Perth-based Bone Medical (ASX:BNE) has signed an agreement to acquire US-based medical dermatology company, Botanix Pharmaceuticals.
Botanix is developing new prescription products to treat skin diseases including acne, psoriasis and atopic dermatitis. It has licensed a novel transdermal drug delivery technology known as Permetrex, which is designed to deliver pharmaceuticals through the skin more effectively.
Following the acquisition, and subject to shareholder approval, Bone Medical will change its name to Botanix Pharmaceuticals Limited.
Botanix’s lead product, BTX1503, is a topically applied gel for the treatment of serious acne. BTX1503 utilises a novel pharmaceutical ingredient, which the company says recent studies suggest has a novel 4-part mechanism - reducing excessive production of oils, inhibiting over-proliferation of oil producing cells, inhibiting bacteria and providing a novel anti-inflammatory effect.
Botanix has already completed research and preparatory work on the formulation of BTX1503 and plans to conduct first human clinical studies in Australia.
Botanix says the TGA's Clinical Trial Notification process is significantly more efficient than the US FDA’s Investigational New Drug process, and could accelerate the overall development timetable.
Upon completion of the planned offer, Botanix will be funded to complete initial clinical studies over the next 12 months including a pilot study on patients, through to commencement of a planned Phase 2 efficacy study in the US.
Botanix’s products are based on a FDA grade, synthetic form of a molecule known as cannabidiol, which has been manufactured utilising a proprietary and patent protected synthesis process. Various natural extract and other forms of cannabidiol are in late stage clinical trials by numerous other pharmaceutical companies for indications such as epilepsy, pain and arthritis.
“There is a significant unmet patient need for effective dermatological therapies, particularly in the global acne market. There are few new drug products being developed globally and the potential for novel approaches is very attractive,” said Bone Medical Chairman, Mr Robert Towner.
“We see development of BTX1503 through to human clinical trials, and regulatory approval, as relatively rapid, due to the current stage of development of BTX1503, as well as the unique properties of cannabidiol and its established safety profile.
“There is a growing scientific literature to suggest that cannabidiol has a potential role in treating and preventing skin disease. To date, challenges with the impurity and variability of the drug substance, as well as the challenge of delivering it effectively across the skin, have been limiting. Botanix’s approach of utilising a pure synthetic form of cannabidiol combined with the novel skin delivery technology Permetrex, are focused on solving both of these challenges.”
As part of the transaction, Bone Medical will undertake a consolidation of its capital on a one for three and one third basis and plans to raise $3 million through the issue of 150 million shares at $0.02 each.