2nd Apr 2025 17:33
(Alliance News) - Ananda Pharma PLC announced on Wednesday that it had received approval for the phase 1 pharmacokinetic study of its lead investigational cannabidiol drug candidate, MRX1, in Australia.
The London-based biopharmaceutical company develops regulatory-approved cannabinoid medicines to treat complex, chronic conditions.
Ananda said the approval from Australia's Alfred Hospital Human Research Ethics Committee, or HREC, confirms "the phase 1 trial protocol meets the necessary ethical standards required to commence recruitment."
The company said data from the study will support regulatory filings in key markets, including the United States, United Kingdom and Europe, and help dosing optimisation for Ananda's future clinical trials.
Ananda's Chief Executive Officer Melissa Sturgess said: "Every step in the drug development process is important, and receiving the green light to proceed with our Phase 1 trial in Australia is a significant milestone in the development of MRX1 towards a regulatory filing."
Ananda said the study's objective is to characterise the pharmacokinetic profile of MRX1 at multiple doses and assess the safety and tolerability of MRX1 in healthy volunteers.
The first patient dose is expected in the third quarter of 2025, and the initial results will be in the first quarter of 2026.
Shares in Ananda Pharma were up 5.9% at 0.45 pence in the Aquis Stock Exchange on Wednesday.
By Lucy Dunnet, Alliance News reporter
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