Zelira Therapeutics, a biopharmaceutical company with operations in Plymouth Meeting and Australia, is preparing to launch clinical trials for its autism spectrum disorder drug in 2024, writes John George for Philadelphia Business Journal.
The company has adopted an innovative “launch, learn, and develop” strategy to accelerate development while reducing costs.
Instead of following the traditional route of animal testing, Zelira began by introducing Hope 1, a botanical version of its experimental drug, through Pennsylvania’s medical marijuana program. More than 11 million doses of Hope 1 have been safely dispensed. Rigorous observational studies with patients and caregivers have provided valuable insights into dosing, effects, and safety.
Leveraging this data, Zelira developed a synthetic formulation of Hope 1, designed as a capsule, and plans to submit an investigational new drug application to the FDA early next year. If approved, phase 1 trials will begin, targeting autism symptoms such as delayed language, social challenges, and repetitive behaviors.
Zelira has raised over $10 million and seeks an additional $33 million to complete clinical testing by 2027. Chairman Osagie Imasogie said the unconventional approach is the reason for the quick timeline. “The only reason we’re able to move that fast for a relatively nominal amount of money is because we have done the ‘launch, learn and develop’ strategy,” he said
Read more about Zelira Therapeutics and its efforts in cannabis in the Philadelphia Business Journal.
