Acer Therapeutics Inc (fka ACER)

[PennyWorld]

https://seekingalpha.com/news/3822571-acer-relief-report-data-showing-bioequivalence-of-acer-001-versus-reference-drug

Acer, Relief report data showing bioequivalence of ACER-001 versus reference drug
Apr. 12, 2022 5:56 AM ETAcer Therapeutics Inc. (ACER), RLFTFBy: Ravikash, SA News Editor
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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 no major safety signals.

In addition, the companies noted that results from two phase 1 taste assessment studies concluded that taste-masked ACER-001 was shown to have overall lower flavor intensity scores than sodium phenylbutyrate (BUPHENYL(R)) powder when administered within five minutes of preparation.