4-Week, Multi-Center, Randomized, Db-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety & Efficacy of Tenapanor for the T/t of IBS-C in Pts. 6 to < 12 Yrs. Old

This is a randomized, double-blind, placebo-controlled dose-ranging study to assess the safety and efficacy of tenapanor for treatment of the IBS-C in pediatric patients 6 to less than 12 year old.

Start Date24 Jul 2024

Sponsor / Collaborator

Ardelyx, Inc.

NCT06481150 / RecruitingPhase 4IIT

A Novel Approach for Reducing Hyperoxaluria and Kidney Stone Risk.

This pilot study is proposing a novel approach to directly target intestinal oxalate absorption with the drug Tenapanor, which was recently FDA-approved for treating hyperphosphatemia in patients with chronic kidney disease. Tenapanor works by blocking paracellular phosphate absorption by the intestine, but the underlying mechanisms have not been clearly defined. Since phosphate and oxalate ions are absorbed through the same paracellular pathway, and are of similar size and charge, Tenapanor is hypothesized to also reduce dietary oxalate absorption and consequently lower urinary oxalate excretion.

Start Date01 Jul 2024

Sponsor / Collaborator

The University of Texas Southwestern Medical Center

[+1]

100 Clinical Results associated with Tenapanor Hydrochloride

100 Translational Medicine associated with Tenapanor Hydrochloride

100 Patents (Medical) associated with Tenapanor Hydrochloride

108

Literatures (Medical) associated with Tenapanor Hydrochloride

31 Dec 2024·Renal Failure

Efficacy and safety of tenapanor in end-stage renal disease patients with hyperphosphatemia: a systematic review and meta-analysis

Review

Author: Yu, Shanshen ; Sun, Jia ; Guo, Xiafei

BACKGROUNDHyperphosphatemia occurs universally in end-stage renal disease(ESRD), and the attainment of target serum phosphate levels remains suboptimal with currently available phosphate binders. This meta-analysis aimed to evaluate the efficacy and safety of tenapanor in end-stage renal disease patients with hyperphosphatemia.METHODSData sources included PubMed, Embase, Web of Science, and Cochrane Library. This meta-analysis included randomized controlled trials evaluating both the efficacy of tenapanor in reducing serum phosphate levels and its safety profile. The risk of bias was assessed using the Cochrane risk of bias tool for RCTs. The GRADE system was used to assess the overall certainty of evidence. A meta-analysis was carried out by using fixed effects (I² values < 50%) or random effects (I² values ≥ 50%) models to calculate MD with 95% CI for continuous outcome variables and RR with 95% CI for dichotomous variables. Publication bias was evaluated using funnel plots.RESULTSA total of seven RCTs involving 877 individuals were included. The pooling analysis demonstrates that the reduction in mean serum phosphorus levels in the tenapanor group was significantly greater than that in the placebo group [MD= -1.06 mg/dl, 95% CI (-1.59, -0.53); I² = 83%, p < 0.0001]. The proportion of patients achieving a serum phosphorus level of < 5.5 mg/dL, along with the incidence of any adverse events (AEs) and gastrointestinal disorders, was higher in the tenapanor group compared to the placebo group.CONCLUSIONTenapanor has the potential to significantly reduce serum phosphorus levels and enhance the rate of achieving target levels compared to placebo, all while maintaining an acceptable safety and tolerability profile.REGISTRATIONPROSPERO registration number CRD42024544531.

02 Aug 2024·Current Medical Research and Opinion

Effectiveness of tenapanor for treating hyperphosphatemia in patients receiving dialysis: a plain language summary of the OPTIMIZE study

Article

Author: Thomas, Cher ; Weiner, Daniel E ; Edelstein, Susan ; Spiegel, David M ; Rosenbaum, David P ; Sprague, Stuart M

A review.This summary provides a review of the OPTIMIZE study, the results of which were published in Kidney360 in Feb. 2024.The OPTIMIZE study looked at how well tenapanor tablets work to treat patients receiving who have high levels of in their blood, a condition called hyperphosphatemia.In the OPTIMIZE study, researchers wanted to understand if tenapanor would decrease phosphate levels in the blood to the target range.They also tested different ways of starting tenapanor treatment in patients.In the human body, kidneys are organs that filter blood and remove waste products.In chronic kidney disease, sometimes referred to as CKD, a patient kidneys do not work as well at filtering their blood and removing waste products.This can allow phosphate to build up in the blood.Phosphate levels may remain high despite patients receiving treatment such as dialysis, using pills that keep phosphate in the intestines (called ) to prevent phosphate from being absorbed into the blood, and eating a low-phosphate diet.Phosphate levels may remain high despite these treatments because they can be difficult to follow.Most people receiving dialysis take 7-8 phosphate binder pills every day, and over half of those people have reported skipping at least one dose in the past month.Addnl., low-phosphate diets can be difficult to follow and people often struggle to meet their other nutritional needs.Tenapanor used in combination with phosphate binders led to lower phosphate levels in the blood with the use of fewer phosphate-lowering pills.Tenapanor also lowered phosphate levels in patients who were not previously on phosphate binders but needed phosphate-lowering treatment.Tenapanor can help patients receiving dialysis better control their hyperphosphatemia.This is an abstract of the Plain Language Summary of Publication article.View the full Plain Language Summary PDF of this article to read the full-textLink to original article here.

02 Aug 2024·Current Medical Research and Opinion

Tenapanor improves long-term control of high phosphate concentrations in the blood in patients receiving maintenance dialysis: a plain language summary of the NORMALIZE study

Article

Author: Edelstein, Susan ; Battelli, Lori ; Chertow, Glenn M ; Silva, Arnold ; Yang, Yang ; Rosenbaum, David

This is a summary of an article that was published in the medical journal Kidney360 describing results from the NORMALIZE study.The NORMALIZE study looked at how well tenapanor tablets reduced higher-than-normal levels of in the blood of persons with kidney disease who are on .These persons are unable to keep their blood phosphate levels in a normal range, and high levels of phosphate can contribute to several serious health consequences.Tenapanor is approved as an for high levels of phosphate in the blood of adults with chronic kidney disease who are on maintenance dialysis and whose disease does not respond adequately to treatment with or who are not able to take phosphate binders.In earlier clin. studies, tenapanor was studied alone or studied together with phosphate binders.In a 1-yr clin. study called PHREEDOM, researchers learned that when tenapanor was used alone, it lowered blood phosphate levels, and treated patients experienced acceptable safety and tolerability as determined by the doctors running the study.In the NORMALIZE study, adult patients took a 30-mg tenapanor tablet twice a day, either alone or with sevelamer, for up to 18 mo after they completed the PHREEDOM study.The researchers found that one-third of patients taking tenapanor, either alone or with sevelamer, achieved normal blood phosphate levels.This is an improvement from the current standard of care with sevelamer alone to reduce blood phosphate levels.As seen in the earlier studies of tenapanor, the most common experienced by patients was softer or loose stools.No new safety concerns were reported in the NORMALIZE study.The researchers concluded that tenapanor, used alone or combined with sevelamer, can be used long-term by adult patients receiving maintenance dialysis to reduce the phosphate levels in their blood to within the normal range.Patients who take tenapanor may experience softer or loose stools.This summary was developed by the authors to help adult patients with chronic kidney disease receiving dialysis, and their family members and/or caregivers, better understand the effects of taking tenapanor.

140

News (Medical) associated with Tenapanor Hydrochloride

31 Oct 2024

·www.globenewswire.com

Ardelyx Reports Third Quarter 2024 Financial Results and Provides Business Update

IBSRELA generates $40.6 million in net product sales revenue; Company expects full year 2024 IBSRELA net sales revenue to be between $145 and $150 million XPHOZAH generates $51.5 million in net product sales revenue Company ends Q3 with approximately $190 million in cash, cash equivalents and investments Conference call scheduled for 4:30 PM Eastern Time WALTHAM, Mass., Oct. 31, 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 reported financial results for the third quarter ended September 30, 2024 and provided a business update. “The continued strong performance of Ardelyx reported during the third quarter demonstrates our ability to execute and deliver on our goals, to focus on serving the patient and to build towards the future,” said Mike Raab, president and chief executive officer of Ardelyx. “IBSRELA continues to deliver consistent quarter-over-quarter growth driven by strong fundamentals: an attractive safety and efficacy profile, expanding awareness among healthcare prescribers, a streamlined path to access and, importantly, positive experiences among treated patients. In addition, the unmet need among dialysis patients for another option to help achieve and maintain target phosphorus levels is clear, demonstrated by the continued strong demand and growth for XPHOZAH. We remain committed to ensuring that this well-tolerated, effective and differentiated medicine remains available to patients, despite CMS’ planned change in Medicare Part D reimbursement in early-January 2025, and we are confident that we have made decisions that will best support our efforts to protect patient access to XPHOZAH. Finally, we continue to thoughtfully strengthen our balance sheet, providing us with capital to invest as we look to expand our business.” IBSRELA® (tenapanor) records $40.6 million in net product sales revenue in Q3 2024U.S. net product sales revenue for IBSRELA during the third quarter of 2024 was $40.6 million, showing approximately 15% quarter-over-quarter growth compared to the second quarter of 2024, and significant growth compared to the $22.3 million in net product sales revenue the company reported during the third quarter of 2023. The strong Q3 2024 performance reflects the continued growing demand for IBSRELA, demonstrated by increases in new and refill prescriptions as well as growth in new and repeat writing healthcare providers. Ardelyx currently expects full-year 2024 U.S. net product sales revenue for IBSRELA to be between $145.0 and $150.0 million. XPHOZAH® (tenapanor) launch progresses, records $51.5 million net product sales revenue during Q3 2024A strong XPHOZAH launch continues, with the company reporting $51.5 million in net product sales revenue during the third quarter of 2024, approximately 39% quarter-over-quarter growth compared to the second quarter of 2024. The Q3 2024 performance reinforces the significant unmet need among dialysis patients with hyperphosphatemia. Other Corporate Developments Today, the company announced that it amended its February 2022 loan agreement with investment affiliates managed by SLR Capital Partners (SLR). The company drew $50 million at SOFR plus 4.02% in October 2024, added the opportunity to draw an additional $50 million at the same interest rate, and extended the interest-only period for existing and new tranches funded under the instrument to July 1, 2028.The company had a significant presence at the 2024 Annual Scientific Meeting for the American College of Gastroenterology (ACG 2024) in Philadelphia from October 25-30, 2024. The company presented two posters featuring data from the 2024 IBS in America supplemental survey, sponsored by the company in collaboration with Health Union, which was conducted to better understand the symptoms and impact of IBS-C on the overall health and quality of life among patients.The company had a significant presence at the 2024 Annual American Society of Nephrology Kidney Week in San Diego from October 23-27, 2024. The company presented two posters covering additional data for XPHOZAH.In October, the company announced the publication of a review article exploring the patient burden and therapeutic landscape of IBS-C in the U.S. in Clinical and Experimental Gastroenterology. The article is available online and can be found here.In August, the company announced the appointment of experienced biopharma executive, Eric Foster, as Chief Commercial Officer.In July, the company announced the publication of two plain language summaries from XPHOZAH clinical trials in Current Medical Research and Opinion. Third Quarter 2024 Financial Results Cash Position: As of September 30, 2024, the company had total cash, cash equivalents and short-term investments of $190.4 million, as compared to total cash, cash equivalents and short-term investments of $184.3 million as of December 31, 2023. In October, the company drew $49.7 million in net proceeds under its term loan with SLR Investment Corp.Revenue: Total revenue for the quarter ended September 30, 2024 was $98.2 million, compared to $56.4 million in total revenue during the quarter ended September 30, 2023, driven by increases in net product sales. IBSRELA U.S. net product sales revenue was $40.6 million, compared to $22.3 million during the same period of 2023.XPHOZAH U.S. net product sales revenue was $51.5 million, with no comparable revenue during the same period of 2023.Product supply revenue was $5.3 million, compared to $2.1 million during the same period of 2023.Licensing revenue was $20 thousand, compared to $32 million during the same period of 2023 related to $30 million milestone and license agreement amendment payments from Kyowa Kirin following the approval of tenapanor for hyperphosphatemia in Japan, as well as a $2.0 million milestone payment from Fosun Pharma following the acceptance of the NDA for tenapanor for hyperphosphatemia in China.Non-cash royalty revenue related to the sale of future royalties was $0.8 million, with no comparable revenue during the same period of 2023. R&D Expenses: Research and development expenses were $15.3 million for the quarter ended September 30, 2024, compared to $8.6 million for the quarter ended September 30, 2023, primarily related to increased medical engagement with the scientific communities in the areas of gastroenterology and nephrology and pediatric clinical trials.SG&A Expenses: Selling, general and administrative expenses were $65.0 million for the quarter ended September 30, 2024, an increase of $32.3 million compared to $32.7 million for the quarter ended September 30, 2023. The increase in selling, general and administrative expenses was related to increased costs associated with the ongoing commercialization of IBSRELA and XPHOZAH, primarily the expansion of the IBSRELA field-based team which was completed during the third quarter of 2024.Net Loss: Net loss for the quarter ended September 30, 2024 was $0.8 million, or $(0.00) per share, compared to net income of $6.6 million, or $0.03 per share, for the quarter ended September 30, 2023. The $0.8 million net loss for the third quarter of 2024 included share-based compensation expense of $9.1 million and non-cash interest expense related to the sale of future royalties of $1.9 million. Conference Call DetailsThe company will host a conference call today, October 31, 2024, at 4:30 PM ET to discuss today’s announcement. To participate in the conference call, please dial (877) 346-6112 (domestic) or (848) 280-6350 (international) and ask to be joined into the Ardelyx call. A webcast of the call can also be accessed by visiting the Investor page of the company's website, https://ir.ardelyx.com/ and will be available on the website for 30 days following the call. IMPORTANT SAFETY INFORMATION (IBSRELA) 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.IBSRELA is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. WARNINGS AND PRECAUTIONSRisk 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 2.5% of IBSRELA-treated patients. If severe diarrhea occurs, suspend dosing and rehydrate patient. MOST COMMON ADVERSE REACTIONS The most common adverse reactions in IBSRELA-treated patients (incidence ≥2% and greater than placebo) were: diarrhea (16% vs 4% placebo), abdominal distension (3% vs <1%), flatulence (3% vs 1%) and dizziness (2% vs <1%). 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. IMPORTANT SAFETY INFORMATION (XPHOZAH) 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. Forward Looking StatementsTo the extent that statements contained in this press release are not descriptions of historical facts regarding Ardelyx, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including Ardelyx’s current expectation regarding opportunities for continued IBSRELA and XPHOZAH adoption; projected U.S. net product sales revenue for IBSRELA for full year 2024; the company’s ability to execute and deliver on its goals and expand its business; and the company’s ability to protect patient access to XPHOZAH. Such forward-looking statements involve substantial risks and uncertainties that could cause Ardelyx's future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties associated with the development of, regulatory process for, and commercialization of drugs in the U.S. and internationally. Ardelyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ardelyx's business in general, please refer to Ardelyx's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on October 31, 2024, and its future current and periodic reports to be filed with the Securities and Exchange Commission. Investor and Media Contacts: Caitlin Lowieclowie@ardelyx.com Ardelyx, Inc.Condensed Balance Sheets(In thousands) September 30, 2024 December 31, 2023 (Unaudited) (1) Assets Cash and cash equivalents$47,429 $21,470 Investments 142,973 162,829 Accounts receivable 53,195 22,031 Prepaid commercial manufacturing 16,663 18,925 Prepaid commercial manufacturing, non-current — 4,235 Inventory, current 11,378 12,448 Inventory, non-current 73,780 37,039 Property and equipment, net 1,028 1,009 Right-of-use assets 3,625 5,589 Prepaid and other assets 17,792 12,004 Total assets$367,863 $297,579 Liabilities and stockholders' equity Accounts payable$15,824 $11,138 Accrued compensation and benefits 11,541 12,597 Current portion of operating lease liability 2,567 4,435 Deferred revenue 20,042 15,826 Accrued expenses and other liabilities 33,295 15,041 Operating lease liability, net of current portion 1,218 1,725 Long-term debt 100,707 49,822 Deferred royalty obligation related to the sale of future royalties 24,372 20,179 Stockholders' equity 158,297 166,816 Total liabilities and stockholders' equity$367,863 $297,579 (1) Derived from the audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. Ardelyx, Inc.Condensed Statements of Operations(Unaudited)(In thousands, except share and per share amounts) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Revenues: Product sales, net: IBSRELA$40,638 $22,285 $104,444 $51,949 XPHOZAH 51,452 — 103,749 — Total product sales, net 92,090 22,285 208,193 51,949 Product supply revenue 5,322 2,092 7,461 5,354 Licensing revenue 20 32,014 56 32,790 Non-cash royalty revenue related to the sale of future royalties 809 — 1,776 — Total revenues 98,241 56,391 217,486 90,093 Cost of goods sold: Cost of product sales 1,715 644 4,133 1,508 Other cost of revenue 14,013 7,048 28,159 11,210 Total cost of goods sold 15,728 7,692 32,292 12,718 Operating expenses: Research and development 15,310 8,637 38,651 26,012 Selling, general and administrative 64,970 32,664 182,618 86,653 Total operating expenses 80,280 41,301 221,269 112,665 Income (loss) from operations 2,233 7,398 (36,075) (35,290)Interest expense (3,357) (1,107) (9,039) (3,210)Non-cash interest expense related to the sale of future royalties (1,924) (922) (5,202) (2,859)Other income, net 2,282 1,460 6,766 4,308 Income (loss) before provision for income taxes (766) 6,829 (43,550) (37,051)Provision for income taxes 43 200 231 214 Net income (loss)$(809) $6,629 $(43,781) $(37,265)Net income (loss) per share of common stock - basic and diluted$(0.00) $0.03 $(0.19) $(0.17)Shares used in computing net income (loss) per share - basic 235,911,399 222,782,229 234,516,305 214,976,555 Shares used in computing net (loss) income per share - diluted 235,911,399 227,894,335 234,516,305 214,976,555

License out/inFinancial StatementDrug ApprovalExecutive Change

28 Oct 2024

·www.globenewswire.com

Ardelyx Presents Results from its IBS in America 2024 Supplemental Survey at the American College of Gastroenterology’s (ACG) Annual Meeting

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

Clinical ResultDrug Approval

24 Oct 2024

·www.globenewswire.com

Ardelyx Shares Additional Data Supporting First-In-Class XPHOZAH® (tenapanor) at the American Society of Nephrology’s Kidney Week

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

Clinical ResultPhase 3Drug ApprovalLicense out/in

100 Deals associated with Tenapanor Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D11653	Tenapanor Hydrochloride	A06AX	DB11761

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hyperphosphatemia	JP	Kyowa Kirin Co., Ltd.	25 Sep 2023
Irritable bowel syndrome with constipation	US	Ardelyx, Inc.	12 Sep 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hyperphosphatemia	NDA/BLA	CN	Ardelyx, Inc.	12 Jul 2023
Hyperphosphatemia	NDA/BLA	CN	Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.	12 Jul 2023
Parkinson Disease	Phase 2	-	Ardelyx, Inc.	01 Dec 2024
Kidney Failure, Chronic	Phase 1	US	Ardelyx, Inc.	01 Jan 2016
Albuminuria	Phase 1	US	Ardelyx, Inc.	01 May 2013
Albuminuria	Phase 1	US	AstraZeneca PLC	01 May 2013
Diabetes Mellitus, Type 2	Phase 1	US	Ardelyx, Inc.	01 May 2013
Diabetes Mellitus, Type 2	Phase 1	US	AstraZeneca PLC	01 May 2013
Chronic kidney disease, Stage V	Phase 1	US	AstraZeneca PLC	01 Jan 2013
Chronic kidney disease, Stage V	Phase 1	US	Ardelyx, Inc.	01 Jan 2013

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


DDW2024	Not Applicable	Irritable bowel syndrome with constipation	-	Tenapanor 50 mg	smohkayvrn(ncpffugqol) = vgehzitxsl kghpzarxha (dikjftadca )	-	21 May 2024
				Placebo	smohkayvrn(ncpffugqol) = milmiabqzb kghpzarxha (dikjftadca )
ISN WCN2024	Not Applicable	Kidney Failure, Chronic	944	Tenapanor	cksjtzovpz(bfnkyjscap) = Tenapanor significantly increased the incidence of diarrhea relative to placebo yhfzorsbem (ocjczbsqad ) View more	Positive	01 Apr 2024
NCT04549597 (OPTIMIZE, Pubmed) Manual	Phase 4	Hyperphosphatemia Maintenance	333	switch from PBs to tenapanor (Straight Switch)	(ygrkqfgdxv) = njhclrszrx eaupatenep (vqwzvotelx ) View more	Positive	07 Feb 2024
				reduce PB dosage by ≥50% and add tenapanor (Binder Reduction)	(ygrkqfgdxv) = nisscordkv eaupatenep (vqwzvotelx ) View more
NCT03988920 (NORMALIZE, Pubmed \| Kidney360)	Phase 3	Hyperphosphatemia Maintenance serum intact fibroblast growth factor-23 \| serum intact parathyroid hormone	172	Tenapanor 30 mg twice daily	rlamzxqpai(rxymymmvfs) = The most commonly reported treatment-emergent adverse event was diarrhea in 38 of 172 patients (22%), which led to tenapanor discontinuation in four patients (2%) esbwykpzsn (clrmfobjli )	Positive	01 Nov 2023
NCT02675998 \| NCT03427125 \| NCT03824587 (TEN-02-202 , FDA) Manual	Phase 2/3	Hyperphosphatemia	964	XPHOZAH (TEN-02-301)	(pyitwtletv) = lpohmbnaso nsiwyhcyma (mpfcozlvxa, 0.2 - 1.1)	Positive	17 Oct 2023
				placebo (TEN-02-301)	-
NCT03427125 (PHREEDOM \| TEN-02-301, CTgov)	Phase 3	Hyperphosphatemia \| Kidney Failure, Chronic	1,559	Tenapanor (Tenapanor 10 mg, 20 mg, 30 mg BID)	owgctkrvfs(jcsfqowfee) = fsmfzawzhd ifqnxapbev (sjhckorphj, omjosfbxir - yjjchfrmcd) View more	-	29 Jun 2023
				Placebo (Placebo)	owgctkrvfs(jcsfqowfee) = qaqdadnipn ifqnxapbev (sjhckorphj, qgkoqxhssn - peybatvxol) View more
DDW2023	Not Applicable	Irritable bowel syndrome with constipation	-	Tenapanor 50 mg bid	(hzhparesnr) = rfeuqbdduv ehlgsldwlw (fsvutbjmvy )	-	09 May 2023
DDW2023	Not Applicable	Irritable bowel syndrome with constipation	-	Tenapanor 50 mg bid	(rgwxrpfikg) = sbuvechvef smpcwxgtim (cnpsfrmliy )	-	09 May 2023
NCT03988920 (NORMALIZE, CTgov)	Phase 4	Hyperphosphatemia \| Kidney Failure, Chronic	172	Sevelamer Carbonate+Tenapanor (Tenapanor w/Sevelamer)	dhxznrgjbp(xcknkpwyvl) = amznhphtqb jwstmqtith (hjqkveoqtx, tlvrhjzpap - bynxbnpkjb) View more	-	29 Mar 2023
				Sevelamer Carbonate+Tenapanor (Sevelamer w/Tenapanor)	dhxznrgjbp(xcknkpwyvl) = rdzjcgveek jwstmqtith (hjqkveoqtx, quiqdydnfs - awabmxrjpe) View more
NCT04549597 (OPTIMIZE, CTgov)	Phase 4	Hyperphosphatemia \| Chronic Kidney Diseases	333	Tenapanor (Cohort 1: Straight Switch)	xehwwnpapo(pjcrkgxncn) = kzghpyktiu utcqbukpho (boltkzxpbc, lkykpyvhjo - ifhjjuxsgm) View more	-	29 Mar 2023
				Tenapanor (Cohort 2: Decrease Phosphate Binder by 50%)	xehwwnpapo(pjcrkgxncn) = copwsiqjvx utcqbukpho (boltkzxpbc, chxlwbwynf - meuxqznctn) View more

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