EXTEND BIOSCIENCES INC — Department of Health and Human Services SBIR Phase I: 200

Description

Project Summary Insulin replacement therapy has saved numerous lives of Type diabetic patients since it was established in the andapos s Currently multiple fast intermediate and longer acting insulins are available to patients However many patients on insulin replacement therapy do not achieve adequate blood glucose control as indicated by not reaching target HbA c levels andlt Inter and intra patient variability is a major factor limiting the effectiveness of basal insulin therapy this variability enhances the likelihood of hypoglycemia and reduces the dose of insulin that may be safely prescribed An insulin therapy that is more convenient and less likely to induce hypoglycemia would lead to greater patient compliance Thus methods to deliver a flatter more even dose of insulin with smaller variability and in a convenient format to increase compliance has the potential to significantly improve glycemic control in diabetes patients Extend Biosciences is harnessing the bodyandapos s own natural systems to extend the half life and increase the bioavailability of peptides following subcutaneous injection In this Phase I SBIR grant we propose to develop an ultralong acting version of insulin using our technology and formulate it as a slow release depot to achieve a once weekly basal insulin replacement Preliminary results show that our technology confers a longer half life and increased bioavailability without affecting the function of insulin at the insulin receptor We propose to establish the feasibility of a once weekly basal insulin for the treatment of diabetes by achieving the following three specific aims First we will prepare three depot delivery methods with our long acting insulin Then we will test these formulations in a rat model of type diabetes We will also examine the pharmacokinetics of these formulations in minipigs an animal model that is more predictive of behavior in humans Once fully developed this insulin derivative would greatly benefit patients with diabetes by helping them manage their disease using a long lasting patient friendly drug More even dosing would lower the risks of hypoglycemia while improving control of blood glucose thus reducing long term diabetic complications such as cardiovascular disease retinopathy neuropathy gastroparesis and nephropathy PROJECT NARRATIVE Type diabetes is a classic hormone deficiency disorder that affects a large portion of the population Untreated or inadequately treated diabetes leads to severe complications and is life threatening Extend Biosciences is developing a long acting insulin replacement therapy that the patient can self administer at home far less frequently than current therapies