- Emyria has received an ethics approval to start Phase 3 clinical trial
- Prescient signs manufacturing deal with Q-Gen to produce OmniCAR cell lines
Emyria (ASX:EMD) has received an ethics approval for its pivotal EMD-RX5 Phase 3 trial, with patient recruitment now set to commence.
The Phase 3 clinical trial will study Emyria’s first Ultra-Pure CBD candidate, EMD-RX5.
Successful completion of the trial will support the registration of EMD-RX5 with the TGA as a Schedule 3, over-the-counter treatment for the symptoms of psychological distress.
The study’s primary endpoints are changes in validated psychological distress symptom scores, while secondary endpoints include validated measures of sleep, pain and other quality of life scores.
Clinical sites will be opened and managed across Australia by Clinitrials.
“We believe a successfully registered OTC medicine in this category represents a large opportunity for Emyria to address a major unmet health need,” said Emyria CEO, Dr Michael Winlo.
Emyria is on a high following the recent investment from Andrew Forrest’ Tattarang fund. Tattarang’s new VC fund Tenmile has invested $5m into Emyria for a 7% stake.
The company has uniquely created and screened over 125 MDMA-inspired analogues, led by Professor Matt Piggott and in partnership with the University of Western Australia.
Better known as ecstasy, these MDMA analogues could potentially be used as next generation psychedelic-assisted therapies for neurological disorders like Parkinson’s disease.
Emyria share price today:
Prescient signs deal with Q-Gen
Clinical stage oncology biotech, Prescient Therapeutics (ASX: PTX), has entered into a manufacturing services agreement with specialist cell therapy manufacturer, Q-Gen Cell Therapeutics.
The agreement will see Q-Gen produce its OmniCAR cell lines for PTX’s upcoming clinical trials, with initial work now already commenced.
Manufacturing will take place at Q-Gen’s dedicated Brisbane facility, which produces autologous and allogeneic cell therapies for local and international pharmaceutical companies and academic research groups.
Q-Gen is the cell therapy manufacturing arm of the QIMR Berghofer Medical Research Institute, and is one of Australia’s leading producers of cell-based medicines.
Prescient has commenced the technology transfer process to Q-Gen for the OmniCAR-T cell manufacturing.
Prescient share price today:
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