Ananda Pharma Plc (AQSE:ANA, OTCQB:ANANF), the UK biopharmaceutical company, has received acknowledgement from Australia’s Therapeutic Goods Administration for its first clinical trial of a cannabidiol (CBD) drug, allowing the study to proceed under the country’s Clinical Trial Notification scheme.
The study will assess MRX1, a high-purity CBD formulation developed to treat chronic inflammatory pain.
It will be carried out in healthy adult volunteers and is designed to measure how the drug is absorbed, distributed, and cleared by the body (known as its pharmacokinetic profile) as well as to test its safety and tolerability at different doses.
Ananda said the phase I evaluation would generate key early-stage data to support later regulatory filings and to refine dosing levels for future trials in patients.
Ananda's CEO, Melissa Sturgess, said: "We are pleased to receive acknowledgement of our clinical trial under the TGA's CTN scheme, which is an important milestone in advancing our MRX1 development program. The data from this trial will be key for regulatory filings in the US, UK and Europe."
"Australia is an attractive location for clinical research due to its streamlined regulatory process and high-quality clinical trial infrastructure. This strategy is now paying off and we look forward to initiating the study and advancing our efforts to bring MRX1 to patients in need."
The company is developing a range of cannabinoid-based medicines aimed at treating complex, long-term medical conditions.