Avecho Biotechnology Restarts Final Recruitment Stage for Key Insomnia Trial

Avecho Biotechnology (ASX: AVE) has recommenced recruitment for the final stage of its Phase III insomnia trial evaluating a Tocopheryl Phosphate Mixture (TPM)-enhanced cannabidiol soft-gel capsule.

About 320 additional participants will be enrolled in the second cohort, taking the trial to its originally planned target of 519 participants completing the study.

Recruitment has restarted through existing clinical sites, with additional sites to be progressively activated to accelerate enrolment and support completion of recruitment within about 12 months once those sites are operational.

The restart follows a positive interim analysis in June in which the independent Data Monitoring Board (DMB) unanimously recommended continuing the trial without increasing its planned sample size.

Avecho expects to apply recruitment strategies, site-management processes and operational improvements developed during the first stage as it works through the remaining enrolment.

Final Stage Cleared

The interim analysis used data from 244 participants, with the DMB the only body to have access to the trial’s unblinded treatment and efficacy information.

Avecho remains blinded to treatment allocations and efficacy results, which will not be available until the study has been completed and the final data analysed.

The DMB determined the study had satisfied the pre-specified criteria in the trial protocol and found no serious adverse events among the 244 participants assessed across the three treatment groups.

“The interim analysis was the most significant milestone in this program and, in our view, the single biggest risk to the study,” chief executive officer Dr Paul Gavin said.

“With that now behind us and the trial materially de-risked, we are recommencing dosing of the final cohort of patients, confident we are on the path to a successful completion of this pivotal Phase III study.”

Insomnia Severity Targeted

The Phase III study is a multi-centre, randomised, double-blind and placebo-controlled trial assessing the efficacy and safety of Avecho’s CBD TPM soft-gel capsule in adults with insomnia.

Participants are randomly assigned to receive a nightly dose of either 75mg CBD, 150mg CBD, or placebo over an eight-week treatment period.

Validated questionnaires and daily sleep diaries are being used to measure changes in insomnia severity and sleep quality throughout the study.

The planned 519 completed participants will include the first cohort already assessed at interim analysis and the additional second-cohort participants, with further enrolment allowed to replace withdrawals.

A successful Phase III study would represent Avecho’s final clinical step in support of a submission to Australia’s Therapeutic Goods Administration for pharmaceutical registration of the CBD TPM soft-gel capsule for insomnia management.

Development Program Advancing

Avecho’s lead asset uses its proprietary TPM drug delivery system, which is derived from vitamin E and designed to enhance the solubility and absorption of drugs and nutrients.

The company has previously demonstrated that its CBD TPM soft-gel capsule increases CBD absorption and is now testing the product in its pivotal insomnia program.

Australia’s regulatory framework allows approved CBD products to be sold over the counter through pharmacies without a prescription, creating a potential commercial pathway if Avecho successfully completes development and secures the required approvals.

With recruitment under way again and additional clinical sites being added, Avecho is now focused on completing the final cohort before the study proceeds to final analysis.