Relief Therapeutics Holding SA / Key word(s): Study results Acer Therapeutics and Relief Therapeutics Announce Presentation of ACER-001 Data at the NEWTON, MA and GENEVA, SWITZERLAND - May 6, 2022 - Acer Therapeutics Inc. (Nasdaq: ACER) ("Acer") and its collaboration partner, Relief Therapeutics Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) ("Relief"), today announced the presentation of data evaluating the bioavailability, bioequivalence and taste attributes of ACER-001 (sodium phenylbutyrate) compared to sodium phenylbutyrate (BUPHENYL) powder during poster sessions at the recent Genetic Metabolic Dieticians International (GMDI) Conference on May 5, 2022, in Las Vegas, Nevada. "We are pleased to present results from these two studies at another renowned genetic metabolic conference," said Adrian Quartel, MD, CMO of Acer. "These data further support our belief that, if approved, ACER-001 could offer an alternative to current therapies that may lead to meaningful clinical outcomes in patients with Urea Cycle Disorders (UCDs)." "Despite available treatments, there remains an unmet medical need for additional management options for the treatment of UCDs," added Raghuram (Ram) Selvaraju, Chairman of Relief. "We look forward to the Prescription Drug User Fee Act (PDUFA) target action date on June 5, 2022 and potential approval by the U.S. Food and Drug Administration (FDA) of Acer's new drug application for ACER-001 for the treatment of UCDs. Assuming a favorable decision from the FDA, we plan to submit a Marketing Authorization Application in the EU for the product during 2022." ACER-001 Data Presented at GMDI ACER-001: A Potential Alternative to Sodium and Glycerol Phenylbutyrate for Treatment of Urea Cycle Disorders1 The data presented concluded that ACER-001 was bioequivalent to sodium phenylbutyrate (BUPHENYL) powder under both fed and fasting conditions. Higher levels of phenylbutyrate (PBA) and phenylacetate (PAA), a conjugate base of phenylacetic acid, were observed when ACER-001 was administered under fasting versus fed conditions. A similar reduction in the PK of sodium phenylbutyrate (BUPHENYL) powder under fed conditions was observed between the fasted and fed studies. Adverse events in these studies showed no major safety signals and were similar to sodium phenylbutyrate (BUPHENYL). These studies suggest investigating administration of nitrogen scavengers under fasting conditions, which may ultimately provide lower dose options and increase dosing flexibility. Taste-Masked Coating of Sodium Phenylbutyrate (ACER-001) Improves the Palatability of Sodium Phenylbutyrate for Treatment of Urea Cycle Disorders2 The objective of the two taste assessment studies was to identify and quantify the intensity of perceived flavor attributes of ACER-001 relative to sodium phenylbutyrate (BUPHENYL) powder. Results from both studies concluded that ACER-001 was shown to have overall lower flavor intensity scores than sodium phenylbutyrate (BUPHENYL) powder when administered within five minutes of preparation. About UCDs Medications for UCDs are primarily comprised of nitrogen scavenger drugs, which are substances that provide alternative excretion pathways for nitrogen by bypassing the urea cycle.5 The use of these alternative pathways for nitrogen removal is important for the management of acute episodes of hyperammonemia and are also included as part of a long-term treatment regimen for UCDs patients. According to a 2016 study by Shchelochkov et al., published in Molecular Genetics and Metabolism Reports6, while nitrogen scavenging medications are effective in helping to manage UCDs, non-compliance with treatment is common. Reasons given for non-compliance include the unpleasant taste associated with some available medications, the frequency with which medication must be taken and the high cost of the medication. About ACER-001 About Acer Therapeutics Inc. About RELIEF THERAPEUTICS Holding SA RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow Relief on LinkedIn. 1. Steiner R, et al. ACER-001: A Potential Alternative to Sodium and Glycerol Phenylbutyrate for Treatment of Urea Cycle Disorders. GMDI May 2022. 2. Cederbaum S, et al. Taste-Masked Coating of Sodium Phenylbutyrate (ACER-001) Improves the Palatability of Sodium Phenylbutyrate for Treatment of Urea Cycle Disorders. GMDI May 2022. 3. Weiner ID, Mitch WE, Sands JM. Urea and ammonia metabolism and the control of renal nitrogen excretion. Clin J Am Soc Nephrol. 2015;10(8):1444-1458 4. Ah Mew N, et al. Urea cycle disorders overview [updated June 22, 2017]. In: Adam MP, Ardinger HH, Pagon RA, et al, eds. GeneReviews [Internet]. University of Washington; 1993-2022. Accessed March 20, 2022. 5. Häberle J, Boddaert N, Burlina A, et al. Suggested guidelines for the diagnosis and management of urea cycle disorders. Orphanet J Rare Dis. 2012;7:32. 6. Shchelochkov et al. Molecular Genetics & Metabolism Reports 8 (2016) 43-47. Acer Forward-Looking Statements CORPORATE CONTACTS RELIEF THERAPEUTICS Holding SA: INVESTOR RELATIONS CONTACTS Additional features: File: Ad hoc release End of ad hoc announcement |
Language: | English |
Company: | Relief Therapeutics Holding SA |
Avenue de Secheron 15 | |
1202 Geneva | |
Switzerland | |
Phone: | +41 22 545 11 16 |
E-mail: | contact@relieftherapeutics.com |
Internet: | https://relieftherapeutics.com |
ISIN: | CH0100191136 |
Valor: | 10019113 |
Listed: | SIX Swiss Exchange |
EQS News ID: | 1345375 |
End of Announcement | EQS News Service |
1345375 06-May-2022 CET/CEST