Valion Bio reports positive preclinical safety data for Entolimod and plans fully funded efficacy study
Valion Bio announced that a U.S. government‑funded safety study of its lead ARS candidate Entolimod showed no treatment‑related toxicity in mice. The study, conducted by the Armed Forces Radiobiology Research Institute, used a single subcutaneous dose of 0.72 mg/kg and observed animals for 14 days. CEO Dean Zikria said the results de‑risk the program and enable a fully funded therapeutic efficacy study focused on survival and gastrointestinal recovery after radiation exposure. Entolimod already holds FDA Fast Track and Orphan Drug designations.
Why it matters
The company says the safety milestone clears a key hurdle and positions the program to begin a fully funded efficacy study, which could accelerate development of a medical countermeasure for acute radiation syndrome.
Key facts
- 1The safety study was funded by NIAID/RNCP and conducted by AFRRI under an Interagency Agreement with the Uniformed Services University. finanznachrichten.de
- 2A single subcutaneous injection of Entolimod at 0.72 mg/kg was administered to male C57BL/6 mice, with a saline vehicle control of 0.2 mL. finanznachrichten.de
- 3No treatment‑related toxicity was observed; body weight, CBC and serum chemistry remained comparable to controls (p = 0.1424 for weight). finanznachrichten.de
- 4Dean Zikria, Interim CEO of Valion Bio, said the safety findings represent an important de‑risking milestone and that the next phase will be a fully funded therapeutic study evaluating survival and GI tissue recovery. finanznachrichten.de
- 5Entolimod has received FDA Fast Track and Orphan Drug designations. finanznachrichten.de
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.