Australian biomedical company Factor Therapeutics (ASX: FTT) is expecting “top line results” following the completion of a lengthy Phase 2 clinical trial of its VF001 drug for the treatment of venous leg ulcers.
Based in the United States, the trial – which recorded its “first patient in” milestone in December 2016 – aimed to define the potential clinical benefits of VF001 for patients with serious chronic wounds, and generate sufficient data to trigger meaningful commercial and partnering opportunities.
Venous leg ulcers have been termed “a silent epidemic”, representing a critical burden for patients and health care providers worldwide.
Over 600,000 cases are diagnosed across the US every 12 months, resulting in a loss of approximately 2 million working days and a cost of around $3.5 billion to the US healthcare system per year.
VF001 was developed as a topical treatment to dramatically reduce ulcer size, ease pain and speed healing times, thereby improving overall quality of life for patients.
The VF001 Phase 2 clinical trial involved 168 patients with moderately-severe venous leg ulcers over 26 clinical sites across the US.
It was structured as a randomised, double-blinded, placebo-controlled study in conjunction with standard care such as moisture dressings and compression bandages.
The design featured strict recruitment criteria along with a built-in screening process whereby patients received standard care for the first two weeks of the trial and if spontaneous healing or severe deterioration occurred, were then excluded from proceeding further.
Following the screening period, patients received either a placebo or one of two doses of VF001 for up to 12 weeks and were followed for a further 12-weeks post-treatment.
The primary endpoint of the trial was a reduction in the size of the wound.
Other endpoints included the proportion of patients with full wound closure, time to wound closure, improvements in pain and quality of life, and safety.
Factor chief executive officer Dr Ros Wilson said the VF001 trial was completed satisfactorily and ahead of schedule.
“We’re now only a matter of weeks away from readout and, in the meantime, we are continuing with partnering discussions and preparations for regulatory interactions in Europe and the US next year,” she said.
Dr Wilson expects results to be released in mid-November, following final quality checks and database analysis.
VF001 has been designed as a liquid, topical treatment for chronic wounds based on two naturally-occurring substances involved in wound healing – vitronectin and IGF-1 (insulin-like growth factor 1).
The vitronectin component of the drug binds to the base of the wound, creating a “biological scaffold” to which the skin cells can attach.
IGF-1 provides a signal which stimulates the cells to proliferate and migrate into the wound.
Cell attachment, proliferation and migration are central processes in wound healing.
Factor said VF001 is easy to use – a small volume (0.5 ml) is applied to the wound during routine weekly dressing changes.
If the VF001 drug successfully demonstrates a benefit in the treatment of venous leg ulcers, Factor said there could be a sound clinical basis to evaluate its efficacy for diabetic foot ulcers – also a common type of chronic wound and an area of “major unmet need”.
Diabetic foot ulcers are associated with significant ill health, high rates of amputation and an increased risk of early death.
Data generated from the VF001 venous leg ulcer program could be used for the basis of larger Phase 2 and Phase 3 clinical studies relating to diabetic foot ulcers.
“The program will build on our clinical experience with venous leg ulcers and be accelerated in the process, with the potential to increase commercial opportunities for VF001,” Dr Wilson said.
At mid-morning trade, shares in Factor Therapeutics had dropped 1.25% to $0.079.