By Fineline Cube US-based Acer Therapeutics Inc. (Nasdaq: ACER) and Swiss partner Relief Therapeutics Holding SA (SWX: RLF) announced that China’s National Intellectual Property Administration (CNIPA) has awarded a utility model patent for their drug candidate ACER-001 (sodium phenylbutyrate). The patent, No. ZL202122004991.9, covers the polymer-coated formulation of ACER-001 for oral administration in treating urea cycle disorders (UCDs) and maple syrup urine disease (MSUD), expiring on August 24, 2031.
Drug Profile
ACER-001 is a nitrogen-binding agent developed as an adjunctive therapy for chronic management of UCDs, including deficiencies of carbamoyl phosphate synthetase (CPS), ornithine transcarbamylase (OTC), and argininosuccinic acid synthetase (AS).
Regulatory Update
Acer previously submitted a New Drug Application (NDA) for ACER-001 to the US FDA in 2022 but received a complete response letter due to issues with its contract manufacturer’s inspection availability. The company aims to resolve this by Q3 2024.
Partnership
Relief licensed global development and commercialization rights for ACER-001 from Acer in March 2021 under a deal valued at up to $36 million. The China patent strengthens the drug’s development prospects in the region.-Fineline Info & Tech