Avecho Biotechnology poised to begin ‘pivotal’ clinical study of proprietary CBD drug in treating insomnia

Avecho Biotechnology (ASX: AVE) is poised to begin “pivotal” phase III clinical studies evaluating its proprietary cannabidiol (CBD) soft gel capsule in treating insomnia.

During the March quarter (Q3 FY2023), Avecho continued development of its products that have been designed with its proprietary Tocopheryl Phosphate Mixture (TPM) drug delivery system.

The company’s TPM drug delivery system enhances the solubility and oral, dermal, and transdermal absorption of drugs and nutrients.

It is derived from Vitamin E using Avecho’s unique proprietary, and patented process.

The upcoming phase III study is assessing Avecho’s TPM-enhanced CBD soft gel capsule.

Avecho chief executive officer Dr Paul Gavin said the trial is a “crucial step” towards gaining regulatory approval for the therapeutic.

“For any biotechnology company aspiring to bring a product to the market, this phase III study is the penultimate step in the clinical development process before seeking regulatory approval, and we’re excited to be on the cusp of this for our CBD-TPM capsule.”

“We’ve spent the last 12 months planning our sleep study, which has been strategically designed to mitigate the placebo effect observed by our peers, and to give our company the best chance at success.”

He said the work the company has put into designing the study, will give it the best chance of a successful outcome.

“This will be a significant milestone for Avecho in Australia, but also has the potential to open doors to new markets and indications globally,” Dr Gavin added.

Phase III study

The upcoming phase III study received formal ethics approval in December last year.

It is set to be the largest randomised, placebo-controlled trial to be carried out in Australia that supports the registration of CBD as an over-the-counter medicine with the Therapeutic Goods Administration.

The study will generate clinical evidence to support registration with other key global regulatory bodies including the United States Food and Drug Administration and the European Medicines Agency.

Avecho noted its elongated efforts into the trial’s planning and design have been highlighted after two peers failed to achieve a statistically significant difference between a placebo and CBD in phase III sleep disturbance studies.

To mitigate any potential damage from the “placebo effect”, Avecho has designed stricter inclusion criteria.

Additionally, the study will be carried out over a longer dosing period and explore higher doses of up to 150 milligrams per day.

Avecho plans to recruit up to 540 participants for the trial and will undertake interim analysis after 300 patients.

The study will be completed across 10 sites around Australia.

Avecho noted the upcoming trial had generated media interest, which highlights the prevalence of insomnia in the community and an urgent need for new treatments.

Capital raising to fund trial

In early April, Avecho launched an $11 million capital raising to fund the trial.

Under an entitlement offer, eligible shareholders can purchase one new share for every share held at a price of $0.006 each.

The offer will also provide three free attaching options for every two new shares subscribed for.

This offer price represented a 33.33% discount to Avecho’s last close of $0.009 prior to the announced raising.

The phase III trial is estimated to cost $12 million and Avecho plans to leverage research and development tax reimbursements to fund its day-to-day operations and any cost over-runs.

Other trials

Avecho has previously partnered with the Lambert Initiative to evaluate a topical CBD-TPM gel for treating osteoarthritis of fingers and hands.

The small phase II study resulted in patients reporting “significant improvements” in pain and grip strength.

These results were presented at the International Cannabinoid Research Society Symposium in June last year and are currently being written up for publication.

The study will now underpin a larger trial with Lambert this year.

During Q3, Avecho announced its collaboration with Lambert would expand beyond topical CBD products.

As Avecho focuses on its phase III study of CBD-TPM in insomnia, Lambert will test its oral CBD product on a number of novel candidate indications that have not been previously associated with CBD therapies.

TPM collaborations

As well as cannabinoid treatments, Avecho is developing using its TPM system with other drug combinations.

In December last year, Avecho announced a partnership with NYSE-listed Perrigo to create a topical TPM-enhanced ibuprofen gel for the US market.

Perrigo plans to carry out a clinical trial using the product in a pain-related indicated this year.

According to Avecho, positive results in the trial would trigger a licencing agreement and continued development of the product for FDA registration.

If successful, Avecho says it could potentially be the first topical ibuprofen product approved in the US.

Under the collaboration, Avecho is managing the products manufacture in Australia, with initial runs to begin shortly.

Another product under development is a TPM-enhanced phytonadione (Vitamin K solution) injectable.

In January, New York-based global biotech Athenex submitted the project for FDA feedback, which will determine future work required to underpin its registration.

Avecho estimates its products will be used across seven clinical trials throughout 2023.

Expanding cannabinoid product portfolio

In the cannabinoid space, Avecho is continuing to develop novel products.

The company is assessing other major cannabinoids, including tetrahydrocannabinol, cannabigerol (CBG), cannabichromene, and cannabinol, in various dosage forms for oral and topical treatments.

These products are undergoing stability testing and a topical CBG formula will best evaluated in a phase II clinical trial with Lambert later this year.

Avecho spent a large part of Q3 optimising a new dosage form – cannabinoid edibles.

The company plans to optimise the manufacture and composition of TPM gummies to maximise absorption.