Relief Therapeutics Announces PKU GOLIKE Study Results Presentation at SSIEM 2024
Relief Therapeutics announced that interim data from their clinical trial evaluating PKU GOLIKE® will be presented at the SSIEM 2024 Annual Symposium in Porto, Portugal. This study, carried out by the Inherited Metabolic Disorders Unit at Birmingham Children's Hospital, UK, focuses on controlling overnight phenylalanine (Phe) fluctuations in pediatric patients with phenylketonuria (PKU).
The study compares the benefits of PKU GOLIKE to standard amino acid protein substitutes. Preliminary results indicate that PKU GOLIKE reduces blood phenylalanine levels and increases blood tyrosine levels overnight, which could prevent toxic Phe accumulation during prolonged fasting periods. Final results will be reported after ongoing data analysis.
For more information, visit clinicaltrials.gov (NCT05487378).
Relief Therapeutics ha annunciato che i dati preliminari del loro studio clinico che valuta PKU GOLIKE® saranno presentati al SSIEM 2024 Annual Symposium a Porto, Portogallo. Questo studio, condotto dall'Unità di Disturbi Metabolici Ereditari presso il Birmingham Children's Hospital, Regno Unito, si concentra sul controllo delle fluttuazioni notturne di fenilalanina (Phe) nei pazienti pediatrici affetti da fenilchetonuria (PKU).
Lo studio confronta i benefici di PKU GOLIKE con quelli dei sostituti proteici a base di aminoacidi standard. I risultati preliminari indicano che PKU GOLIKE riduce i livelli di fenilalanina nel sangue e aumenta i livelli di tirosina nel sangue durante la notte, il che potrebbe prevenire l'accumulo tossico di Phe durante periodi prolungati di digiuno. I risultati finali saranno riportati dopo l'analisi dei dati in corso.
Per ulteriori informazioni, visita clinicaltrials.gov (NCT05487378).
Relief Therapeutics anunció que se presentarán datos interinos de su ensayo clínico que evalúa PKU GOLIKE® en el SSIEM 2024 Annual Symposium en Oporto, Portugal. Este estudio, realizado por la Unidad de Trastornos Metabólicos Hereditarios en el Birmingham Children's Hospital, Reino Unido, se centra en controlar las fluctuaciones nocturnas de fenilalanina (Phe) en pacientes pediátricos con fenilcetonuria (PKU).
El estudio compara los beneficios de PKU GOLIKE con los sustitutos de proteínas estándar a base de aminoácidos. Los resultados preliminares indican que PKU GOLIKE reduce los niveles de fenilalanina en sangre y aumenta los niveles de tirosina en sangre durante la noche, lo que podría prevenir la acumulación tóxica de Phe durante períodos prolongados de ayuno. Los resultados finales se informarán después del análisis de datos en curso.
Para más información, visita clinicaltrials.gov (NCT05487378).
Relief Therapeutics는 PKU GOLIKE®를 평가하는 임상 시험의 중간 데이터가 포르투갈 포르투에서 열리는 SSIEM 2024 연례 심포지엄에서 발표될 것이라고 발표했습니다. 이 연구는 영국 Birmingham Children's Hospital의 유전 대사 장애 부서에서 수행되며, 페닐케톤뇨증 (PKU) 환자에서 밤 동안의 페닐알라닌 (Phe) 변동을 조절하는 데 중점을 둡니다.
이 연구는 PKU GOLIKE의 이점을 표준 아미노산 단백질 대체물과 비교합니다. 초기 결과는 PKU GOLIKE가 혈중 페닐알라닌 수치를 감소시키고 혈중 티로신 수치를 증가시킨다는 것을 나타내며, 이는 장기간 금식하는 동안 독성 Phe 축적을 방지할 수 있습니다. 최종 결과는 진행 중인 데이터 분석 후에 보고될 것입니다.
자세한 내용은 clinicaltrials.gov를 방문하세요 (NCT05487378).
Relief Therapeutics a annoncé que des données intermédiaires de leur essai clinique évaluant PKU GOLIKE® seront présentées au SSIEM 2024 Annual Symposium à Porto, Portugal. Cette étude, réalisée par l'Unité des Troubles Métaboliques Héréditaires à l'Birmingham Children's Hospital, Royaume-Uni, se concentre sur le contrôle des fluctuations nocturnes de la phénylalanine (Phe) chez des patients pédiatriques atteints de phénylcétonurie (PKU).
L'étude compare les avantages de PKU GOLIKE avec ceux des substituts de protéines classiques à base d'acides aminés. Les résultats préliminaires indiquent que PKU GOLIKE réduit les niveaux de phénylalanine dans le sang et augmente les niveaux de tyrosine dans le sang pendant la nuit, ce qui pourrait prévenir l'accumulation toxique de Phe pendant les périodes de jeûne prolongées. Les résultats finaux seront rapportés après l'analyse des données en cours.
Pour plus d'informations, visitez clinicaltrials.gov (NCT05487378).
Relief Therapeutics gab bekannt, dass vorläufige Daten aus ihrer klinischen Studie zur Evaluierung von PKU GOLIKE® beim SSIEM 2024 Jahressymposium in Porto, Portugal, präsentiert werden. Diese Studie, die von der Abteilung für Erbliche Stoffwechselkrankheiten am Birmingham Children's Hospital im Vereinigten Königreich durchgeführt wird, konzentriert sich auf die Kontrolle der nächtlichen Schwankungen von Phenylalanin (Phe) bei pädiatrischen Patienten mit Phenylketonurie (PKU).
Die Studie vergleicht die Vorteile von PKU GOLIKE mit Standard-Eiweiß-Ersatzstoffen auf Aminosäurebasis. Vorläufige Ergebnisse zeigen, dass PKU GOLIKE die Blutphenylalaninwerte reduziert und die Bluttyrosinwerte erhöht und somit eine toxische Phe-Akkumulation während längerer Fastenperioden verhindern könnte. Endgültige Ergebnisse werden nach der laufenden Datenanalyse bekannt gegeben.
Für weitere Informationen besuchen Sie clinicaltrials.gov (NCT05487378).
- Interim data shows PKU GOLIKE reduces blood phenylalanine levels overnight.
- PKU GOLIKE increases blood tyrosine levels, potentially preventing toxic Phe accumulation.
- Data to be presented at a reputable symposium (SSIEM 2024), increasing visibility.
- Final results pending, creating uncertainty for investors.
- Study is still ongoing, delaying potential market introduction.
GENEVA, SWITZERLAND / ACCESSWIRE / September 2, 2024 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, announced today that interim data from its clinical trial evaluating PKU GOLIKE® will be presented at the Society for the Study of Inborn Errors of Metabolism (SSIEM) 2024 Annual Symposium being held in Porto, Portugal.
The Company-sponsored, randomized, crossover, controlled study was conducted by the Inherited Metabolic Disorders Unit at Birmingham Children's Hospital, UK. This study evaluated the benefits of PKU GOLIKE compared to standard amino acid protein substitutes in controlling overnight phenylalanine (Phe) fluctuations in the pediatric population with phenylketonuria (PKU).
An oral presentation titled "Randomized Investigation to Evaluate PHE Fluctuation After Overnight Fasting in PKU Patients Treated with Prolonged Release versus Standard Amino Acid Protein Substitute," will be presented by Prof. Anita MacDonald, a leading dietitian in inherited metabolic disorders. Preliminary results suggest that PKU GOLIKE reduces blood phenylalanine levels and increases blood tyrosine levels overnight compared to standard amino acid protein substitutes. Should these findings be confirmed, they would demonstrate PKU GOLIKE's enhanced ability to prevent the toxic accumulation of Phe in PKU patients during prolonged fasting periods.
Relief plans to report final and comprehensive study results following the completion of ongoing data analysis.
For more information on this study (NCT05487378), please visit clinicaltrials.gov.
ABOUT PKU GOLIKE®
PKU GOLIKE products are Foods for Special Medical Purposes (FSMPs) for the dietary management of PKU in children and adults. Developed with Relief's proprietary, patent-protected Physiomimic Technology™ drug delivery platform, PKU GOLIKE products are the first prolonged-release amino acid FSMPs, characterized by a special coating that ensures physiological absorption of the amino acids mirroring that of natural proteins, while also masking the unpleasant taste and odor typically associated with amino acids. PKU GOLIKE products are marketed in the U.S. by Eton Pharmaceuticals Inc. under an exclusive license and supply agreement with Relief, in key European markets by Relief, and select countries worldwide through licensing and distribution partners.
ABOUT RELIEF
Relief is a commercial-stage biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety, and convenience to benefit the lives of patients living with select specialty and rare diseases. Relief's portfolio offers a balanced mix of marketed, revenue-generating products, proprietary, globally patented TEHCLO™ and Physiomimic™ platform technologies and a targeted clinical development pipeline consisting of risk-mitigated assets focused in three core therapeutic areas: rare skin diseases, rare metabolic disorders, and rare respiratory diseases. In addition, Relief is commercializing several legacy products via licensing and distribution partners. Headquartered in Geneva, Relief 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.
CONTACT:
RELIEF THERAPEUTICS Holding SA
Jeremy Meinen
Chief Financial Officer
contact@relieftherapeutics.com
DISCLAIMER
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, including its ability to achieve its corporate, development and commercial goals, and other factors which could cause the actual results, financial condition, performance or achievements of Relief to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. A number of factors, including whether the final results will confirm the currently available data from the NCT05487378 study, and those described in Relief's filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission (SEC), could impact the outcome. Copies of Relief's filings with the SEC are available on the SEC EDGAR database at www.sec.gov. Relief does not undertake any obligation to update the information contained herein, which speaks only as of this date.
SOURCE: Relief Therapeutics Holdings AG
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