NIAID starts preclinical trial for NeoImmuneTech's acute radiation syndrome drug

NeoImmuneTech announced that the U.S. National Institute of Allergy and Infectious Diseases (NIAID), a division of the U.S. National Institutes of Health (NIH), has commenced a nonclinical trial to evaluate the efficacy of NT-I7 in treating acute radiation syndrome (ARS).

In December 2022, NeoimmuneTech agreed with the NIAID to research and develop a treatment for ARS.

The agreement with the U.S. government agency was supported by the results of a nonclinical study conducted at Duke University.

The study with Duke University showed that in rodents exposed to high levels of radiation, the natural recovery of T cells to normal levels took approximately three months. In contrast, the administration of NT-I7 resulted in the restoration of T cell levels to normal within a much shorter timeframe of one to two weeks.

"Since the agreement with NIAID, we have held several meetings with the agency to finalize the nonclinical trial design and related preparations and finally decided on starting the study," the company said. "NIAID will cover all costs of the trial and will conduct the study itself, and NeoImmuneTech will provide NT-I7 to NIAID."

NeoImmuneTech CSO Lee Byung-ha, also said, "Due to the nature of ARS, the company can start supplying the product after passing only two nonclinical trials in rodents and primates,"

Once the results are finalized, NeoImmuneTech will begin discussions with the Radiation and Nuclear Countermeasures Program (RNCP) committee and the U.S. Food and Drug Administration (FDA) for primate testing and emergency use authorization (EUA), Lee added.

According to Lee, while the size of the U.S. Strategic National Stockpile product may vary depending on the treatment, the most recent purchase was for 370 billion won ($290 million) worth of Amgen's Nplate, a platelet booster.