Chronic skin wounds associated with various diseases (e.g., diabetes) and aberrant healing from acute wounding (e.g., hypertrophic scarring) are a major health care burden. This health burden increases in aging populations. The cost to treat these conditions exceeds $25 billion annually. Currently, REGRANEX, a cream containing a biologic based on human PDGF (Platelet-Derived Growth Factor), is the only FDA (Food and Drug Administration) approved biologic to treat diabetic wounds. However, the combination of its modest effect on healing and a black box warning added by the FDA for its cancer risk have not translated its drug efficacy to clinical benefit. These facts highlight the sense of urgency for scientific discovery-based therapeutic interventions. Allander Biotechnologies is developing proprietary topically applied biologics to promote wound healing. During the Phase I funding period of this grant, we have tested several biologics and identified our lead biologic to be further developed in this Phase II application. Our Phase I studies revealed that our biologic has multiple functions needed for wound healing. Our Phase II studies will focus on the process of formulation development for our biologic to be used as a topical drug, and data production that will lead us to a successful path for filing an Investigational New Drug (IND) application to the FDA. We will perform pre-formulation studies for solubility as well as stability of physicochemical characterizations and bioactivities of our drug substance. We will use data generated from pre-formulation studies to guide our formulation prototype development. We will produce our biologic at pharmaceutical grade purity and use it as well as the lead formulation(s) to treat diabetic mouse wounds and pig excisional wounds for efficacy studies to define pharmacodynamics (PD) biomarkers and identify potential acute cutaneous/systemic toxicities. By the end of this Phase II funding, we will have stability and physicochemical profiles of our biologic, the lead formulation, PD biomarkers, and protocols (analytical, bioassay, and toxicology) standardized for generating additional IND data under Good Laboratory Practice conditions.
Chronic skin wounds in diabetic patients and the elderly, affect 6.5 million people in the United States. This application aims to develop a novel biologic that can treat chronic and acute skin wounds by topical application to alleviate immediate suffering caused by skin wounds and prevent long-term wound related sequelae, such as permanent tissue/organ loss or scarring.
