DELPOR INC — Department of Health and Human Services SBIR Phase II: 200

Description

The prevalence of Typediabetes is expected to reachbyand according to the Centers for Disease Control and Preventionas many asinU Sadults could have diabetes byIn the lastyearsa new class of drugscalled incretin mimeticshas been used successfully for the treatment of the diseaseIncretin mimeticsincluding exenatidehave a very short half life requiring frequent subcutaneous self injectionsSuch delivery can be invasivepainfulpresent safety issuesand impact the patient s attitude towards medication adherenceMaintaining peptide stability and enabling the sustained long term delivery of exenatide are expected to improve complianceconveniencesafetycostand treatment successThe current long acting formulation of exenatide is for onlyweek and does not allow for medication removal if neededThe goal of the proposed program is to develop a small non mechanicalpassivesubcutaneous implantreservoirwhich will be able to deliver consistenttherapeutic levels of stable exenatide over a period of at leastmonthsThe implant body is made of titanium and it is implanted subcutaneously in the upper arm or abdomen via a trocarwith local anesthetic during a simpleminute in office procedureand without the need for any surgical suturesThe implanted reservoir is fitted at one end with a nanopore membrane fabricated to contain pores with diameters that are approximately twofold larger than the hydrodynamic diameter of the selected drug moleculesuch membrane architecture has been shown to result in zero order release kineticsThe proposed delivery method will eliminate the need for daily or weekly self injectionsBenefits include medication adherencepatient convenienceimproved safety and efficacyand cost effective maintenance therapyFurthermorethe system will allow healthcare providers to quickly remove the medication if neededan important considerationas this class of drugs has been associated with acute pancreatitisThe successful completion of Phase I has resulted in the development of a stable formulation of exenatide at body temperatureand has validated that the selected nanopore membrane is not subject to biofouling when exposed to in vivo conditions and is robust enough to advance into preclinical studiesproduct developmentand clinical testingOur proposed work in Phase II will introduce and validate additional peptide analyticsoptimize and validate the nanopore membrane manufacturing processdesign and fabricate a clinical device and implanter toolcomplete the preclinical proof of conceptand prepare a briefing package in order to conduct a pre IND meeting with the FDAThe Company has already received feedback from the FDA on a similar implant for its lead moleculeUpon successful completion of the proposed studyDelpor will be ready to further advance the proposed product into the IND phaseSuccessful completion of the Phase II aims will also allow us to potentially extend the duration even furtherand explore using the same technology for the delivery of other biologicse gbasal insulinhuman growth hormoneoctreotideobesity peptidesetc