The overall goal of this project is to develop our new stable isotope labeled, version of an existing tuberculosis (TB) drug, isoniazid (INH) for use in treated drug resistant TB. We hypothesize that our that isotope-enhanced compound can be developed into a powerful new drug against INH-resistant TB and multidrug resistant-TB, by addressing the following specific aims:
Specific Aim 1. Determine what other INH resistance-associated mutations [acyl-13C]INH can overcome, and determine the mechanism for why [acyl-13C]INH overcomes the high INH resistance of mutant S315T KatG strains.
Specific Aim 2. Develop an optimized synthesis of our compound and a Technology Transfer Protocol (TTP) for external good manufacturing processes, GMP-capable manufacture.
Specific Aim 3. Collect non-Good Laboratory Practices (GLP) toxicology data on our compound to support subsequent GLP Investigational New Drug (IND) enabling studies. Successful completion of these tasks will pave the way for venture capital funding and transfer of our compound into clinical testing.

Public Health Relevance

. Drug resistant tuberculosis is a fast-growing public health threat worldwide, and currently required lengthy and costly treatment with many side effects. This project addresses a number of key steps in the development of our new compound that is for the improved treatment of drug resistant tuberculosis.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44AI129005-02
Application #
9445394
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Boyce, Jim P
Project Start
2017-03-06
Project End
2019-02-28
Budget Start
2018-03-01
Budget End
2019-02-28
Support Year
2
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Spinceutica, Inc.
Department
Type
DUNS #
080192502
City
Santa Fe
State
NM
Country
United States
Zip Code
87507