Emyria is focused on developing synthetic CBD-based products to improve the lives of people suffering from conditions ranging from irritable bowel syndrome to mental health issues. High interest is in having high bioavailability allowing for increased absorption of the medicine taken orally.
The company has a library of over 140 proprietary, neurologically active compounds.
OWNERSHIP:
Emerald Clinics is the company’s alternative treatments provider researching 4 different ultra-pure CBD medicines as well as MDMA-based treatments. The company offers ketamine assisted therapy.
CLINICAL TRIALS: Yes.
NEWS & PARTNERSHIPS:
2020
The company announced a global partnership with Sapphire Medical Clinics focused on defining a standardised global Real–World Evidence dataset for patients undergoing therapy with cannabis-based medicines. Sapphire will become Emyria’s preferred clinical service provider in the UK and will provide select, deidentified clinical data for a defined subset of consenting patients.
The company entered a data deal with Zelira and was selected to conduct an observational trial for patients diagnosed with Autism. Emyria will provide Zelira with real-world longitudinal data collected from ASD patients prescribed a HOPE-product.
The company partnered up with Mind Medicine Australia to co-develop a gold-standard and data-driven clinical model for the safe provision of psychedelic-assisted therapies in Australia.
The company signed a real-world data agreement for insomnia drug Zenivol with Zelira Therapeutics where Emyria will monitor the safety and efficacy of Zenivol treatment in patients diagnosed with chronic insomnia to inform Zelira’s path to further development and product registration. The agreement is for 1 year and Zelira can extend the term to capture the required minimum of data for each patient.
The company entered into a clinic trial research agreement for the acceleration of the completion of the Zelira sponsored trial by the company named: “A study to evaluate the safety, tolerability, and pharmacokinetics of a medicinal cannabinoid oil formulation in chronic non-cancer pain participants on long term opioid treatments (Trial ID: ACTRN12619001013156)”
The company partnered with Mind Medicine Australia for the development of a national care program and data registry for psychedelic-assisted therapies. Emyria will design a care model describing how psychedelic-assisted therapies could be delivered safely to patients with major mental health concerns, pending the successful rescheduling of psilocybin and MDMA by the TGA. Mind Medicine Australia will provide access to its international network of experts, clinical trainers and treatment model strategies. The model will start with psilocybin and MDMA-assisted therapies and draw on pivotal research conducted recently in North America and Europe. Emyria will apply its remote monitoring technology and lead the construction of a longitudinal data registry. The registry will collect real world clinical data on diagnoses, concomitant medications, dosing information and patient responses to psychedelic-assisted treatments as measured using validated clinical and patient-reported endpoints. The data will support ongoing research into the safety, effectiveness and cost benefits of psychedelic-assisted therapies for major mental health concerns compared to current alternatives.
2021
The company signed an agreement with Cydelic to collaborate on creating technologies that track psychedelic-assisted patients, Emyria will have a wearable and biometric data from Cydelic’s technology.
The company won a digital health monitoring grant from University of Western Australia worth a total of $880,000 AUD.
The company was selected into Palantir’s Foundry Builders Program, gaining access to the full Palantir Foundry stack.
The company signed a Master Services Agreement with Calvert Labs in support of the company’s TGA and FDA registration programs.
The company signed a letter of intent with Cydelic for cooperation across all of Emyria’s psychedelic-assisted therapy programs to capture unique biometric data that can assist with real-time patient safety and dose response analysis and registration of psychedelic-assisted therapy. The company plans to track EEG’s, heart rate and heart rate variability, activity and sleep, and electrothermal activity and skin temperature using the Cydelic platform. An early goal of the partnership is to develop a deeper understanding of how to implement wearables into psychedelic-assisted therapy in order to build unique and robust real-world data that can assist with safety and efficacy research.
The company received 1,162,134 AUD in R&D tax incentive refund from the Australian government.
The company announced EMDMA-001, a psychedelic-assisted therapy care program targeting PTSD, developed with Mind Medicine Australia.
The company added a suite of Emerald Clinics consulting rooms in Perth co-located with the West Leederville Private Hospital.
The company opened a 2nd Emerald Clinics site in Melbourne, co-located with Victorian Counseling and Psychological Services.
The company won a digital health monitoring grant from Western Australia’s Future Health Research and Innovation Fund allowing for Openly to provide advanced digital and mental health monitoring. The company takes a leadership role e in the grant and will lead a multidisciplinary collaboration involving the state’s major health services and universities. The grant will also extend Emyria’s collaboration with Mt Sinai, New York.
The company entered into an exclusive agreement with the University of Western Australia to develop a drug discovery pipeline of novel psychedelic therapies. The company secured exclusive rights to a library of more than 100 novel MDMA analogues which have been developed by Dr. Matt Piggott. Upon completion of the program, Emyria will have an option to exclusively license the most promising compounds and their associated patent families.
The company engaged AltaSciences for the delivery of a range of proprietary, synthetic cannabinoid-based capsules, targeting registration with the TGA and FDA.
The company received 954,180 AUD in R&D tax incentive refund from the Australian government.
The company entered into a professional services agreement with the Precision Recovery team at New York’s Mt Sinai Hospital to support ongoing development of Emerald’s Openly clinical service. Mt Sinai’s Precision Recovery team will provide remote monitoring and consulting services to support the development and delivery of Emerald’s Openly clinical service worldwide, in exchange for access to the Openly app and a payment for any alert reviewed by the Mt Sinai team on request.
The company partnered with University of Western Australia to develop a drug discovery pipeline of psychedelic therapies. Emyria gained access to the rights of a library of more than 150 compounds close in structure to MDMA targeting PTSD and Parkinson’s Disease.
The company signed a real-world evidence contract with Spectrum Biomedical UK, a subsidiary of Canopy Growth. Emerald will be responsible for the collection of specific data points including de-identified patient information, use of concomitant medicines, prescribed usage and diagnoses, and a range of patient reported outcome measures. These data will then be provided to SBUK to guide and strengthen their treatment development programs. Once the contract has commenced, Emerald will have 24 months to deliver.
2022
The company engaged PsychoGenics to help advance its MDMA-inspired new drug discovery program by lending out the usage of its SmartCube platform which the company and the University of Western Australia, will use by screening 5 novel MDMA analogues from their proprietary library.
The company expanded its MDMA analogue program with the University of Western Australia funding an additional 450,000 AUD to UWA for another year of operations.
The company was accepted into the Preclinical Screening Platform for Pain Program of the NIH HEAL Initiative from the National Institute of Neurological Disorders and Stroke.
2023
The company partnered up with Pax Centre to develop a scalable MDMA-assisted therapy model for patients with complex PTSD as well as a care model for psilocybin-assisted therapy. Emyria will develop the clinical delivery and data monitoring protocols while PAX will provide specialists and trained therapists, and an appropriate facility to administer the therapy safely. Emyria will work on securing patient-ready psilocybin.
The company entered into agreement with Aspen Australia for the licensing and commercialization of EMD-RX5 as an over-the-counter treatment in Australia.
The company acquired the Pax Centre and launched a ketamine-assisted therapy program.
The company was notified that all regulatory permits had been received from Health Canada to start the importation of MDMA.
The company received 2,094,701 AUD in R&D tax incentive refund from the Australian government.
The company secured sufficient clinical-grade MDMA to support MDMA-assisted therapy for over 70 patients after the TGA rescheduling of MDMA comes into effect. The MDMA is facilitated by Mind Medicine and comes from PharmAla Biotech.
The company signed an exclusive binding licensing and commercialization term sheet with Aspen Australia. Aspen Australia will provide funding and resources to support the development and regulatory approvals for EMD-RX5 in Australia. Additionally Aspen Australia will have the exclusive right to market, sell and distribute EMD-RX5 in Australia and Emyria will receive a royalty of up to 10% based on annual net sales and a total of milestone payments amounting to 400,000 AUD.
The company expanded its MDMA library with partner UWA and it now contains over 150 novel chemical entities.
2024
The company received a 500 K USD innovation grant from the Future Health Research and Innovation Seed Fund to advance the company’s MDMA analogue drug development program with the University of Western Australia.
The company entered into a 3-year binding research study agreement with charity Reach Wellness to manage a pivotal observational study designed to evaluate the effectiveness of Emyria’s MDMA-assisted therapy program, together with a support program managed by Reach Wellness, for first responders with PTSD. Reach will subsidize the costs of treatment for an initial cohort of 50 qualified first responders amounting to an estimated total of 1.5 million AUD.
The company received 2,527,316 AUD in R&D tax incentive refund from the Australian government.
The company launched The Empax Centre a state-of-the-art facility dedicated to the delivery and development of new treatments for mental health such as psychedelic-assisted therapies.
The Empax Centre was selected for “IMPACT-2” trial on PTSD.