Valion Bio, Inc. (Nasdaq: VBIO), a clinical-stage biopharmaceutical company, has completed formulation work on an oral mucosal version of its investigational drug Entolimod, developed for acute radiation syndrome (ARS), according to a company statement.

Entolimod has historically been administered by intramuscular injection. The new formulation was developed in collaboration with Shear Kershman Laboratories using its proprietary BioViscid™ drug-delivery platform and is designed to enable absorption through the oral mucosa as a needle-free alternative.

The drug candidate is being developed under the U.S. Food and Drug Administration's Animal Rule, which permits drug approvals based on animal efficacy studies when human trials are not feasible or ethical. Published animal studies of injectable Entolimod have shown protection against lethal radiation doses involving both hematopoietic and gastrointestinal tissues. The FDA has granted Entolimod Fast Track and Orphan Drug designations.

Currently, no FDA-approved treatment exists for the gastrointestinal component of ARS. Approved countermeasures address only the hematopoietic component of radiation injury.

"Our goal is to create the ability to administer Entolimod in a more flexible, scalable and field-deployable approach to radiation protection for both military and civilian populations," said Dean Zikria, Interim Chief Executive Officer of Valion Bio.

The company states the oral formulation, if approved, could reduce dependence on trained medical personnel for administration during mass-casualty radiological events. Valion holds an exclusive worldwide license from Statera Biopharma to develop and commercialize Entolimod for ARS and related indications.