Knight Therapeutics, Inc.

Ninety percent of survey participants reported “some” or “significant” negative impact of IBS-C on their life Survey results presented in two poster presentations WALTHAM, Mass., Oct. 28, 2024 (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 results from the IBS in America 2024 supplemental survey, in partnership with Health Union, were presented at the American College of Gastroenterology’s (ACG) Annual Scientific Meeting & Postgraduate Course, currently taking place in Philadelphia. Developed as an online, nationwide survey conducted in partnership with Health Union, more than 280 irritable bowel syndrome with constipation (IBS-C) patients were surveyed to better understand their symptoms and the impact of IBS-C on their overall health and quality of life. “Ardelyx is committed to better understanding the lived experience of patients with IBS-C, and the insights gained from our IBS in America supplemental survey clearly outline the everyday impact of IBS-C on patients, which extends far beyond constipation and results in a low quality of life for many patients,” said Johannah Ruddy, M.Ed, director, patient advocacy at Ardelyx. “The supplemental survey provides us with unique insights into what symptoms patients are experiencing, and how often. We hope these findings spark productive conversations between patients and their healthcare providers on how to recognize, understand and treat IBS-C to improve the lives of those living with this condition, and raise awareness of the need for broader dialogue around this condition.” Notably, 90% of IBS-C patients surveyed reported “some” or “significant” negative impact of IBS-C on their life, with a majority indicating they feel a negative impact on their mental and emotional health, sexual health and intimacy, relationships and sense of independence. More than one-third of IBS-C patients described their quality of life as “poor” or “fair,” often attributed to having multiple health conditions. The comorbidities most experienced and reported included mental health conditions, chronic pain conditions, metabolic disorders and other gastrointestinal disorders. A Media Snippet accompanying this announcement is available by clicking on this link. Additional survey findings include: 85% of patients experienced pain in the rectum or anus while trying to have bowel movementsOver 55% of patients reported a feeling of incomplete bowel movement “often” or “always” in the previous seven daysMost of those surveyed experienced other symptoms in addition to constipation, including: 86% of patients experienced bloating85% of patients experienced abdominal cramps and pain64% of patients experienced fatigue Of the 104 respondents currently perimenopausal or having menstrual periods, more than 45% felt that menstruation made constipation worse, and over 80% felt menstruation exacerbated abdominal pain and bloating symptomsOver 45% of patients considered IBS-C “somewhat,” “quite a bit” or “very much” a financial hardship to themselves and their families Data from the IBS in America 2024 supplemental survey was presented in two posters during ACG’s Annual Scientific Meeting this week, which are publicly available here. Title: Irritable Bowel Syndrome With Constipation Poses a Substantial Burden to Patient Overall Health Status and Quality of Life: Results From the IBS In America 2024 Real-World SurveyAuthors: Eric Shah, Johannah Ruddy, Belinda Gist, Elizabeth Stremke, Laura Williams, Baharak MoshireePoster Number: P0641 Title: Patients With Irritable Bowel Syndrome With Constipation From the IBS In America 2024 Real-World Survey Experience Burdensome Symptoms Beyond ConstipationAuthors: Baharak Moshiree, Johannah Ruddy, Belinda Gist, Elizabeth Stremke, Laura Williams, Eric ShahPoster Number: P2335 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. About IBS in America 2024IBS in America 2024 was a 15-minute, real-world, online survey fielded by Health Union from January 15 to April 14, 2024, in United States residents age 18 and older. The survey covered demographics, comorbidities, quality of life impact, treatments and health care provider (HCP) interactions. Patients who completed the survey were invited to participate in an institutional review board–approved supplemental extension survey if they met the following criteria: diagnosed with IBS-C or IBS with alternating diarrhea and constipation by an HCP, currently seeing an HCP to treat IBS, and had ever used an over the counter or prescription treatment for IBS. Four questions addressed patients’ menstrual status and the impact of menstruation on constipation. These analyses only include patients diagnosed with IBS-C who completed the supplemental extension survey. Respondents with IBS-C (N=284) had a mean (range) age of 51 (18-86) years and were predominantly female (92%; 48% postmenopausal) and White (87%). Most respondents had been living with IBS-C for ≥2 years, and 80% of respondents reported IBS episodes occurring weekly or daily over the past year. This survey was designed to learn about patients’ experience with IBS-C and did not investigate safety or efficacy of any prescription drugs for management of IBS-C. About Health UnionHealth Union is the proven industry leader in condition-specific, online health community and patient engagement. The company reaches millions of people through the largest network of online health communities (e.g., Migraine.com, MultipleSclerosis.net, LungCancer.net) and health leaders – addressing virtually every condition and providing patients and caregivers with the information, connection, and support they need to live better with challenging health conditions. For more than a decade, Health Union has been transforming the way pharmaceutical and healthcare brands engage with people, enabling transparent, innovative opportunities to gain insight and empower action through advertising, marketing research, and clinical trial solutions for the healthcare industry. About ArdelyxArdelyx 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 submitted 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: Caitlin Lowieclowie@ardelyx.com

WALTHAM, Mass., Oct. 24, 2024 (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 data supporting additional positive clinical observations of XPHOZAH® (tenapanor) was presented in a series of poster presentations at the American Society of Nephrology’s (ASN) Kidney Week, currently taking place in San Diego. Ardelyx is also hosting an Exhibitor Spotlight discussing hyperphosphatemia management. XPHOZAH, the first and only phosphate absorption inhibitor (PAI), is approved by the U.S. Food and Drug Administration to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. XPHOZAH offers a different mechanism of action that blocks phosphate absorption at the primary pathway and is administered as a single tablet taken twice daily. “We are pleased to be able to continue to expand our understanding of the significant impact XPHOZAH can have to help patients with chronic kidney disease on dialysis with elevated phosphorus,” said David Spiegel, MD, senior vice president, nephrology at Ardelyx. “Patients on dialysis and their healthcare providers have long struggled to achieve and maintain serum phosphate levels within guideline-established levels. The addition of XPHOZAH is an important tool in phosphate management and these data demonstrate the benefit that XPHOZAH’s blocking mechanism can offer patients.” Poster #TH-PO164, entitled “Sustained Phosphate Reduction Assessed by P AUC With Tenapanor Is Associated With Reduced Fibroblast Growth Factor 23 in Patients With Chronic Kidney Disease and Hyperphosphatemia on Dialysis,” is a post-hoc analysis of the PHREEDOM Phase 3 clinical trial, and assessed whether long-term phosphate (P) control measured using average phosphate area under the curve (P AUC) with tenapanor is associated with lower iFGF23. iFGF23 is elevated in patients with chronic kidney disease and is associated with increased cardiovascular mortality. The analysis observed greater percent reductions from baseline in iFGF23 in P AUC categories representative of better P control than categories representative of worse control. Poster #TH-PO169, entitled “Tenapanor Reduces Serum Phosphate With Similar Efficacy and Tolerability Profiles When Added to Various Phosphate Binders,” is a post hoc analysis of data from the AMPLIFY Phase 3 clinical trial and OPTIMIZE open-label clinical trial and examined the efficacy and tolerability of tenapanor when added to different phosphate binders (PBs). The analysis found that tenapanor added to PBs provided a clinically meaningful serum P reduction with similar efficacy and tolerability regardless of the type of PB. Poster presentations are now publicly available and can be accessed on demand here. In addition to the poster presentations during ASN Kidney Week, Ardelyx is sponsoring an Exhibitor Spotlight titled: “A Different Perspective on Hyperphosphatemia Management: Evaluating Current Strategies,” on October 25, 2024, from 11:00 – 11:45 AM PDT, where Steven Fishbane, MD, will discuss first-in-class PAI, XPHOZAH. The presentation will review the XPHOZAH mechanism of action, efficacy and safety data from the Phase 3 clinical trial program and will include a discussion about the clinical application of XPHOZAH as add-on therapy for the many dialysis patients on a phosphate binder with serum phosphorus levels above guideline-established targets. About XPHOZAH® (tenapanor)XPHOZAH, discovered and developed by Ardelyx, is a first-in-class, phosphate absorption inhibitor with a differentiated mechanism of action that acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), thereby reducing phosphate absorption through the paracellular pathway, the primary pathway of phosphate absorption. XPHOZAH is a single tablet, taken twice daily. Diarrhea was the most common side effect experienced by patients taking XPHOZAH in clinical trials. Please see additional full Prescribing Information. About HyperphosphatemiaHyperphosphatemia is a serious condition, defined as elevated levels of phosphate in the blood, which affects the vast majority of the 550,000 patients in the United States with chronic kidney disease (CKD) on maintenance dialysis. The kidneys are responsible for eliminating excess phosphate and as kidney function declines, phosphate is not adequately eliminated from the body. As a result, hyperphosphatemia is a nearly universal condition among people with CKD on maintenance dialysis, with internationally recognized KDIGO treatment guidelines that recommend lowering elevated phosphate levels toward the normal range (2.5-4.5mg/dL). IMPORTANT SAFETY INFORMATION CONTRAINDICATIONSXPHOZAH is contraindicated in: Pediatric patients under 6 years of agePatients with known or suspected mechanical gastrointestinal obstruction WARNINGS AND PRECAUTIONSDiarrhea Patients may experience severe diarrhea. Treatment with XPHOZAH should be discontinued in patients who develop severe diarrhea. MOST COMMON ADVERSE REACTIONS Diarrhea, which occurred in 43-53% of patients, was the only adverse reaction reported in at least 5% of XPHOZAH-treated patients with CKD on dialysis across trials. The majority of diarrhea events in the XPHOZAH-treated patients were reported to be mild-to-moderate in severity and resolved over time, or with dose reduction. Diarrhea was typically reported soon after initiation but could occur at any time during treatment with XPHOZAH. Severe diarrhea was reported in 5% of XPHOZAH-treated patients in these trials. INDICATION XPHOZAH (tenapanor), 30 mg BID, is indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. For additional safety information, please see full Prescribing Information. About ArdelyxArdelyx 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 submitted 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: Caitlin Lowieclowie@ardelyx.com

WALTHAM, Mass., Oct. 22, 2024 (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 the launch of Gut Matters: Discoveries and Innovations, a new podcast for the irritable bowel syndrome with constipation (IBS-C) patient community. The podcast is hosted by Ardelyx’s director, patient advocacy, Johannah Ruddy, M.Ed. and practicing gastroenterologist, Andrea Shin, MD. The first episode is out now. Each month, the hosts will be joined by patients, caregivers, advocacy leaders, healthcare providers and other gastroenterology experts to discuss the impact of IBS-C and provide education and hope for those affected. “People living with IBS-C often feel lonely and stigmatized. We wanted to create a safe space where people with this condition can find fact-based information, hear stories that likely sound like their own, and gain valuable insights that will provide them with hope as well as the tools to better manage their condition,” said Andrea Shin, MD and podcast co-host. “I am really proud to be a part of the Gut Matters: Discoveries and Innovations podcast. Our hope is to empower patients, family members and caregivers by showing them that they are part of a large community.” Individuals can subscribe to the podcast and keep up on the latest episodes here, or wherever they get their podcasts. 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. About ArdelyxArdelyx 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 submitted 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: Caitlin Lowieclowie@ardelyx.com