Avecho Biotechnology (ASX: AVE) has announced the start of manufacturing activities to support a pivotal Phase III clinical trial into its oral cannabidoil TPM (tocopheryl phosphate mixture) soft gel capsule for the treatment of insomnia.
US-based contract manufacturing organisation Procaps Group will produce the capsules for the trial, which is scheduled to kick off later this year.
Procaps develops pharmaceutical and nutraceutical solutions, medicines and hospital supplies worldwide and has a direct presence in 13 countries in the Americas.
The company is experienced in the manufacture of pharmaceutical cannabinoid products and is currently producing dronabinol (synthetic tetrahydrocannabinol, or THC) capsules for sale in the US.
Through a small-scale batch production trial organised by Avecho last year, Procaps demonstrated it could manufacture the CBD TPM capsules to the same specifications and performance of the existing product.
Insomnia study
Avecho’s Phase III study will test the capsule for the treatment of insomnia on 540 patients across three treatment groups.
Considered the largest study of its kind to date, it will compare nightly doses of 75 milligrams and 150mg CBD with a placebo over an eight-week period.
Procaps will produce up to 290,000 capsules to support the trial, and also manufacture three registration batches of the CBD capsule which will be placed on formal stability studies to define the shelf life of the commercial product.
Documentation from these batches will form a key component of a package to be submitted to regulatory agencies such as the US Food and Drug Administration (FDA) and Australian Therapeutic Goods Administration (TGA).
Capital raising
Avecho chief executive officer Dr Paul Gavin said the trial would be funded by a recent $2 million capital raising via a non-renounceable entitlement offer to shareholders.
“That offer raised sufficient capital to kick-off the manufacturing activities associated with this Phase III trial,” he said.
“We cannot commence the trial until the investigational product is manufactured, so raising sufficient capital at this point was critical.”
Dr Gavin said Avecho was pleased to be partnering with Procaps Group.
“We are delighted that Procaps will be joining us on this late-stage clinical trial which will be an exciting milestone for the biotechnology industry at large.”
“Importantly for Avecho, Procaps is a manufacturing option for CBD capsules able to be sold in further consumer markets,” he said.
