Zelira says it advances HOPE autism drug program with US FDA meeting

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Zelira Therapeutics (ASX:ZLD) has announced an advancement in its HOPE autism drug program following a meeting with the US FDA.

Zelira is developing and commercialising clinically validated cannabis medicines.

The company said the FDA's response provided clarity on all matters presented, particularly in defining the indication for treatment of irritability associated with Autism Spectrum Disorder (ASD) in patients with Phelan-McDermid Syndrome (PMS) and Smith-Magenis Syndrome (SMS).

During the meeting, Zelira discussed the design of the IND-opening Phase 1 study in healthy volunteers. The FDA provided guidance on the study design, aiming to evaluate the safety and pharmacokinetics of the proposed doses of ZELHOP1, ensuring a robust framework for further clinical development.

Zelira said that following the positive feedback and productive meeting, it is poised to progress the HOPE program toward Investigational New Drug (IND) submission.