Ananda Developments Plc (AQSE:ANA) has signed up a contract research organisation to carry out a pharmacokinetics study for its lead CBD-based asset, MRX1.
Southern Star Research, a leading Australian CRO, will carry out the Phase 1 study to investigate the compound's pharmacokinetic profile, tolerability and safety in healthy volunteers.
"This study represents a significant milestone in MRX1's journey to market, providing us with key data for MRX1's licensed drug development," said Ananda chief executive Melissa Sturgess.
Sturgess highlighted that Southern Star's "deep expertise" in clinical research, particularly in the field of cannabinoids, will complement Ananda's own capabilities and accelerate the development of MRX1.
Data from the trial will provide useful background information when discussing MRX1 and the wider Ananda drug development pipeline with potential investors, in partnering discussions with pharmaceutical companies, the company said, as well as any future regulatory applications.
Ananda noted significant financial advantages of running the study in Australia, including an R&D tax incentive of up to 43.5% of eligible research and development costs.
The study will be conducted via Ananda's wholly-owned Australian subsidiary, Tiamat Australia.
MRX1 is an oil-based, orally administered drug candidate which is to be used in two Phase 2 clinical trials, the first evaluating MRX1's efficacy in treating chemotherapy-induced peripheral neuropathy (CIPN) and another evaluating efficacy and retention in endometriosis patients.
Southern Star managing director Dr David Lloyd highlighted that the CRO has managed and executed Phase I clinical trials and also clinical studies involving cannabinoids such as CBD.
"The therapeutic potential of CBD is still yet to be fully discovered, and we hope that our collaboration with Ananda will further support the advancement of MRX1 and the wider acceptance of CBD as a therapeutic solution within mainstream health," he said.