Framingham, MA – July 16, 2019.  The National Institute of Allergy and Infectious Diseases, an agency of the National Institutes of Health (NIH), has awarded a two-year, $594,008 Small Business Innovative Research (SBIR) grant to Kephera Diagnostics to develop a test-of-cure for Chagas disease, the company announced today.  The Phase I grant will enable the company to develop a prototype of the test and to evaluate its performance on Chagas patients that have undergone treatment. Successful results from this evaluation could lead to further SBIR funding for product development and clinical trials.

Chagas disease, caused by the parasiteTrypanosoma cruzi, is primarily transmitted by an insect called the kissing bug and is endemic throughout most of Latin America.  It is the most prevalent parasitic disease in the western hemisphere, infecting 6-7 million people with over 70 million at risk.   Moreover, CDC estimates approximately 300,000 cases in the U.S., principally among individuals who acquired it in endemic countries, although some autochthonous infections have also been reported. Chagas can also be transmitted congenitally, via consumption of food contaminated by kissing bugs, and rarely by blood transfusion or organ transplantation.  Infection can lead to chronic but typically asymptomatic disease lasting decades, and is associated with a higher risk of death due to cardiac or digestive system impairment.  Treatment for Chagas disease currently relies on two drugs, benznidazole and nifurtimox, the former of which was recently approved by FDA for limited use in the U.S.

Though highly effective when used during acute infection, the drugs’ efficacy decreases in chronic stage disease, treatment can be lengthy, and adverse effects are common and occasionally serious. With current methods, confirming whether a patient has been cured or not is a challenging and protracted process. At present, no test-of-cure is commercially available.  The lack of a test-of-cure has also slowed down the development of new drugs for Chagas disease, as their efficacy can be difficult to measure in clinical studies.

“A straightforward test that would provide a timely indication of whether a patient has been cured of T. cruziinfection or not after treatment is desperately needed, both to improve clinical management of patients and to evaluate new drugs and drug regimens under development” said Dr. Colin Forsyth of DNDi (Drugs for Neglected Diseases Initiative), who is not involved in the grant.

Supported by this grant, Kephera plans to develop a test that will help determine whether treatment has successfully cured a patient’s infection. The test will rely on immune responses to T. cruziantigens selected for their ability to distinguish infected from cured individuals. The test will be translated into both laboratory-based and point-of-care formats to address the needs of clinical and field settings. Kephera scientists will develop the test in collaboration with Infynity Biomarkers (Lyon, France), Vitalant Research Institute (San Francisco, CA) and the Institute of Tropical Medicine at the University of Sao Paulo (Sao Paulo, Brazil).

“This grant adds to our existing work on Chagas diagnosis in a significant way” said Dr. Andrew Levin, Chief Executive Officer of Kephera Diagnostics and Principal Investigator under the grant.  “Developing a test-of-cure fits with Kephera Diagnostics’ mission to address the diagnostic needs and challenges posed by emerging and neglected diseases, of which Chagas has been called the most neglected of the neglected diseases”.

The grant awarded to Kephera Diagnostics is NIH Award No. 1 R43 AI147973.