Tivic Health Systems Inc. (NASDAQ: TIVC) announced it has entered into an agreement with the National Institute of Allergy and Infectious Diseases to conduct preclinical studies evaluating Entolimod for gastrointestinal acute radiation syndrome.

Under the agreement, NIAID will fund and conduct the studies, with the first to be performed at the Armed Forces Radiobiology Research Institute. The study will evaluate Entolimod's ability to protect gastrointestinal tissue and mitigate radiation-induced mucosal necrosis following exposure to lethal radiation doses.

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

NIAID will cover all study-related costs, providing Tivic with access to preclinical development infrastructure without additional capital requirements from the company.

"Government-sponsored development of Entolimod represents an important step forward in addressing a critical gap in the treatment of acute radiation syndrome," said Michael K. Handley, chief executive officer of Tivic Health. "Currently approved therapies primarily target the hematopoietic component of ARS, while gastrointestinal injury remains a significant unmet need."

Current approved acute radiation syndrome therapies include granulocyte colony-stimulating factors such as Neupogen, Neulasta, and Leukine, which stimulate recovery of the hematopoietic system following radiation exposure. These treatments do not directly address damage to the gastrointestinal tract.

Entolimod is a Toll-like receptor 5 agonist that activates NF-κB signaling pathways. The drug has received Fast Track and Orphan Drug designations from the FDA for acute radiation syndrome treatment.