Acer Therapeutics and Relief Therapeutics announce receipt of notification

NEWTON, MA and GENEVA, October 3, 2022 (GLOBE NEWSWIRE) — Acer Therapeutics Inc. ACER (Acer) and RELIEF THERAPEUTICS Holding SA (RLFRLFTF RLFTY)) (Relief) announced today that the United States Patent and Trademark Office (USPTO) has issued Acer with a statement of acceptance of US Patent Application No. 16/624,834 for claims relating to a kit containing a therapeutic Combination product comprises or glycerol phenylbutyrate and sodium benzoate. The patent application is licensed to Acer exclusively by Baylor College of Medicine.

“This approval statement expands the patent protection of ACER-001 and adds an additional component to our product expansion strategy as we evaluate how to maximize its potential,” said Jeff Davis, Acer’s chief business officer. “The combination of phenylbutyrate and sodium benzoate was synergistic in removing ammonia in healthy subjects, based on data from a study published in genetics in medicine in 2018.¹ As a result, this combination offers the potential to use lower drug doses of each compound while maintaining equivalent ammonia removal in patients with urea cycle disorders and will form part of our life cycle plan for ACER-001, pending FDA approval in this indication.”

About phenylbutyrate and sodium benzoate
Phenylbutyrate and sodium benzoate are nitrogen-fixing agents used to prevent and treat hyperammonemia in patients with UCDs. Sodium benzoate for oral administration is available at compounding pharmacies and is commonly used as a food preservative, but has not been approved by the U.S. Food and Drug Administration (FDA) or any other regulatory agency as a single agent for the treatment of UCDs. Sodium benzoate in combination with sodium phenylacetate is approved in the US and marketed as AMMONUL^® (Sodium Phenylacetate and Sodium Benzoate) Injection.²

About ACER-001
ACER-001 (Sodium Phenylbutyrate) is being developed for the treatment of various inborn errors of metabolism, including UCDs and maple syrup…