Avata planning Phase 3 CBD clinical trial of new formulation SAP-021
Oral capsule cannabidiol being developed as alternative to Epidiolex
Avata Biosciences is gearing up for a Phase 3 clinical trial to test SAP-021, the company’s oral capsule formulation of cannabidiol — commonly abbreviated as CBD — that’s being developed as an alternative to Epidiolex, an oil-based cannabidiol solution that’s approved to reduce seizure frequency in people with Dravet syndrome and certain other forms of epilepsy.
The company is working to raise $110 million to support the trial, which would be launched before the end of 2025Â and finish in 2027.
While Avata did not provide specifics about the trial’s design, the company said that if all goes as planned, it’s hoping to get SAP-021 approved by the U.S. Food and Drug Administration (FDA) by 2028. The goal would be to bring the therapy to market that same year, according to a company press release.
“With our eye on a full pipeline to include focal epilepsy, schizophrenia, and other neurological diseases, we intend to commence the next stage of clinical development for SAP-021,” said Rupert Haynes, Avata’s CEO.
SAP-021 showed positive results in a Phase 1 trial, supporting the planned “pivotal” Phase 3 study, according to Avata.
Phase 3 clinical trial of CBD formulation would launch in 2025
Cannabidiol, often called CBD for short, is one of the main biologically active agents found in the cannabis plant. CBD isn’t psychoactive, meaning it doesn’t induce a so-called high feeling, but it has been found to have a range of other effects in the body — including anti-inflammatory and anxiety-relieving properties.
Clinical trials have shown that CBD treatment could reduce seizure frequency in conditions like Dravet syndrome, paving the way for the FDA approval of Epidiolex in 2020. Epidiolex was developed by GW Pharmaceuticals, which is now owned by Jazz Pharmaceuticals.
SAP-021 contains a novel synthetic formulation of cannabidiol in a capsule form. According to Haynes, the new formulation allows easier manufacturing on a large scale.
Avata is planning to seek approval of SAP-021 through the FDA’s 505(b)(2) regulatory pathway, which includes mechanisms for approving a new drug whose active ingredient has been shown to be identical to that of an approved therapy.
Avata, which was previously called Sapient Therapeutics, recently announced results from a Phase 1 study (ACTRN12623000730606) that compared the pharmacological properties of SAP-021 against Epidiolex in healthy adult male volunteers. The company did not disclose specific findings in its announcement, but said the trial had met all of its objectives, justifying further development of this formulation. Avata has submitted the Phase 1 results to the U.S. regulatory agency for review.
“Based on the positive Phase 1 data submitted to the FDA for review, we remain committed to a rapid development timeline via the 505(b)(2) FDA regulatory pathway,” Haynes said.
About the Author
