Medicinal cannabis company Zelira Therapeutics (ASX:ZLD) has announced it has received the fourth tranche of US$681,000 of the US$3.25 million funding to support clinical trials for its proprietary and patent-protected HOPE 1 product.
The funding is managed through a special purpose vehicle (SPV). The receipt of this tranche of funding from the 2011 Forman Trust brings the total funds received via the SPV to US$3.25 million.
Zelira said it continues to manage the SPV as part of its business platform. It said it received "clear and constructive feedback" from the US FDA during the Pre-IND meeting held in July last year.
"The FDA’s official minutes confirmed support for the program and outlined key guidance for the design of the IND-opening Phase 1 study in healthy volunteers," said Zelira, adding that the discussions with the FDA helped it define the study’s target population and endpoints, focusing on treating irritability in patients with Phelan-McDermid Syndrome comorbid with Autism Spectrum Disorder. This represents an important step toward submitting the IND application and initiating clinical trials.
Zelira said it expects subsequent rounds of closings from its continuing fund-raising efforts to support the HOPE 1 formal FDA clinical program.