Emyria announces agreement for multi-site Phase 3 trial for EMD-RX5

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Emyria (ASX:EMD) has announced it has entered into a Masters Service Agreement (MSA) with the leading Australian Contract Research Organisation, Clinitrials.

Emyria is a clinical-stage biotechnology company leveraging real-world patient data to develop treatments for unmet needs.

Under the MSA, Clinitrials will lead the preparation, ethics submission, patient recruitment and conduct of Emyria’s Phase 3 clinical trial at five or six sites across Australia.

Emyria said the trial is expected to support the registration of EMD-RX5 with the TGA as an over-the-counter treatment for the symptoms of psychological distress.

The MSA also allows the companies to rapidly commence additional clinical trials to support Emyria’s growing drug registration programs comprising ultra-pure cannabinoid-based medicines and novel MDMA analogues.

The Phase 3 trial for EMD-RX5 is expected to commence immediately following the successful completion of the Phase 1 study currently in progress.