Shareholder Update Q3 2018
-- Venous leg ulcer Phase 2 trial on track: top-line results mid-November -- Diabetic foot ulcer pilot clinical study: in development with key US researchers -- Ocular wounds: international patent applications filed -- Ocular orphan drug designation application: 2018 submission on track
BRISBANE, Australia, Oct. 01, 2018 (GLOBE NEWSWIRE) --
As the key milestone of completing our Phase 2 clinical trial (VF00102) of VF001 for venous leg ulcers (VLU) approaches, I would like to take this opportunity to update you on the full breadth of our research and development activity. While much time and effort has been directed towards VLU, we have made excellent progress elsewhere, maintaining a cost-efficient approach to early stage programs.
VLU key milestone: top-line phase 2 data mid-NovemberThe last VF00102 treatment visit is expected in the coming week, triggering final data cleaning before results analysis. Top-line results, expected mid-November, are a major milestone for the company and our approach has been to “plan for success”. With our underlying technology and precision medicine clinical development strategy, VF001 is a potentially major advance in wound care and positive readout would deliver, for the first time in some years, sound clinical evidence for an innovative wound healing treatment.
New indication – diabetic foot ulcers – poised for clinical decisionIf VF001 benefits VLU there is a clear argument to evaluate diabetic foot ulcers (DFU). DFUs are another common chronic wound and major unmet need associated with significant ill health, high amputation rates and early death; all reflected in a market size for advanced DFU wound care treatments at least double that of VLU.
Working with US key opinion leaders, we have defined key parameters for a pilot clinical study and parallel, focused preclinical program testing VF001 in DFU. This complementary information will identify the most appropriate patients for treatment and form the basis for future decisions regarding larger clinical studies. Building on our VLU experience, the program will be accelerated and potentially doubles, or more, the VF001 commercial opportunity.
Pipeline: ocular worldwide patents filed, lead clinical molecule testingPositive VF00102 data will also support our targeted growth factor delivery platform technology, opening new avenues to explore further applications in wound healing and skin conditions.
Our ocular program is evaluating three candidates for future clinical testing: VF001 (i.e. our lead molecule currently in Phase 2 for VLU), VF003 and VF004 – both new molecules. 2017 saw provisional patent filing for persistent corneal epithelial defect (PCED), an uncommon (orphan) chronic eye wound with potentially serious consequences. In 2018, further in vivo experiments data have enabled international patent applications under the Patent Cooperation Treaty; an Orphan Drug Designation application, to be submitted this year and with a high likelihood of success; and preparation for scientific publication.
Expanding into new and important conditionsHarlequin ichthyosis (HI) is a rare, life-threatening condition in which the skin lacks normal structure and protective function. We have completed Year 1 of a two-year collaboration with Monash University researchers, evaluating an animal model of HI. While deciding not to proceed further, Year 1 outcomes have contributed to the VF00X program.
As the source of our future pipeline and intellectual property, VF00X is building long-term company value. Our researchers are refining our platform technology; identifying targets and new molecules for wound healing, skin conditions and other applications. VF00X has generated a broad panel of constructs, with the current focus on identifying key structural elements within our vitronectin-based scaffold.
Coming monthsAs well as successfully pushing clinical and pipeline projects forward, we are driving the next stage of Factor’s journey: preparing to share Phase 2 results in partnering discussions, finalising the EU CE Mark dossier and refining Phase 3 plans to discuss with the US Food and Drug Administration.
It’s particularly pleasing to note that we have already had a significant impact, with high levels of anticipation of the coming results within the wound care arena. If the clinical readout is successful, the future of the company is very exciting.
Thank you for your continued support; I look forward to sharing the VF00102 results in the near future.
Dr. Rosalind WilsonCEO
Contact for Further Information:Dr. Rosalind Wilson Chief Executive OfficerFactor Therapeutics Limited firstname.lastname@example.org
About Factor TherapeuticsFactor Therapeutics Limited (“Factor”) is a biomedical technology company that is developing treatments for acute and chronic wound healing applications. Factor is a clinical stage company with its lead program (VF001) in Phase 2 for the treatment of venous leg ulcers (VLU). The company is also developing solutions for a variety of interventional wound care and serious orphan dermatology conditions. The company’s platform technology originates from the Institute of Health and Biomedical Innovation at the Queensland University of Technology (QUT), Australia. Factor’s shares are traded on the Australian Securities Exchange (ASX) under the ticker FTT. For more information, please visit https://factor-therapeutics.com