Ardelyx Announces Three Abstracts Accepted for Poster Presentations at Digestive Disease Week 2025 Conference
Ardelyx (Nasdaq: ARDX) has announced the acceptance of three abstracts for poster presentations at the Digestive Disease Week Conference (DDW) in San Diego, May 3-6, 2025. The presentations will showcase data on IBSRELA® (tenapanor), their FDA-approved treatment for irritable bowel syndrome with constipation (IBS-C) in adults.
The three poster presentations will cover:
- Safety and tolerability of tenapanor in pediatric IBS-C patients
- A pharmacokinetic study of tenapanor in breast milk of healthy lactating females
- Correlation between IBS-C symptom severity and financial burden from the IBS in America 2024 survey
Additionally, Ardelyx will sponsor a Product Theater on May 4, featuring Dr. Satish Rao and Christina Hanson, NP, discussing clinical considerations for managing adult IBS-C patients, including efficacy and safety data from Phase 3 trials.
Ardelyx (Nasdaq: ARDX) ha annunciato l'accettazione di tre abstract per presentazioni poster alla Digestive Disease Week Conference (DDW) che si terrà a San Diego dal 3 al 6 maggio 2025. Le presentazioni mostreranno dati su IBSRELA® (tenapanor), il loro trattamento approvato dalla FDA per la sindrome dell'intestino irritabile con stitichezza (IBS-C) negli adulti.
I tre poster riguarderanno:
- Sicurezza e tollerabilità del tenapanor nei pazienti pediatrici con IBS-C
- Uno studio farmacocinetico del tenapanor nel latte materno di donne sane in allattamento
- Correlazione tra la gravità dei sintomi di IBS-C e l'onere finanziario, secondo il sondaggio IBS in America 2024
Inoltre, Ardelyx sponsorizzerà un Product Theater il 4 maggio, con la partecipazione del dott. Satish Rao e di Christina Hanson, NP, che discuteranno le considerazioni cliniche per la gestione degli adulti con IBS-C, inclusi dati di efficacia e sicurezza provenienti dagli studi di Fase 3.
Ardelyx (Nasdaq: ARDX) ha anunciado la aceptación de tres resúmenes para presentaciones en formato póster en la Digestive Disease Week Conference (DDW) en San Diego, del 3 al 6 de mayo de 2025. Las presentaciones mostrarán datos sobre IBSRELA® (tenapanor), su tratamiento aprobado por la FDA para el síndrome del intestino irritable con estreñimiento (IBS-C) en adultos.
Las tres presentaciones en póster cubrirán:
- Seguridad y tolerabilidad de tenapanor en pacientes pediátricos con IBS-C
- Un estudio farmacocinético de tenapanor en la leche materna de mujeres lactantes sanas
- Correlación entre la severidad de los síntomas de IBS-C y la carga financiera según la encuesta IBS en América 2024
Además, Ardelyx patrocinará un Product Theater el 4 de mayo, con la participación del Dr. Satish Rao y Christina Hanson, NP, quienes discutirán consideraciones clínicas para el manejo de pacientes adultos con IBS-C, incluyendo datos de eficacia y seguridad de los ensayos de Fase 3.
Ardelyx (나스닥: ARDX)는 2025년 5월 3일부터 6일까지 샌디에이고에서 열리는 Digestive Disease Week Conference (DDW)에서 포스터 발표를 위한 세 개의 초록이 채택되었다고 발표했습니다. 이번 발표에서는 성인 변비형 과민성 대장증후군(IBS-C) 치료제로 FDA 승인을 받은 IBSRELA®(테나파노르)에 대한 데이터를 선보일 예정입니다.
세 가지 포스터 발표 주제는 다음과 같습니다:
- 소아 IBS-C 환자에서 테나파노르의 안전성과 내약성
- 건강한 수유 여성의 모유 내 테나파노르 약동학 연구
- 2024년 미국 IBS 설문조사에서 IBS-C 증상 심각도와 경제적 부담 간의 상관관계
추가로 Ardelyx는 5월 4일 제품 세미나(Product Theater)를 후원하며, Satish Rao 박사와 간호사 Christina Hanson이 임상적 고려사항과 3상 임상시험의 효능 및 안전성 데이터를 포함한 성인 IBS-C 환자 관리에 대해 논의할 예정입니다.
Ardelyx (Nasdaq : ARDX) a annoncé l'acceptation de trois résumés pour des présentations sous forme de posters lors de la Digestive Disease Week Conference (DDW) à San Diego, du 3 au 6 mai 2025. Ces présentations mettront en avant des données sur IBSRELA® (ténapanor), leur traitement approuvé par la FDA pour le syndrome de l’intestin irritable avec constipation (IBS-C) chez l’adulte.
Les trois posters porteront sur :
- La sécurité et la tolérance du ténapanor chez les patients pédiatriques atteints d’IBS-C
- Une étude pharmacocinétique du ténapanor dans le lait maternel de femmes allaitantes en bonne santé
- La corrélation entre la sévérité des symptômes de l’IBS-C et le fardeau financier selon l’enquête IBS in America 2024
De plus, Ardelyx sponsorisera un Product Theater le 4 mai, avec la participation du Dr Satish Rao et de Christina Hanson, NP, qui discuteront des considérations cliniques pour la prise en charge des patients adultes atteints d’IBS-C, incluant les données d’efficacité et de sécurité issues des essais de phase 3.
Ardelyx (Nasdaq: ARDX) hat die Annahme von drei Abstracts für Posterpräsentationen auf der Digestive Disease Week Conference (DDW) in San Diego vom 3. bis 6. Mai 2025 bekanntgegeben. Die Präsentationen werden Daten zu IBSRELA® (Tenapanor), ihrer von der FDA zugelassenen Behandlung des Reizdarmsyndroms mit Verstopfung (IBS-C) bei Erwachsenen, vorstellen.
Die drei Posterpräsentationen behandeln:
- Sicherheit und Verträglichkeit von Tenapanor bei pädiatrischen IBS-C-Patienten
- Eine pharmakokinetische Studie von Tenapanor in der Muttermilch gesunder stillender Frauen
- Zusammenhang zwischen der Schwere der IBS-C-Symptome und der finanziellen Belastung laut der IBS in America 2024-Umfrage
Zusätzlich wird Ardelyx am 4. Mai ein Product Theater sponsern, bei dem Dr. Satish Rao und Christina Hanson, NP, klinische Überlegungen zur Behandlung erwachsener IBS-C-Patienten besprechen, einschließlich Wirksamkeits- und Sicherheitsdaten aus Phase-3-Studien.
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WALTHAM, Mass., April 24, 2025 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that the company will present data supporting the company’s first-in-class retainagogue, IBSRELA® (tenapanor), as well as results from the IBS in America 2024 supplemental survey, at the upcoming Digestive Disease Week Conference (DDW), to be held May 3-6, 2025, in San Diego. IBSRELA is approved by the U.S. Food and Drug Administration to treat irritable bowel syndrome with constipation (IBS-C) in adults.
Title: Safety and Tolerability of Tenapanor in Pediatric Patients With Irritable Bowel Syndrome With Constipation: An Analysis of Blinded Safety Data from a Phase 3 Study and its Open-Label Extension
Authors: Thomas Wallach, Mihaela Ringheanu, Ana Roig Cantisano, Yang Yang, Karishma Raju, Jocelyn Tabora, Susan Edelstein
Poster Number: Sa1643
Date/Time: May 3, 2025, from 12:30 PM to 1:30 PM PDT
Title: Neither Tenapanor nor its Major Metabolite Were Detected in the Breast Milk of Healthy Lactating Females After 4 Days of Dosing: A Phase 1, Open-Label, Pharmacokinetic Study
Authors: Darren Brenner, Karishma Raju, Kenji Kozuka,Yang Yang, Suling Zhao, Susan Edelstein
Poster Number: Sa1673
Date/Time: May 3, 2025, from 12:30 PM to 1:30 PM PDT
Title: Patient-Reported IBS-C Symptom Severity Correlates Positively With Financial Burden: Results From the IBS in America 2024 Real-World Survey
Authors: Eric Shah, Luisa Scott, Johannah Ruddy, Elizabeth Stremke, Laura Williams, Baharak Moshiree
Poster Number: Mo1257
Date/Time: May 5, 2025, from 12:30 PM to 1:30 PM PDT
In addition to the poster presentations during DDW, Ardelyx is sponsoring a Product Theater titled: “Integrating a Different Mechanism of Action, a different Class of Therapy, Into the Treatment of Adults with IBS-C,” on May 4, 2025, from 12:50-1:35 PM PDT, where Satish Rao, MD, and Christina Hanson, NP, will share important clinical considerations in managing adult patients with IBS-C. The presentation will include interactive patient case studies, along with efficacy and safety data from two Phase 3 clinical trials.
About IBSRELA® (tenapanor)
IBSRELA (tenapanor) is a locally acting inhibitor of the sodium/hydrogen exchanger 3 (NHE3), an antiporter expressed on the apical surface of the small intestine and colon primarily responsible for the absorption of dietary sodium. By inhibiting NHE3 on the apical surface of the enterocytes, tenapanor reduces absorption of sodium from the small intestine and colon, thus retaining luminal water content, which accelerates intestinal transit time and results in a softer stool consistency. IBSRELA has also been shown to reduce abdominal pain by decreasing visceral hypersensitivity and by decreasing intestinal permeability in animal models. In a rat model of colonic hypersensitivity, tenapanor reduced visceral hyperalgesia and normalized colonic sensory neuronal excitability.
About Irritable Bowel Syndrome with Constipation (IBS-C)
Irritable bowel syndrome with constipation (IBS-C) is a gastrointestinal disorder characterized by both abdominal pain and altered bowel movements, estimated to affect 12 million people in the U.S. IBS-C is associated with significantly impaired quality of life, reduced productivity, and substantial economic burden.
IMPORTANT SAFETY INFORMATION
| WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS IBSRELA is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile rats administration of tenapanor caused deaths presumed to be due to dehydration. Avoid use of IBSRELA in patients 6 years to less than 12 years of age. The safety and effectiveness of IBSRELA have not been established in patients less than 18 years of age. |
CONTRAINDICATIONS
IBSRELA is contraindicated in:
- patients less than 6 years of age due to the risk of serious dehydration
- patients with known or suspected mechanical gastrointestinal obstruction
WARNINGS AND PRECAUTIONS
Risk of Serious Dehydration in Pediatric Patients
- IBSRELA is contraindicated in patients below 6 years of age. The safety and effectiveness of IBSRELA in patients less than 18 years of age have not been established. In young juvenile rats (less than 1 week old; approximate human age equivalent of less than 2 years of age), decreased body weight and deaths occurred, presumed to be due to dehydration, following oral administration of tenapanor. There are no data available in older juvenile rats (human age equivalent 2 years to less than 12 years).
- Avoid the use of IBSRELA in patients 6 years to less than 12 years of age. Although there are no data in older juvenile rats, given the deaths in younger rats and the lack of clinical safety and efficacy data in pediatric patients, avoid the use of IBSRELA in patients 6 years to less than 12 years of age.
Diarrhea
Diarrhea was the most common adverse reaction in two randomized, double-blind, placebo-controlled trials of IBS-C. Severe diarrhea was reported in
MOST COMMON ADVERSE REACTIONS
The most common adverse reactions in IBSRELA-treated patients (incidence ≥
INDICATION
IBSRELA (tenapanor) is indicated for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adults. Please see full Prescribing Information, including Boxed Warning, for additional risk information.
About Ardelyx
Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. For more information, please visit https://ardelyx.com/ and connect with us on X (formerly known as Twitter), LinkedIn and Facebook.
Investor and Media Contacts:
Lindsey Manuel
lmanuel@ardelyx.com
FAQ
What are the key findings being presented about IBSRELA (ARDX) at DDW 2025?
When and where will Ardelyx (ARDX) present their DDW 2025 research?
What is the focus of Ardelyx's Product Theater presentation at DDW 2025?
How is Ardelyx (ARDX) expanding IBSRELA's research into new patient populations?
What real-world evidence is Ardelyx presenting about IBS-C treatment costs?
