Zelira executives believe they have a quicker and less expensive path to get their new drug approved.
Zelira Therapeutics is working to begin human clinical testing of its experimental autism spectrum disorder drug next year, but it is not traveling the route pharmaceutical companies typically take to advance a lead product candidate.
The 5-year-old drug development company with operations in Plymouth Meeting and Australia believes it has figured out a quicker and less expensive path.
Zelira is focused on developing treatments using cannabinoids, a class of compounds found in cannabis plants that interact with specific receptors in the central nervous system. The company believes it will be able to bypass the standard process of starting with preclinical studies in animals that contributes to the lengthy timeline and hefty price tag that accompany development of new medicines.
“We call it our ‘launch, learn and develop’ approach,” said Osagie Imasogie, Zelira’s chairman.
Here’s the strategy:
Launch: A botanical version of Zelira’s experimental treatment is already being used through Pennsylvania’s medical marijuana program. More than 11 million doses of that product, called Hope 1, have been safely dispensed in the state, Imasogie said.
Hope 1 was developed by Newtown Square-based Ilera Therapeutics, a spinout of Ilera Healthcare, a developer and distributor of medical cannabis also based in Delaware County that is now part of Toronto-based TerrAscend Corp. Zelira was created in January 2020 through the merger of Ilera Therapeutics and Australia-based Zelda Therapeutics.
Learn: Zelira has conducted what it calls “rigorous observational studies with patients and their caregivers” to learn about Hope 1 dosing frequency, positive effects and side effects.
The company, Imasogie said, conducted similar studies in Australia with physicians who were treating autism spectrum disorder patients with Hope 1 in their normal clinical practice.
Develop: Zelira used what it learned from those studies to develop a synthetic formulation of Hope 1 and create an outline for a clinical trial proposal for the product. The company had several positive interactions with the Food and Drug Administration during the pre-investigational new drug application process, according to Oludare “Dare” Odumosu, Zelira’s CEO.
H/T: www.bizjournals.com
