Akston 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, GAD65, IA-2, and ZnT8) for developing Type 1 diabetes (T1D). The therapeutic is designed to delete a subset of B-cells that likely play a role in disease development using a patient?s own antibody directed cell cytotoxicity machinery. The work covered in this submission builds on Phase 1 SBIR results obtained from mouse models of T1D. Before entering into the IND stage, however, Akston seeks to develop a clinically-acceptable manufacturing process, evaluate safety in rodent and non-human primates, and confirm the therapeutic performance with human cells obtained from T1D patients. Doing so will provide a critical risk reduction to justify further 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 T1D patients currently account for nearly $15 billion annually. In addition to the 3 million Americans who currently live with T1D, 30,000 new T1D patients are diagnosed each year, with the rate of newly diagnosed patients < 20 years of age increasing by 23% in just the past decade. If successful, Akston?s therapeutic could lead to a significant reduction in health care costs and possibly free pre-T1D children and teenagers from a lifetime of glucose monitoring and insulin injections.

Public Health Relevance

Akston is developing AKS-107, which is intended to be a subcutaneously administered therapy for delaying or preventing Type 1 diabetes (T1D). 30,000 new T1D patients are diagnosed every year, adding to the pool of 3 million Americans who currently live with T1D. Akston?s therapeutic strategy is to intervene in at-risk, pre-diabetic patients and remove the problematic cells that may be responsible for T1D, thereby lowering the chances of patients converting to diabetes. Doing so could lead to a significant reduction in the nearly $15 billion in annual health care costs attributed to the disease, and potentially free pre-diabetic patients from a lifetime of T1D and its complications.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44DK107099-02
Application #
9255832
Study Section
Special Emphasis Panel (ZRG1-EMNR-W (10)B)
Program Officer
Arreaza-Rubin, Guillermo
Project Start
2015-09-15
Project End
2019-02-28
Budget Start
2017-03-01
Budget End
2018-02-28
Support Year
2
Fiscal Year
2017
Total Cost
$998,123
Indirect Cost
Name
Akston Biosciences Corporation
Department
Type
Domestic for-Profits
DUNS #
078648843
City
Beverly
State
MA
Country
United States
Zip Code
01915