The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and the Wales Research Ethics Committee 2 (REC 2) have granted approvals to Oxford Cannabinoid Technologies’ (OCTP) combined Phase I trial application for OCT461201.
OCTP’s lead drug candidate OCT461201 is a selective cannabinoid receptor type 2 agonist which has the potential to treat chemotherapy-induced peripheral neuropathy (CIPN) and irritable bowel syndrome (IBS).
Being carried out in the UK, the first-in-human trial involves healthy subjects and a single ascending dose protocol.
Simbec-Orion Group unit Simbec Research will conduct the trial that aims to show the safety, tolerability and pharmacokinetics of OCT461201 in the trial participants.
OCTP will provide funding for the trial, which will start enrolling subjects soon.
The trial is anticipated to be concluded in the third quarter of this year.
Oxford Cannabinoid Technologies CEO Clarissa Sowemimo-Coker said: “Getting OCT461201 into the clinic so soon after our listing is a huge achievement and is a fitting testament to the hard work and dedication of both OCTP’s talented team and our external partners, Aptuit (Verona) SRL, a subsidiary of Evotec, and Simbec-Orion.
“We are moving ever closer to achieving our core aim of improving the lives of patients living with debilitating pain, whilst also, ultimately, delivering value for shareholders.
“This is an important step for the company and part of our broader strategy which currently incorporates four drug development programmes. We believe that our portfolio approach and extensive library of derivatives continue to provide numerous routes to commercialisation.”