Three new clinical sites in Sydney and the Gold Coast have joined Avecho Biotechnology's Phase III trial of an oral CBD capsule designed to treat insomnia, with patient screening and recruitment now underway.
The trial is expected to complete dosing for approximately 210 participants by the end of the year, after which an interim analysis will take place, with results anticipated in early 2026. By December 2024, around 70 participants had already received the study medication, and the company is aiming to enrol a further 150 through 2025.
Avecho has also held discussions with its partner, Switzerland-based pharmaceutical company Sandoz, to begin mapping the route to Therapeutic Goods Administration (TGA) registration and commercial launch.
The two companies reached an agreement in March under which Sandoz will pay Avecho an upfront US$3m (A$4.8 million), with a further US$16m (A$25.7m) in development milestones payable if the trial is successful, prior to any commercial sales.
Sandoz will also support patient recruitment efforts and commit to purchasing product from Avecho following registration. Avecho will receive tiered royalties on net sales ranging from 14% to 19%.
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.”
