Avecho Biotechnology (ASX:AVE) has provided an update on its oral cannabidiol TPM-enhanced capsule development program, confirming that all three new sites for the Phase 3 clinical trial have commenced screening and recruitment.
Avecho recently announced that it had licensed the Australian commercial rights to the product to Sandoz.
Avecho said the new sites maintain independent databases of patients with insomnia, providing an immediate and valuable pool of prospective trial participants.
The trial will complete dosing of approximately 210 subjects before conducting a planned interim analysis. As of December 2024, approximately 70 participants had received study medication. Recruitment was paused over the summer to avoid the holiday period but resumed in March 2025, said Avecho. Avecho said it aims to complete dosing for the cohort of patients required for the interim analysis during 2025, with results of the interim analysis available in early 2026.
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. Beyond funding, Sandoz brings deep operational and regulatory expertise, and we are already leveraging this to strengthen execution and enhance the overall potential of the Trial.”
Dr Gavin added, "We are excited to maximise our collaboration with Sandoz and early interactions endorse this company as an ideal development partner. 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.”