ACER - Acer Relief report data showing bioequivalence of ACER-001 versus reference drug

Acer Therapeutics (NASDAQ:ACER) and Relief Therapeutics (OTCQB:RLFTF) said data from two phase 1 studies showed that taste-masked sodium phenylbutyrate (ACER-001) was bioequivalent to sodium phenylbutyrate (BUPHENYL(R)) powder under both fed and fasting conditions. The company has filed an application with the U.S. FDA seeking approval of ACER-001 for Urea Cycle Disorders (UCDs). The FDA is expected to make a decision by June 5. The companies presented the data — which evaluated the bioavailability, bioequivalence and taste attributes of taste-masked ACER-001 compared to sodium phenylbutyrate (BUPHENYL(R)) — at the Society for Inherited Metabolic Disorders Annual Meeting. The companies added that higher levels of phenylbutyrate (PBA) and phenylacetate (PAA), a conjugate base of phenylacetic acid, were seen when taste-masked ACER-001 was administered under fasting versus fed conditions. A similar reduction in the PK of sodium phenylbutyrate (BUPHENYL(R)) powder under fed conditions was seen between the fasted and fed studies. Adverse events in the studies showed

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Acer, Relief report data showing bioequivalence of ACER-001 versus reference drug