Summary
- Leading biopharmaceutical company Zelira Therapeutics signed an agreement with Emyria Ltd for Autism Observational Trial of HOPE™ products.
- The Trial will collect efficacy and safety data from patients diagnosed with ASD and have been given one or more HOPE™ products.
- The agreement will expand the global commercialisation opportunities for Zelira.
- The Observational Trial data advise the design of possible future clinical trials and will speed up the path to regulatory approval.
ASX-listed leading global therapeutic medical cannabis player Zelira Therapeutics Limited (ASX:ZLD, OTCQB:ZLDAF) owns a rich portfolio of proprietary revenue-generating cannabinoid-based products that have been launched into global markets. The Company is focused on the development of branded cannabis medicines for the treatment of several medical indications.
Zelira Therapeutics has developed the HOPE™ range of products targeting Autism Spectrum Disorder (ASD). HOPE™ products have been launched and are generating revenues in Pennsylvania and Louisiana and Australia. Lately, the Company signed an agreement with Emyria Ltd (ASX:EMD) for Autism Observational Trial of HOPE™ Products.
Zelira’s agreement with Emyria to study HOPE™ Products
On 9 November 2020, Zelira Therapeutics Limited updated the market that the Company had entered into an agreement with Emyria Ltd for an Observational Trial of Zelira’s HOPE™ range of products in ASD patients.
Emyria Ltd is a reputed global leader dealing with the collection and translation of real-world patient data (RWD). It also owns and manages a national network of specialist medical clinics.
As part of the deal, Zelira will receive longitudinal-RWD from Emyria collected from ASD patients who were administered a HOPE™ product. The data would comprise the patient’s efficacy and safety relating to comorbidities, associated medications, information related to dosing and patient responses to HOPE™ treatment (evaluated through standard ASD clinical and behavioural endpoints).
Zelira will pay a fee of A$115,000 to Emyria in two instalments over the first six months, and a subscription fee for each patient enrolled in the Trial, up to a maximum of 150 volunteers. The agreement term is for 12 months with an option to extend the subscription fees on an ongoing basis.
It is noteworthy to mention that this agreement further accelerates global commercialisation opportunities for HOPE™ products.
The partnership with Emyria underpins Zelira’s competitive advantage in developing high-value medicinal cannabinoid products to market, backed by clinical as well as real-world patient data.
Observational Trial of HOPE™ Products
The Observational Trial will collect efficacy and safety data from patients diagnosed with ASD and have been given one or more HOPE™ products.
This Trial will be one of the most extensive medicinal cannabis studies ever conducted for a specific range of products in ASD patients. The study design will increase strategic engagement with major stakeholders in the Autism community and streamline patient access via Emerald Clinics (Emyria’s national network of specialist medical clinics).
Moreover, this focussed method will generate high-quality, real-world patient data (RWD) that will complement Zelira’s existing data-pack for HOPE™ and notify the Company’s global marketing strategy in real-time.
The study data will also aid in the design of possible future clinical trials, lessen the risks and developmental costs, and speed up the path to regulatory approval.
Notably, these efforts will complement and strengthen the latest launch of HOPE™ products across the Australian market.
Zelira’s HOPE™ products for autism
Zelira has two proprietary formulations under the HOPE™ brand - HOPE 1™ and HOPE 2™. HOPE™ products are part of Zelira’s family of revenue-generating medicinal cannabis products.
The products comprise two pharmaceutical-grade proprietary formulations developed as pharmaceutical-grade products targeting ASD as a disease.
Recently, on 27 October 2020, the Company announced the launch of its HOPE™ products in Australia, marking a significant milestone towards the global commercialisation of HOPE™ products. The Australian launch took place after Therapeutic Goods Administration (TGA) added them to the Special Access Scheme (SAS).
In August 2020, the Company launched HOPE™ products under license in the American state, Louisiana in partnership with Advanced Biomedics LLC.
Adding to this, Dr Michael Winlo, Managing Director of Emyria, said-
Bottomline
The agreement with Emyria adds lustre to the launch of HOPE™ in Australia and accelerates global commercialisation opportunities for HOPE™ products. Additionally, the data from the Trial will also expedite the path to patients and accelerate route to regulatory approval.
On 23 November 2020, ZLD shares traded at A$0.077, up by 13.235%.
