AFRRI begins government-funded Entolimod radiation injury study

Valion Bio, Inc. (Nasdaq: VBIO) announced that the Armed Forces Radiobiology Research Institute (AFRRI), under a contract with the National Institute of Allergy and Infectious Diseases (NIAID), has initiated a U.S. government-funded program evaluating Entolimod as a treatment for radiation-induced gastrointestinal (GI) injury.

According to the company, Entolimod has been delivered to AFRRI, Institutional Animal Care and Use Committee (IACUC) approval has been obtained, and study animals are being acclimated ahead of dosing. A safety study is planned to begin this week to confirm Entolimod's tolerability in the animal strain AFRRI is using.

A therapeutic study is expected to follow upon successful completion of the safety study, with top-line data anticipated in early fall. That study will use a shielded-mouse model designed to preserve the majority of the animals' bone marrow, allowing investigators to evaluate survival and tissue-recovery effects attributed specifically to GI protection.

A potential prophylactic study has not yet been confirmed and remains subject to written confirmation from AFRRI. Valion Bio said it will provide further information if and when that study is confirmed.

"AFRRI's plan to conduct these studies in rapid sequence underscores the importance and urgency we believe the government places on advancing medical countermeasures for lethal radiation injury," said Michael K. Handley, Chief Executive Officer of Valion Bio.

Entolimod is a Toll-like receptor 5 agonist that has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration. It was developed under the FDA's Animal Rule and remains under an open Investigational New Drug application. The company states the drug has been evaluated in more than 40 studies across thousands of animals, including non-human primates, and in approximately 300 human subjects.

Information in this article is based on a press release issued by Valion Bio, Inc.

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