EQS-News Relief Provides Update on Progress and Plans with ACER-001 for the Treatment of Urea Cycle Disorders
EQS Group-News: RELIEF THERAPEUTICS Holdings AG / Key word(s): Miscellaneous
Relief Provides Update on Progress and Plans with ACER-001 for the Treatment of Urea Cycle Disorders
Geneva, Switzerland, May 18, 2021 - RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF)("Relief"), a biopharmaceutical company with its lead compound RLF-100TM (aviptadil) in advanced clinical development to treat severe COVID-19 patients, today provided an update on the development of ACER-001, a proprietary powder formulation of sodium phenylbutyrate (NaPB) designed to be both taste-masked and immediate release, in the lead indication, urea cycle disorders (UCDs). UCDs are a group of rare genetic metabolic disorders which can lead to an excess accumulation of ammonia in the bloodstream, causing different symptoms such as somnolence, coma, and, in the worst case, may lead to multi-organ failure. Better, more affordable treatment options for UCDs are urgently needed.
Regulatory update U.S.: Relief's partner, Acer Therapeutics, recently announced that it had held a Type B pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA). Acer remains on track to submit an NDA for ACER-001 for the treatment of patients with UCDs in mid-2021, provided that no additional data are requested by the FDA and ongoing development activities are successfully completed (including evaluation of product stability data and reaching agreement on the Pediatric Study Plan (PSP)).
Regulatory update Europe: Relief is responsible for the development and commercialization of ACER-001 in Europe and expects to discuss its plans with the European Medicines Agency this summer. Pending the outcome of these discussions and provided that Acer submits an NDA in the U.S. mid this year as planned, Relief then anticipates submitting a Marketing Authorization Application (MAA) for approval of ACER-001 for the treatment of UCDs in the European Union before the end of 2021.