling in the extremities. CIPN can be progressive, enduring, often irreversible, leading to many years of debilitation and suffering[2].
OCT461201 is also being evaluated for treating pain associated with Irritable Bowel Syndrome (IBS). Cases of IBS in the US in 2020 reached 17,000,000. In the UK this figure was nearly 6 million.[3]
A pre-clinical study of OCT461201 showed a successful reduction in CIPN induced pain. Other studies have shown the potential for cannabis in treating IBS-type pain. These studies have been done with cannabis extracts. Our drug candidate for IBS and CIPN exploits the same receptor targeted by some natural cannabis extracts, but it is chemically modified to ensure that it effectively and exclusively binds to the key receptor (CB2) in the nerves and immune cells that contribute to controlling the pain response, and it will do this in the same way every time a patient takes it.
[1] Yang et al. J Exp Clin Cancer Res (2021) 40:331 https://doi.org/10.1186/s13046-021-02141-z
[2] Bandos H et al., J Natl Cancer Inst. 2018 Feb 1;110(2):djx162. doi: 10.1093/jnci/djx162
