Emyria Ltd has engaged leading North American preclinical contract research organisation (CRO) Calvert Labs to conduct a range of preclinical and animal pharmacokinetic, bioavailability and toxicology studies to help rapidly optimise Emyria’s novel, synthetic cannabinoid drug platform.
The market has so far responded well to the news with Emyria shares 2.56% higher to A$0.20 in morning trading.
Calvert will focus on generating preliminary toxicology and pharmacokinetics data enabling human clinical trials for Emyria’s platform to begin.
The appointment of Calvert comes just a week after Emyria aligned itself with leading drug manufacturer Altasciences, to deliver a range of proprietary, synthetic cannabinoid-based (CBD) capsules utilising a unique drug delivery approach. Calvert is an Altasciences company.
"Help strengthen IP"
“We are delighted to be working closely with Calvert Labs, an Altasciences company and world-class preclinical CRO", Emyria’s managing director Dr Michael Winlo said.
“This preclinical work will help strengthen Emyria’s intellectual property relating to our synthetic cannabinoid platform.
"Importantly, this work will help guide the novel formulation, delivery, and dosing strategies of our platform as we prepare our drug development programs for pivotal clinical trials.”
Altasciences has been tasked with conducting complement bioanalysis at its offices in Laval, Quebec.
MSA supports registration programs
Emyria has signed a Master Services Agreement (MSA) with Calvert to conduct preclinical studies to rapidly optimise Emyria’s novel, synthetic cannabinoid drug platform.
The first study is set to start in October.
This study will help Emyria finalise dose formulation prior to commencing EMD-003 pivotal trials, targeting registration with the TGA.
It will also support additional drug development programs pursuing registration with the FDA and other global regulators.
EMD-003 is focused on reducing symptoms of anxiety, depression and stress and is aiming to be a Schedule 3, over-the-counter, low-dose pure cannabidiol drug, which will be the first to make use of Emyria’s proprietary, synthetic dose form.
Calvert’s track record
Calvert has a proven track record of performing FDA-approved studies across a broad range of therapeutic indications.
The company has extensive experience in neurological and psychological diseases and has a large pool of neuropsychopharmacology models to assist in the conduct of complex neuropsychological drug development.
This experience is highly complementary to Emyria’s work with symptoms of psychological distress.
As Calvert is an Altasciences company, Emyria gains further access to integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customisable to specific sponsor requirements.