Zelira Therapeutics receives funding for FDA trials of cannabinoid drug for ASD

Biopharmaceutical company Zelira Therapeutics has received $8.6 million in funding for the study of its cannabinoid drug for use in patients with autism spectrum disorder, according to a company press release.

With the funds from Cantheon Capital LLC, Zelira will conduct FDA phases 2 and 3 clinical trials of HOPE 1 via a special purpose vehicle (SPV). Through the SPV, iNGENū, a research company specializing in clinical trials for cannabinoid and psychedelic pharmaceuticals, will act as the contract research organization by validating the drug and submitting an FDA Investigative New Drug application, according to the release.

HOPE 1 is a tincture mixed with pharmaceutical-grade olive oil that contains 5 mg/mL each of THC and CBD that is taken sublingually. Previous trials in Australia showed it to improve symptoms of ASD, according to findings published in March 2022.

“Zelira continues to deliver on our unique drug development strategy with the decision to advance HOPE 1 through formal clinical trials and seek FDA approval,” Oludare Odumosu, PhD, managing director of Zelira, said in the press release. “We are pleased to have searched for and selected a world-class specialist research organization, iNGENū, to partner with us to drive the clinical and regulatory activities for what we hope will be a successful clinical trial that results in the U.S. FDA approval of HOPE 1 as a front-line solution for patients living with ASD.”

References:

• Thomas M, et al. HOPE 1 demonstrates improvements in clinical global impression (CGI) in patients with autism spectrum disorder. https://zeliratx.com/wp-content/uploads/2022/04/ZEL040-White-Paper_Hope_FA.pdf. Published March 2022. Accessed Feb. 15, 2023.
• Zelira secures US$8.6 million cornerstone funding for HOPE 1 US FDA clinical trials. https://www.asx.com.au/asxpdf/20230215/pdf/45lmh9nymjt4r3.pdf. Published Feb. 15, 2023. Accessed Feb. 15, 2023.