Emyria has begun dosing participants in a Phase 1 clinical trial assessing the safety and bioavailability of its ultra-pure oral CBD formulation EMD-RX5 compared to Epidyolex.
The company previously said the dose form has the potential to support multiple TGA and FDA registration programs including in Australia as an over-the-counter (Schedule 3) CBD treatment for the symptoms of psychological distress.
In a recent animal study, the formulation demonstrated greater peak concentration and improved bioavailability compared to the equivalent Epidyolex dose over 24 hours.
Once the Phase 1 study is complete, contract research firm Clinitrials will help coordinate a Phase 3 trial at five to six sites across Australia.
Managing director Dr Michael Winlo said: “Our Phase 1 clinical trial, now commenced, will directly compare the safety and bioavailability of EMD-RX5 to Epidyolex.
“Our first ultra-pure cannabidiol formulation versus the only successfully registered and reimbursed CBD oil in the global market.”
Cann Group shares jumped 15% today (Thursday) after commercial cultivation formally started at its Mildura glasshouse.
The company said 4,000 cuttings were transferred from its southern facility with the crop expected to be harvested in June.
Meanwhile, the company has released its first GMP dried flower product from the southern plant in Melbourne.
“Demand for the dried flower form remains high and Cann has increased production of its high-THC cultivars to help meet this demand,” it said. “Cann is well placed to increase the volume of this product form with the aim of gaining greater market share.”
The company also said Satipharm is now being manufactured in Mildura to support its S3 registration process.
The trio of announcements saw shares climb to $0.41c, its highest since July 2021.
Creso Pharma’s acquisition target Sierra Sage Herbs (SSH) has expanded its US distribution network, with 20,000 new points of sale in bricks and mortar stores across the country.
SSH now has more than 110,000 points of sale for its Green Goo products in the US.
Creso CEO and managing director William Lay said: “Once the acquisition completes, we will have the ability to leverage these points of sale to drive sales of our own established product suite, while benefiting from the ongoing sale of SSH products.”
Creso’s purchase of SSH is expected to complete in May 2022.
Cronos Australia chairman and director Shane Tanner has resigned after three-and-a-half years to pursue private investments.
Tanner joined the board in October 2018 as its inaugural chairman and steered the company through its initial public offering and subsequent ASX listing in November 2019. He also played a key role in negotiating the acquisition of CDA Health late last year.
Dr Marcia Walker will act as interim chair while a permanent replacement is sought.
MGC Pharma chief financial officer Daniel Kendall has stepped down, with the firm’s managing director and CEO Roby Zomer assuming the role on an interim basis.
Due to the growth of its European Union and Israeli manufacturing and research operations, the company has decided to appoint a London-based CFO going forward. Zomer will also relocate there shortly.
The ASX-listed firm has been dual listed on the London Stock Exchange since early 2021.