Valion Bio (NASDAQ: VBIO) has announced that the Armed Forces Radiobiology Research Institute (AFRRI) will evaluate the therapeutic efficacy of Entolimod in a post-radiation treatment model designed to assess whether the drug improves survival in gastrointestinal acute radiation syndrome (GI-ARS).
According to Valion, 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. Achieving this milestone uniquely positions Valion, potentially further strengthening its competitive position, commercial opportunities, and fundamental outlook.
In a statement, Dean Zikria, interim CEO of Valion, commented, “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.”
Evaluating Entolimod’s Potential to Improve Survival Following Radiation Exposure
Entolimod is being developed as a potential medical countermeasure for both the hematopoietic (or bone marrow) and gastrointestinal (GI) forms of acute radiation syndrome (ARS). By shielding roughly 2.5% 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.
Mr. Zikria added, “GI-ARS remains a critical challenge in the development of medical countermeasures. Demonstrating a survival benefit in this model would underscore a novel and clinically significant milestone for Entolimod and further strengthen its potential role as a medical countermeasure for radiation emergencies. We would like to thank AFRRI and NIAID for their continued support and look forward to the results from this key study.”
