Emyria Ltd (ASX:EMD) has received positive Phase 1 trial data for its proprietary capsule EMD-RX5, which indicates “ideal bioavailability, safety and tolerability” among 12 healthy and demographically diverse volunteer subjects.
The ultra-pure CBD capsule, EMD-RX5, demonstrated excellent bioavailability and dose delivery profile for targeted indications during the Phase 1 pharmacokinetic (PK) crossover study with Epidyolex®, the only TGA and FDA registered CBD medicine.
Compares well against existing treatment
The company said the trial demonstrated that EMD-RX5 compared well against Epidyolex, showing:
- Excellent safety and tolerability with no gastrointestinal upset or adverse events of concern at test dose of 150 milligrams;
- Equivalent bioavailability and less variability;
- Higher CBD exposures three to eight hours after dosing, indicating EMD-RX5 provides more predictable drug exposure over time, is suited for non-acute indications and supports a preferred once to twice daily dosing regime; and
- Twice the bioavailability compared to other, plant-derived CBD products with published pharmacokinetics data.
Leveraging prior data to support US registration
EMD-RX5 was bioequivalent to Epidyolex® in total drug exposure (bioavailability) providing potential for Emyria to leverage prior data on Epidyolex® to support drug development and registration efforts in the USA.
EMD-RX5 is estimated to have more than twice the bioavailability of other Australian CBD products with published pharmacokinetic data.
It also showed lower drug concentration variability between participants, meaning EMD-RX5 has more predictable dosing characteristics – fewer 'highs' and 'lows' recorded.
The results bolster Emyria’s plans to expand its program to register multiple breakthrough solid dosage forms of ultra-pure CBD with the TGA and FDA.
Emyria’s S3 TGA registration program for EMD-RX5 now advances to pivotal Phase 3 clinical trials following planned receipt of ethics approval.
“Highly favourable drug delivery”
Emyria managing director Dr Michael Winlo said: “These pharmacokinetic data show Emyria has rapidly developed a unique, ultra-pure cannabidiol capsule with excellent safety and tolerability and highly favourable drug delivery and absorption characteristics.
“Compared to Epidyolex, the sole CBD-only medicine registered with the TGA and FDA, EMD-RX5 provides equivalent total drug exposures over 24 hours with a more predictable and sustained drug release.
“These results confirm EMD-RX5’s suitability as a multi-indication treatment of chronic conditions and support Emyria’s initial over-the-counter drug registration program targeting the symptoms of psychological distress.
“EMD-RX5 was also shown to provide more than twice the bioavailability of other, plant-derived CBD products in Australia with published pharmacokinetic data, helping further differentiate Emyria’s growing ultra-pure cannabinoid drug development and global registration programs.”
Next steps
EMD-RX5 will now advance to pivotal Phase 3 clinical trials to support the TGA registration of EMD-RX5 as an over-the-counter (OTC) treatment for the symptoms of psychological distress.
Psychological distress affects 15% of the adult population but has no OTC treatment available.
EMD-RX7, targeting prescription-only high dose CBD indications, begins production for Phase 1 trials next quarter and further proprietary ultra-pure cannabinoid-based dose forms are in planning guided by the Australian Emyria Clinical e-Registry (AECeR) co-created with patients cared for at its subsidiary – Emerald Clinics.
The company continues to advance planning to pursue FDA registration targets in addition to exploring partnerships that can accelerate benefits to patients and create shareholder value.