“Now, with EMD-RX7, we have a convenient dose form that we believe can deliver higher CBD exposures more efficiently allowing us to target a range of prescription-only indications – in other words, help the broad range of major unmet needs that affect the patients we treat every day at our clinical service subsidiary, Emerald Clinics,” says MD.
Emyria Ltd (ASX:EMD) has released a second ultra-pure CBD dose form dubbed EMD-RX7 just as its first treatment – EMD-RX5 – enters phase 1 clinical trials.
EMD-RX7 has demonstrated more than four times the bioavailability (percentage of dose reaching the bloodstream) compared to the only registered CBD treatment in a recent pharmacokinetic animal study, indicating lower doses may be required for clinical results.
Higher dose CBD treatments of more than 300 milligrams have shown clinical efficacy in several indications: epilepsy, rheumatoid arthritis, social anxiety disorder, insomnia and graft versus host disease.
Addressing unmet prescription CBD needs
“Following the commencement of our Phase 1 clinical trial for EMD-RX5, we are delighted to announce the expansion of our proprietary, ultra-pure, CBD treatment portfolio with the addition of EMD-RX7,” Emyria managing director Dr Michael Winlo said.
“Emyria’s Real World Data suggests there are a range of clinical indications that respond to high daily CBD doses.
“However, as all CBD treatments in Australia are currently unregistered (with the exception of Epidyolex), patients must pay significant out-of-pocket costs to receive cannabinoid treatments.
“We also know that most CBD available to patients has poor bioavailability, meaning only a small amount of active medicine enters the bloodstream where it can be effective.
“This is why we have developed a range of convenient, ultra-pure CBD capsules with improved bioavailability. EMD-RX5 is an ideal dose form to support our low-dose registration strategy.
“Now, with EMD-RX7, we have a convenient dose form that we believe can deliver higher CBD exposures more efficiently allowing us to target a range of prescription-only indications – in other words, help the broad range of major unmet needs that affect the patients we treat every day at our clinical service subsidiary, Emerald Clinics.
“We are now planning our Phase 1 trial for EMD-RX7 and will continue to develop unique, proprietary, ultra-pure, cannabinoid-based medical treatments for other indications.”
Emyria is now advancing two proprietary, ultra-pure CBD treatments towards registration with the Therapeutic Goods Administration (TGA) in Australia and the Food and Drug Administration (FDA) in the USA:
- EMD-RX5 targeting a 1 to 3 capsules per day, ‘over-the-counter’ scheduling for a range of low-dose, CBD-only indications including psychological distress; and
- EMD-RX7 targeting a 1 to 3 capsules per day prescription-only scheduling for a range of indications requiring higher CBD dosing.
The company has begun phase 1 clinical trials for EMD-RX5 and expects EMD-RX7 phase 1 trials to begin in the second half of this year.
Emyria is continuing to investigate proprietary cannabinoid formulation development with plans to further expand its library of cannabinoid-based medical treatments and novel MDMA-analogues.
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