Zelira Therapeutics (ASX:ZLD), a global leader in the development and commercialisation of clinically validated cannabis medicines, has received the fourth tranche of US$681,000 of the US$3.25 million funding for Zelira to conduct FDA clinical trials for Zelira’s proprietary and patent protected HOPE 1 product.
This funding, managed through a special purpose vehicle (SPV), follows the company’s earlier ASX announcement dated 17 August 2023. The receipt of this tranche of funding from the 2011 Forman Trust brings the total funds received via the SPV to US$3.250 million. Zelira continues to manage the SPV as part of its business platform.
Zelira received clear and constructive feedback from the US FDA during the Pre-IND meeting held on 10 July 2024. The FDA’s official minutes confirmed support for the programme and outlined key guidance for the design of the IND-opening Phase 1 study in healthy volunteers.
The discussions with the FDA helped Zelira define the study’s target population and endpoints, focusing on treating irritability in patients with Phelan-McDermid Syndrome (PMS) comorbid with Autism Spectrum Disorder (ASD). This represents an important step toward submitting the IND application and initiating clinical trials. The FDA’s feedback highlights the potential of the HOPE programme to address significant unmet medical needs in patients with ASD and PMS.
Zelira expects to have subsequent rounds of closings from its continuing fund-raising efforts to support the HOPE 1 formal FDA clinical programme.
