FirstString Research, Inc — Department of Health and Human Services SBIR Phase II: 200

Description

Project SummaryAn estimatedmillion people worldwide have diabetesincluding overmillion AmericansA major cause of morbidity and hospitalization in patients with diabetes is diabetic foot ulcerationDFUwhich can result in infectionamputationprolonged hospitalizationand costly treatmentsDiabetes treatments cost the American healthcare system$billion annuallyrepresentingof the total healthcare expenditureand DFU treatment consumesof these costsChronic diabetic wounds remain stalled in the initial inflammatory phase of wound healing and remain unresponsive to conventional treatmentsCurrent treatment approaches tend to have limited to marginal efficacy and high costA large unmet need exists for safecosteffective therapeutics that are easily applied in the home care or clinical setting and conform to practice of medicine in DFU care without reducing efficacyFirstString ResearchInca clinical stage biopharmaceutical companyis advancing the development of novel bioengineered peptides based on the C terminus of connexin proteinsa protein with important roles in the wound healing processOur lead peptideaCTamino acidsbased on connexinhas demonstrated a unique capability of switching the body s healing response from excessive inflammation and scarring to a healthy regenerative stageWith the assistance of SBIR STTR grants and significant private fundingFirstString has developed aCTin a topical product called GranexingelGranexinobtained IND approvaland demonstrated its mechanism of actionsafetyand efficacy in a PhaseNand three Phaseclinical trialsNTissue injuries treated with Granexin show clinically and statistically significant faster healingreduced inflammationand improved mechanical properties without treatment related adverse eventsFirstString has received Phase IIb SBIR funding to continue clinical development and evaluate the efficacy and safety of Granexin in a larger clinical trial currently underwayDuring the End of Phasemeetingthe FDA requested amonth repeat dose pig study as an integral part of Granexin s NDANew Drug Approvalreview processin line with FDA s Guidance for Industry in the development and approval for chronic wound therapeuticsThe Specific Aim of this CRP SBproject is to conduct a standardweek repeat dose GLP dermal toxicity study of Granexingel in the G ttingen mini pig followed by aday recoverySubaiminvolves the assessment of the safety of repeat topical dosing of Granexin at lowMmediumMand highMconcentrationswith appropriate controlson skin wounds that will be rewounded everydaysSubaimwill involve the toxicokinetic analysis of aCTpeptide and assessment of systemic exposureThis study is similar to our previously conductedday repeat dose toxicity study in pigsSuccessful completion of this aim will fill in a necessary gap in obtaining NDA approval for Granexin from the FDA and support the eventual market launch of Granexin for the treatment of DFUs