Zelira Therapeutics advances autism drug program following FDA meeting

Zelira Therapeutics Ltd (ASX: $ZLD) has made significant progress in its HOPE® autism drug program after a successful meeting with the United States Food and Drug Administration (FDA). The FDA promptly responded to Zelira's meeting request, setting a meeting date for July 10, 2024, and provided a positive and clear written response to preliminary questions. This response clarified essential matters, 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).

Dr Oludare Odumosu expresses enthusiasm for FDA's response

Dr Oludare Odumosu, Zelira Therapeutics Managing Director, expressed the Company's enthusiasm, stating, 'We are particularly pleased with the FDA's prompt and detailed response to our preliminary questions. The clarity provided by the FDA, especially regarding the indication and study design, is incredibly positive for our company and the HOPE® SPV program. This meeting represents a crucial step forward in our mission to develop effective treatments for autism-related irritability.'

Advancement in HOPE® program and future outlook

Zelira Therapeutics (ASX: $ZLD) has achieved a significant milestone in the development of treatments for irritability associated with Autism Spectrum Disorder (ASD) following a successful meeting with the FDA. The positive and clear written response from the FDA, along with the guidance provided during the meeting, has positioned Zelira to progress the HOPE® program toward Investigational New Drug (IND) submission. This advancement marks a substantial step forward in the Company's mission to improve the quality of life for individuals affected by autism. Zelira's commitment to bringing innovative and effective treatments to patients with ASD is reinforced by the collaborative spirit of its CRO team, iNGENu, and the invaluable guidance from the FDA. The Company now eagerly anticipates receiving the official meeting notes from the FDA, which will guide the next steps in the IND submission process. Zelira's future outlook is focused on advancing the HOPE® program and the positive impact it will have on the lives of many individuals affected by autism.