Lead therapeutic candidate, VF001 (Investigational)
Factor Therapeutics’ lead therapeutic candidate, VF001, enables and accelerates chronic wound repair by providing cell attachment sites and important growth factors. Cells are able to attach, migrate and proliferate within the extracellular matrix, reinstating a normal wound healing process and reducing pain in the patient.
VF001 is applied to the wound weekly, and fits with standard care for chronic wounds. The wound closes, breaking the cycle of inflammation, and leaving healthy, functional tissue.
A wound to the skin disrupts the extracellular matrix (ECM), tissue that provides structural support for the growth of new cells that is essential for wound repair. Normal wound healing involves an inflammatory process where immune cells are recruited into the wound bed and clean the wound through the release of potent biomolecules. Inflammation quickly subsides to enable new skin cell growth and wound remodelling.
In contrast, chronic wounds remain in a prolonged inflammatory state that leads to damage of critical extracellular components. Effective healing cannot progress without these components of a healthy wound bed. Chronic wounds – such as venous leg ulcers – are painful, significantly hamper mobility and increase infection risk.
Factor Therapeutics’ lead therapeutic candidate, VF001, enables and accelerates chronic wound repair by providing cell attachment sites and stimulating cell activity. Consequently, skin cells are able to attach, migrate and proliferate within the extracellular matrix, reinstating a more “normal” wound healing process. Our clinical experience suggests that this improved healing process also reduces pain and discomfort in many patients.
US Clinical trials
Our primary focus is the completion of a significant US multi-centre Phase II clinical trial. All patients required for the trial have been recruited and we expect to publish the results from the trial in 2019. We will then move into discussions with the FDA around a Phase III program.
Our product is classified by the US Food and Drug Administration (FDA) as a topical biologic drug.
In November 2016, we received notice of removal of clinical hold from the US Food and Drug Administration (FDA) and we are now permitted to proceed with our clinical trial as planned.
Our product is classified by CBER as a topical biologic drug.
EMA CE Mark Submission
Our US Phase II program takes into consideration guidance received from EMA (SAWP) following our withdrawal from the CE Mark process in 2015. The company has a clear vision for resubmission for CE Mark, following the outcome of the US study. Our product is classified by EMA as a Class III Rule 13 (incorporated medicinal product).
Factor Therapeutics has a strong intellectual property portfolio around the use of targeted growth factors, particularly incorporating vitronectin peptides. It is our intention to explore other indications for VF001 in the future, as well as pursue the development of other product candidates that may have unique applicability to other wound care applications, such as surgical and ocular wound care.