Avecho Biotechnology (ASX: AVE) has embarked on a journey in the hope to treat insomnia, a prevalent sleep disorder affecting millions worldwide. The Australian biotechnology company has initiated patient recruitment for its pivotal Phase III clinical trial, testing an innovative oral cannabidiol TPM®-enhanced soft-gel capsule designed to address insomnia effectively.
The trial is considered the largest of its kind, and aims to enroll 519 patients across various sites throughout Melbourne, Sydney, Central Coast, Brisbane, and Perth. Participants will receive nightly doses of Avecho’s proprietary oral cannabidiol capsules, comparing 75mg and 150mg doses with a placebo over an 8-week period.
Designed to meet stringent regulatory standards set by global authorities like Australia’s Therapeutic Goods Administration (TGA), the trial seeks to establish the efficacy of Avecho’s enhanced cannabidiol formulation as a registered pharmaceutical medicine for insomnia treatment.
With the TGA’s decision to allow over-the-counter sales of registered oral cannabidiol products, Avecho is in a good spot. The company aspires to become the first to gain approval for its oral cannabidiol TPM soft-gel capsule, addressing a significant unmet need in the market.
“This presents an incredible commercial opportunity for Avecho, and we look forward
to first working toward interim analysis results by the end of the calendar year,” Avecho CEO Dr Paul Gavin said.
Avecho’s trial targets eligible participants aged 18 and above, experiencing difficulties with sleep initiation, maintenance, or early awakening for at least three months, and is hoped to potentially offer a breakthrough solution to improve sleep outcomes for millions affected by insomnia.
AVE has been trading at 0.5 cents.