It has been a busy quarter for Avecho Biotechnology (ASX: AVE) with work focused on its oral cannabidiol (CBD) soft gel capsule targeting insomnia, and the securing of a new agreement to develop an ibuprofen gel enhanced with its proprietary tocopheryl phosphate mixture (TPM) drug delivery system.
During December, the company received ethics approval for a pivotal Phase III clinical trial to test the soft gel capsule.
The trial will be the largest randomised, placebo-controlled study undertaken in Australia to support registration of CBD as an over-the-counter medicine with the Therapeutic Goods Administration (TGA).
It will enrol 540 patients across three treatment groups to compare nightly CBD doses of 75 milligram and 150mg with a placebo over an eight-week dosing period.
The work will aim to produce clinical evidence to support product registration with key global regulatory bodies including the TGA, United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Avecho has already established a single dose absorption profile for the capsule and will collect blood across the study period to establish steady-state CBD concentrations after longer periods of dosing.
Perrigo agreement
Also in December, Avecho announced it had secured an agreement with global consumer packaged goods business Perrigo Company to develop a topical TPM-enhanced ibuprofen gel for the US market.
Perrigo is planning to conduct a clinical trial this year in a pain-related indication using the new drug.
Positive results will trigger a licensing agreement and continued development of the product for US FDA registration.
Avecho said it could potentially become the first topical ibuprofen product approved in the US.
Development work conducted by Avecho has shown that TPM-enhanced ibuprofen gels can increase the transdermal absorption of ibuprofen by up to 200% when compared with commercially-available products such as Nurofen, Fenbid and Ibuleve.
Athenex submission
Post quarter, Avecho announced that global biopharmaceutical company Athenex had submitted its TPM-enhanced phytonadione injectable product to the US FDA for feedback via a pre-investigational new drug meeting request.
If the feedback is positive, Athenex will enter into a product licensing agreement with Avecho and will complete the remaining development work and registration for US commercialisation.
Final commercial terms are yet to be determined.
Phytonadione (Vitamin K1) injections are used to treat bleeding or clotting problems caused by Vitamin K deficiencies, reactions to certain medications, or other medical conditions which lead to blood thinning.
The injections are routinely administered to infants at birth as a prophylactic, providing protection against bleeding.
Financials
During the quarter, Avecho had a net operating outflow of $763,000, including $696,000 in research and development activities.
Avecho continues to manufacture and sell skincare product Vital ET to US-based Ashland Global for use in the personal care industry.
The company received $425,000 from Vital ET sales made since the December quarter.
At the end of the quarter, Avecho had $1.46 million in cash at bank.
Administration and corporate costs were $428,000, while payments to related parties and their associates totalled $53,000.
