Zelira Therapeutics (ASX:ZLD) says it has received the official minutes from the US FDA for the July PreIND meeting for its HOPE autism drug program.
Zelira said that before the Pre-IND meeting, it had already received "clear and positive" written responses from the FDA to its preliminary questions.
The Pre-IND meeting was attended by key stakeholders, including the principals of iNGENu clinical research organisation.
Zelira said the meeting focused on the design of the IND-opening Phase 1 study in healthy volunteers, particularly on defining the target indication and patient population.
"The FDA offered valuable guidance on the study design, emphasising the importance of evaluating the safety and pharmacokinetics of the proposed doses of ZEL-HOP1," said the company.
Zelira said it had defined the study’s target population and endpoints, specifically focusing on treating Irritability associated with Autism Spectrum Disorder in patients with Phelan-McDermid Syndrome.
Dr Rob Jenny, the head of regulatory affairs at iNGENu CRO, said, "We are encouraged by the clarity and guidance provided by the Agency. This feedback not only provides validation of Zelira’s approach but also the confidence to proceed with the next steps in its clinical program. We are excited to continue our collaboration as we move toward IND submission."