Synedgen Inc. has completed IND-enabling studies for its lead candidate, MIIST-305, which is being developed for ulcerative colitis and as a medical countermeasure for gastrointestinal acute radiation syndrome. Within a year, Synedgen plans to file an IND application for MIIST-305 and initiate a phase I study to support both programs.
The FDA has awarded orphan drug designation to Neoimmunetech Inc.'s NT-I7 (efineptakin alfa, rhIL-7-hyFc) for the treatment of acute radiation syndrome (ARS). NT-I7, a novel long-acting recombinant human IL-7, has the potential to rapidly recover and improve the immune response following a high dose of radiation exposure.
Ceramedix Holding LLC has been awarded a phase IIB Small Business Innovation Research (SBIR) grant valued at approximately US$3 million by the National Institute of Allergy and Infectious Diseases (NIAID) to support the evaluation of the non-clinical pharmacology of its lead drug candidate. The anti-ceramide antibody is in development through the National Institutes of Health (NIH) as a potential therapeutic to mitigate and/or treat illness due to radiation exposure.
Redhill Biopharma Ltd.'s opaganib hydrochloride (ABC-294640) has been selected by the Radiation and Nuclear Countermeasures Program (RNCP), of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), for the nuclear medical countermeasures product development pipeline as a potential treatment for acute radiation syndrome (ARS).