FDA Awards Orphan Drug and Rare Pediatric Disease Designations to ImmuneSensor for Lead Drug Candidate
ImmuneSensor Therapeutics, a clinical-stage biotherapeutics company developing innovative cGAS inhibitors for inflammation and autoimmune diseases, announced that the FDA has granted Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) for its lead candidate, IMSB301. This novel oral cGAS inhibitor is being developed to treat cGAS-driven Type I interferonopathy, including Aicardi-Goutières Syndrome (AGS). IMSB301 is also in development for broader inflammatory and autoimmune conditions such as systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE).
FDA Awards Orphan Drug and Rare Pediatric Disease Designations to ImmuneSensor for Lead Drug Candidate