Avecho Biotechnology Advances Phase III Insomnia Trial to Full Enrolment Size

A review of interim data from Avecho Biotechnology’s (ASX: AVE) Phase III trial evaluating its TPM (tocopheryl phosphate mixture)-enhanced cannabidiol (CBD) soft-gel capsule to treat insomnia has recommended the trial be advanced to its originally planned enrolment size.

The Data Monitoring Board (DMB) found that no serious adverse events were identified across the first cohort of 244 participants using 75 milligram or 150mg doses of the soft-gel capsule or placebo over an eight-week treatment period.

Consisting of independent experts in sleep medicine, clinical safety, and biostatistics, the DMB is the only body with access to unblinded trial data.

The group unanimously recommended Avecho’s trial continue to the full planned enrolment of 519 participants.

Value-Inflection Point

Avecho chief executive officer Dr Paul Gavin said the interim analysis represented a major value-inflection point for the trial, reducing clinical development risk and providing a defined pathway toward completion.

“The DMB’s recommendation carries a clear message [that] the treatment effect and variability of data are tracking closely with the assumptions this study was built around,” he said.

“We have always said this trial’s design — which includes two independent endpoints, stringent inclusion and exclusion criteria and controls on the placebo effect — would be a great strength in giving our product the best chance to show its effect and the positive DMB recommendation vindicates that approach.”

Avecho will now commence preparations with its existing clinical site network for the recruitment of a second patient cohort over the next 12 months.

Additional sites have been engaged to support accelerated recruitment, with protocols, site activation procedures, and patient management processes refined during the interim phase being incorporated into the completion plan.

The company intends to fund the work primarily through regional licencing agreements.

Commercialisation Focus

The DMB’s approval has shifted Avecho’s focus towards commercialisation of the new drug.

“We are now considering how this product is positioned against the medicines people currently rely on for sleep,” Dr Gavin said.

“Many existing prescription treatments carry well-documented limitations including next-day impairment and the risk of overdose—concerns not shared by cannabidiol’s safety profile.”

“A treatment that can improve sleep without that safety burden has a clear place in the market and will be central to our ongoing licencing discussions.”

Avecho recently licensed the Australian commercial rights to its CBD TPM capsule to Swiss generic pharmaceuticals developer Sandoz Group under a 10-year agreement that includes a $4.34 million upfront payment, potential development and commercial milestones of up to $23m, and tiered royalties on future sales.