Emyria Ltd (ASX:EMD) has enrolled 50 patients, screened more than 100 and had nearly 2,000 register their interest in a pivotal Phase 3 clinical trial to support the registration of EMD-RX5 as an over-the-counter (OTC) medicine.
Targeting stress and anxiety
EMD-RX5 is Emyria’s first ultra-pure CBD capsule targeting Therapeutic Goods Administration (TGA) registration as an OTC treatment for the symptoms of mild stress and anxiety for patients with a chronic health condition.
It’s a solid capsule in a preferred dosage form for patients and prescribers.
There is clearly strong patient demand for the OTC trial program, which is on track to complete recruitment by July, with a clinical efficacy read-out anticipated in the subsequent month.
The recruitment and dosing process is expected to accelerate in coming weeks, supported by Emyria’s Emerald Clinics, and with a final two sites – of a total of nine – based in the ACT and SA, to commence dosing this week.
Large potential market
The company expects EMD-RX5 to have a large potential patient market.
Mild anxiety and stress affect up to 15% of the adult population, with a higher prevalence in patients with chronic disease, such as chronic pain, which affects around 2.8 million adults in Australia.
Emyria’s real-world data suggests up to 50% of patients with chronic pain experience anxiety and stress symptoms.
There is currently no OTC treatment for these symptoms and Emyria sees a significant opportunity for EMD-RX5 to address this unmet need.
EMD-RX5 is the only CBD medication targeting the symptoms of anxiety and stress and is aiming to be the first to market.
The company hopes to expand into other markets and indications down the track.
Real-world data
The current market for registered CBD medicine is dominated by Jazz Pharmaceuticals' Epidyolex oil, a prescription medication for rare seizure disorders that generates more than A$1 billion in annual sales globally.
In a head-to-head PK study, EMD-RX5 demonstrated excellent bioavailability, safety, tolerability and lower dose variability compared to Epidyolex oil.
While the TGA has allowed low-dose CBD (lower than 150mg/day) to be registered as an OTC medicine since December 2020, no CBD product has yet achieved this registration.
The asset’s development was based on insights from Emyria's unique real-world data gathered from more than 8,000 patients prescribed pharmaceutical-grade cannabinoid medicines at their clinical service subsidiary, Emerald Clinics.
EMD-RX5 contains no THC or impurities and requires less cost, energy and water to produce than plant-based CBD products.
Emyria’s initial target indication is to treat the symptoms of mild anxiety and stress in patients with a chronic condition.
Phase 3 trial details
The trial has been set up as a multi-site, parallel-arm, randomised, double-blind, placebo-controlled study to investigate the effect of EMD-RX5 on symptoms of psychological distress in adults with chronic pain.
It’s targeting enrolment of 300 participants aged 18-70 with symptoms of stress and a background of chronic pain will be randomised to one month of treatment with either 50mg EMD-RX5, 150mg EMD-RX5 or a matching placebo.
The primary endpoint of the trial is to determine the effect of EMD-RX5 treatment on symptoms of psychological distress in participants with chronic pain through change in self-reported DASS-21 score from baseline to Week 4.