Avecho Therapeutics has officially begun recruiting patients for what it describes as Australia's largest and most robust Phase III clinical trial investigating cannabidiol (CBD) for insomnia treatment. The company received ethics approval for amendments to the trial protocol in March 2024, paving the way for patient enrollment across five clinical sites nationwide.
The ambitious study aims to enroll 519 participants across Melbourne, Sydney, Central Coast, Brisbane, and Perth. Patients will receive either 75mg or 150mg doses of Avecho's proprietary TPM-enhanced CBD soft-gel capsules or a placebo, administered nightly over an 8-week treatment period.
Dr. Paul Gavin, CEO of Avecho, emphasized the significance of the trial: "Avecho's pivotal Phase III clinical trial testing our oral CBD TPM-enhanced soft-gel capsule is the largest and most robust trial of its kind assessing cannabidiol's effect on insomnia, and will aim to prove, with meticulous trial design and regulatory compliance, a place for CBD in the treatment of insomnia."
Addressing a Significant Health Burden
The trial targets a substantial medical need, as insomnia affects approximately 60% of the Australian population to varying degrees. The economic impact of sleep disorders in Australia is estimated at $19.1 billion annually, while the global insomnia treatment market exceeds $4 billion.
The recently approved amendments to the trial protocol include measures to improve study efficiency and the addition of new clinical sites, expanding from the original plan to the current five-location approach. These modifications received formal ethics approval in early March 2024 after submission in December 2023.
Trial Design and Preparation
Avecho has been methodically preparing for this pivotal study, working with clinical trial providers and finalizing manufacturing elements for the investigational product. The company has also engaged in discussions with Australia's Therapeutic Goods Administration (TGA), suggesting regulatory considerations are being addressed proactively.
"We are very pleased to complete one of the final steps in our Phase III trial program prior to commencement, with the formal approval of changes that will allow for a more efficient study," Dr. Gavin noted when the ethics approval was announced. "We expect that all of this sets a strong foundation for what will be the largest and most robust Phase III CBD study in Australia thus far."
TPM Technology Platform
A distinguishing feature of Avecho's investigational product is the company's proprietary TPM (Targeted Penetration Matrix) technology, which enhances the delivery of cannabidiol. The soft-gel capsule formulation represents a potential advantage in a field where optimal delivery methods for cannabinoids remain an active area of research.
The company has established a dedicated recruitment portal at cbdinsomniastudy.com for potential participants interested in joining the trial. As the study progresses, it will provide valuable data on both the efficacy and optimal dosing of CBD for insomnia, potentially establishing a new treatment option for this common sleep disorder.
If successful, this trial could position Avecho's CBD formulation as a significant contender in both the Australian and global markets for insomnia treatments, addressing a widespread condition that impacts quality of life and productivity for millions of people worldwide.
