Tivic Health Systems Inc. (Nasdaq:TIVC), a clinical-stage immunotherapeutics company, today announced it has entered into an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to sponsor and conduct a series of preclinical studies evaluating Entolimod™ for gastrointestinal acute radiation syndrome (GI-ARS).

The program is expected to support Tivic's development strategy for Entolimod™ as a medical countermeasure for acute radiation syndrome (ARS).

Under the agreement, NIAID will fund and conduct GI-ARS studies, the first of which will be performed at the Armed Forces Radiobiology Research Institute (AFRRI). The study is designed to evaluate Entolimod's ability to protect GI tissue and mitigate radiation-induced mucosal necrosis following exposure to lethal radiation doses, an area with limited therapeutic options, and a major driver of mortality in ARS.

The research will begin with mouse models and may advance to non-human primate studies provided the initial studies demonstrate efficacy. These preclinical studies are typically required to support regulatory approval under the FDA's Animal Rule.