NeoImmuneTech, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for their investigational drug NT-I7 (efineptakin alfa) (rhIL-7-hyFc) for the treatment of Acute Radiation Syndrome (ARS).
ARS is an illness that occurs following a high dose of radiation exposure, leading to severe damage to the bone marrow and the immune system. Currently, there are no treatments available that effectively promote T cell recovery after such exposure. NT-I7, a novel long-acting human interleukin-7 (IL-7), is expected to address this unmet medical need, with the potential to rapidly recover and improve the immune response. In the clinical setting, NT-I7 has demonstrated impressive results by effectively and consistently boosting T cell counts, all while maintaining a remarkable level of safety and tolerance.
The FDA’s ODD for NT-I7 reflects progress in the company’s efforts. A contract research organization (CRO) under contract to National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is conducting a study that employs well-developed NIAID ARS rodent models to investigate NT-I7’s efficacy as a potential treatment for the serious health implications of ARS. NIAID is supporting this research through product development funding to the CRO.
Dr. Se Hwan Yang, Ph.D., President and Chief Executive Officer of NeoImmuneTech, Inc., said: “Obtaining the Orphan Drug Designation from the FDA is an important acknowledgment of the immense potential that NT-I7 holds in providing a beacon of hope for the treatment of ARS.”
ODD is a status assigned to a medicine intended for use against a rare disease or condition that affects fewer than 200,000 people in the United States. The designation provides incentives to advance the development of treatments for rare diseases, including protection from competition once the drug is on the market, tax credits for clinical research costs, and exemption from prescription drug user fees.