Valion Bio, a clinical-stage biopharmaceutical company developing biologics that activate innate immune pathways for cytoprotection and immune modulation, announced that the Armed Forces Radiobiology Research Institute (AFRRI) will be evaluating the therapeutic efficacy of Entolimod. This phase will evaluate whether treatment administered after radiation exposure improves survival in a model designed to assess Gastrointestinal Acute Radiation Syndrome (GI-ARS).

The therapeutic study is fully funded by the National Institute of Allergy and Infectious Diseases (NIAID)/Radiation and Nuclear Countermeasures Program (RNCP) under an Interagency Agreement with the Uniformed Services University (USU)/AFRRI. Top-line results are anticipated in early December.

The decision to advance the program to the therapeutic phase comes just days after Valion announced positive safety results. 

Dean Zikria, Interim Chief Executive Officer of Valion Bio, said, “NIAID’s decision to move into therapeutic efficacy testing at AFRRI gives Entolimod a clear next milestone following the positive safety findings. The central question is now whether treatment after radiation exposure can improve survival in a model designed to isolate gastrointestinal injury. This fully funded study provides an opportunity to evaluate that potential while preserving Valion’s capital and generating critical efficacy data to guide Entolimod towards its next stage of development.”

Entolimod is being developed as a potential medical countermeasure for both the hematopoietic (or bone marrow) and gastrointestinal (GI) forms of acute radiation syndrome. By shielding roughly 2.5 percent of the animals’ bone marrow, the upcoming study’s partial-body irradiation model will enable researchers to differentiate between effects linked to the mitigation of gastrointestinal injury and those associated with recovery.

Mice will receive a single administration of either Entolimod or saline control 24 hours after radiation exposure and then will be monitored for 30 days. The primary endpoint is survival, with outcomes to be compared between the treatment and control groups.

Valion Bio, Inc. is developing biologics that activate innate immune pathways for cytoprotection and modulate immune responses in conditions driven by radiation, disease and immune dysregulation.