AKSTON BIOSCIENCES CORPORATION — Department of Health and Human Services SBIR Phase I: 200

Description

DESCRIPTION provided by applicant Akston Biosciences Corp is developing a subcutaneously administered therapeutic for preventing or delaying the onset of diabetes in pre diabetic patients who are at high risk those who display autoantibodies for insulin GAD IA and ZnT for developing Type diabetes T D The therapeutic is designed to delete a subset of B cells that likely play a role in disease development using a patientandapos s own macrophages The work covered in this submission builds on preliminary results obtained from both in vitro cell culture and in vivo rodent models Before entering into preclinical development however Akston seeks to identify the best therapeutic regimen in a one month study in NOD Tg mice followed by a more extensive eight month study in wild type NOD mice to demonstrate statistically significant prevention of diabetes in treated animals Doing so will provide critical andquot proof of conceptandquot data and will lead to detailed preclinical IND enabling safety and efficacy work and eventually clinical testing of the therapeutic in man The impacts to public health as a result of this project are potentially significant Healthcare costs directly attributable to T D patients currently account for nearly $ billion annually In addition to the million Americans who currently live with T D new T D patients are diagnosed each year with the rate of newly diagnosed patients andlt years of age increasing by in just the past decade If successful Akstonandapos s therapeutic could lead to a significant reduction in health care costs and possibly free pre T D children and teenagers from a lifetime of glucose monitoring and insulin injections PUBLIC HEALTH RELEVANCE Akston Biosciences is developing AKS which is intended to be a subcutaneously administered therapy for delaying or preventing Type diabetes T D new T D patients are diagnosed every year adding to the pool of million Americans who currently live with T D Akstonandapos s therapeutic strategy is to intervene in at risk pre diabeti patients to remove the problematic cells that may be responsible for T D thereby lowering the chances of patients converting to diabetes Doing so could lead to a significant reduction in the nearly $ billion in annual health care costs attributed to the disease and potentially free pre diabetic patients from a lifetime of T D and its complications