Emyria Ltd (ASX:EMD) has started participant recruitment, screening and consenting for its Phase 1 clinical trial of EMD-RX5, with dosing expected to begin by the end of this month.
The study will be a Phase 1, two-way cross-over clinical trial that will assess the safety and bioavailability of EMD-RX5 compared to Epidyolex – the only CBD-only treatment formally registered with the Therapeutic Goods Administration (TGA) and the Food and Drug Administration (FDA) – in 12 healthy human volunteers who will receive both cannabinoid treatments.
EMD-RX5 is an ultra-pure, highly bioavailable cannabidiol (CBD) capsule with potential to become a registered treatment for multiple indications.
Emyria is initially seeking registration of EMD-RX5 with the TGA as a low-dose, Schedule 3, ‘over-the-counter’ CBD treatment for the symptoms of psychological distress.
Targeting unmet psychological distress
“Emyria’s first registration program is aimed at developing an over-the-counter, Schedule 3 treatment targeting the symptoms of psychological distress – a growing global mental health concern affecting about 15% of all adults in Australia alone and which currently has no over-the-counter treatment available,” Emyria managing director Dr Michael Winlo said.
“EMD-RX5 also meets the strict requirements for product purity with both the TGA in Australia and the FDA in the USA, and as such, we believe EMD-RX5 has the potential to become a registered treatment in additional markets and for multiple clinical indications.
“Since the EMD-RX5 clinical development program was developed with insights from Emyria’s growing Real-World Data asset, the company is able to move quickly from Phase 1 through to a Pivotal Phase 3 clinical trial.
“Uniquely amongst cannabidiol registration programs, Emyria’s Phase 1 clinical trial will directly compare the bioavailability of EMD-RX5’s proprietary formulation to the only successfully registered and reimbursed CBD oil in the global market to date, Epidyolex.
“I look forward to providing further updates on EMD-RX5 and our expanding cannabinoid portfolio.”
Emyria has leveraged its proprietary Real World Data pipeline to inform the selection of the treatment’s target indication, which the company believes will not require a Phase 2 study, allowing the pivotal Phase 3 study required for registration to begin immediately once the Phase 1 trial concludes.
About Emyria
Emyria is a data-backed, drug development company that helps pharmaceutical companies to accelerate drug development by pioneering new ways to collect, standardise and analyse dynamic patient data and clinical evidence.
The company’s drug development programs are informed by insights generated from extensive analysis of Emyria Data - deep, ethically sourced clinical evidence that is gathered with patients across its independent clinical services.
Emyria is also engaged in developing new care models for patients with unmet needs by using novel treatments and by bringing together patients, clinicians, researchers and medical innovators.