Ananda Pharma Plc (AQSE:ANA) has secured ethics approval in Australia to begin its first human trial of MRX1, the company’s lead cannabidiol (CBD) drug candidate aimed at treating chronic inflammatory pain.
The green light came from the Human Research Ethics Committee at Alfred Hospital in Melbourne, clearing the way for a phase I study to begin recruiting healthy volunteers.
First doses are expected in the third quarter of 2025, with early results due in early 2026.
The trial aims to understand how MRX1 behaves in the body: How it's absorbed, distributed, and cleared across different doses.
It will also assess safety and tolerability. The asset is being developed to treat conditions like endometriosis and nerve pain from chemotherapy. Phase I will support future regulatory filings in the UK, US, and Europe.
The company hopes the results will also help fine-tune dosing for future clinical trials.
CEO Melissa Sturgess said: "I am incredibly proud of this achievement by our team. 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."