Avecho Biotechnology’s Phase III clinical trial of its oral CBD capsule to treat insomnia has added three new sites in Sydney and the Gold Coast, with patient screening and recruitment underway.
The trial will complete dosing of around 210 participants by the end of the year, followed by interim analysis, with results expected in early 2026. As of December 2024, approximately 70 participants had received study medication with a further 150 targeted for completion in 2025.
Avecho has also met with its partner, Switzerland-based pharmaceutical giant Sandoz, to start planning the pathway to Therapeutic Goods Administration (TGA) registration and commercialisation.
The two firms struck a deal in March under which Sandoz will pay an upfront US$3m (A$4.8 million) to Avecho and, if the trial is successful, US$16m (A$25.7m) in development milestones ahead of commercial sales.
It will also assist with patient recruitment and purchase product from Avecho after registration, which will also receive tiered royalties ranging from 14% to 19% on net sales.
Avecho CEO, Dr Paul Gavin, said: “The licensing agreement with Sandoz has delivered the capital required to accelerate patient recruitment ahead of our interim analysis — a key milestone in the value development of the program.
“Our priority remains advancing the study to this critical inflection point as efficiently as possible.
“Sandoz’ well-established relationships with patient advocacy groups and the TGA are anticipated to shorten timelines to recruitment and TGA registration.
“We are on the cusp of a major clinical trial milestone for an Australian biotechnology company and attracting this level of support and at such an important time is equal parts rare and deeply exciting.”