Gaithersburg, MD – June 21, 2023 – Cerium Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation (ODD) for Corticotropin (ACTH) porcine (synthetic), otherwise referred to as SNP-ACTH (1-39) Gel. This investigational agent is in development for the treatment of primary membranous nephropathy (PMN) a rare kidney disease that affects approximately 75,000 patients in the US.
“Currently, there are no approved therapies for PMN and limited treatment options. The FDA’s orphan drug designation for Corticotropin (ACTH) porcine (synthetic) acknowledges the need for new therapies in PMN and we believe the therapeutic effects of our product will substantially and safely improve PMN patients’ lives” said Bob Rubin, M.D. Cerium’s Chief Medical Officer. “We are excited to advance our clinical development program into our Phase 3 clinical study.” (Study Record | Beta ClinicalTrials.gov)
The active ingredient in Corticotropin (ACTH) porcine (synthetic) is a synthetic version of a porcine derived 1-39 amino acid adrenocorticotrophic hormone (ACTH). ACTH is a polypeptide tropic hormone produced and secreted by the anterior pituitary gland. ACTH is released in response to the release corticotropin-releasing hormone (CRH) by the hypothalamus. The primary function of ACTH is to stimulate the production and release of cortisol which helps your body manage stress.
Cerium Pharmaceuticals, Inc. is a clinical stage pharmaceutical company dedicated to the development and commercialization of medicines for patients with rare (orphan) diseases. Cerium is currently focused on developing the first drug approved for PMN.