UK-based biopharmaceutical company Ananda Pharma plc (AQSE: ANA) announced on Wednesday that it has received approval from the Alfred Hospital Human Research Ethics Committee (HREC) in Australia for its Phase 1 pharmacokinetic study of MRX1, its lead cannabidiol (CBD) drug candidate. This approval allows the company to proceed with recruitment for the study, expected to commence with the first patient dose in Q3 2025, and initial results anticipated by Q1 2026.

The study will assess the pharmacokinetic profile, safety and tolerability of MRX1 at multiple doses in 20 healthy adult volunteers, including 10 males and 10 females. The trial aims to gather critical data to support regulatory filings in key markets, such as the US, UK and Europe, as well as inform future clinical trial designs for MRX1's use in treating complex chronic inflammatory pain conditions.

Although this Phase 1 study is not required for the start of Ananda's Phase 2 trials for endometriosis and chemotherapy-induced peripheral neuropathy in collaboration with the University of Edinburgh, its findings will contribute to future regulatory filings and the design of subsequent trials. The study is sponsored by Ananda's wholly owned subsidiary, Tiamat Australia Pty Ltd.

Ananda Pharma is developing cannabinoid-based medicines for complex chronic conditions and works closely with prominent academic institutions such as the University of Edinburgh and Great Ormond Street Hospital.