Evaluation Of A Novel Connexin-Based Peptide For The Treatment Of Diabetic Wounds

DESCRIPTION provided by applicant According to the ADA million children and adults have diabetes Diabetics have an increased risk of complications such as heart disease and are prone to impaired wound healing A major cause of morbidity and hospitalization is diabetic foot ulceration DFUs that may result in infection gangrene amputations requiring prolonged hospitalization costly treatments and can significantly impair a patientandapos s quality of life The cost of DFUandapos s to the US healthcare system is over $ Billion annually Diabetic wounds tend to remain stalled in the initial inflammatory phase of wound healing and are generally unresponsive to conventional treatments Current treatment approaches including debridement pressure off loading infection control negative pressure and skin substitutes tend to have marginal efficacy and high cost A large unmet need exists for an easier and more effective treatment FirstString Research Inc FSR a clinical stage biotech company is advancing the development of novel bioengineered peptides based on the c terminus of connexin proteins a protein with important roles in multiple aspects of the wound healing process A lead peptide CT amino acids based on connexin Cx has demonstrated a unique capability of switching the bodyandapos s own healing response from inflammation and scarring to a healthy regenerative stage FSR with the assistance of Phase I and II SBIR STTR grants has developed ACT in a topical product called Granexin tm Gel obtained IND approval and demonstrated its MOA safety and efficacy in a Phase I N and two Phase II N per trial clinical trials Granexin tm Gel has been shown to be safe and efficacious with no evidence of immunogenicity FSR proposes to conduct a Phase b human N clinical trial to evaluate safe and efficacy of Granexin tm Gel for treating DFUs This trial will involve grous to receive Granexin tm Gel M CT Standard of Care SOC Granexin tm Gel M CT SOC or Vehicle Gel SOC Due to CT andapos s unique MOA we hypothesize that Granexin tm Gel will significantly accelerate wound closure in DFU patients when compared to Vehicle SOC The hypothesis will be tested through the following specific aims To evaluate the safety and efficacy of Granexin tm Gel administered topically to Diabetic Foot Ulcer The primary endpoint will be the incidence of wound closure from Baseline to Week The secondary endpoints will include mean percent wound closure at weeks subject self assessment of intensity of pain till Week time to and wound closure The safety variable will be the incidence of treatment related Adverse Events Further clinical success achieved with this project will enable the advancement Granexin tm Gel toward pivotal Phase trials obtaining FDAandapos s approval and subsequent product commercialization thus laying the foundation for a novel therapeutic for patients suffering from DFUs PUBLIC HEALTH RELEVANCE Diabetics have an increased risk of complications such as heart disease and prone to impaired wound healing A major cause of morbidity and hospitalization is diabetic foot ulceration DFUs that may result in infection gangrene amputations requiring prolonged hospitalization costly treatments and can significantly impair a patientandapos s quality of life FSR proposes to conduct a Phase b human clinical trial to evaluate safety and efficacy of Granexinandquot Gel for treating DFUs whereby clinical success will lay a foundation for a new treatment option for patients suffering from DFUs