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Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical firm based with a mission to find, develop and commercialize modern, first-in-class medicines that meet vital unmet medical wants, as we speak introduced that the corporate introduced knowledge, together with outcomes from the primary real-world examine of XPHOZAH, at American Society of Nephrology’s Kidney Week, at the moment underway in Houston.
XPHOZAH is the primary and solely phosphate absorption inhibitor (PAI) accepted by the U.S. Meals and Drug Administration to cut back serum phosphorus in adults with power kidney illness on dialysis as add-on remedy in sufferers who’ve an insufficient response to phosphate binders or who’re illiberal of any dose of phosphate binder remedy. XPHOZAH gives a unique mechanism of motion that blocks phosphate absorption on the main pathway and is run as a single pill taken twice each day.
“We’re excited to current new knowledge on XPHOZAH at ASN’s Kidney Week, together with the primary outcomes from our potential, observational cohort examine designed to judge the influence of an XPHOZAH-based routine in a real-world setting, in sufferers with hyperphosphatemia on upkeep dialysis who weren’t managed on binder remedy,” mentioned Edward Conner, MD, Chief Medical Officer. “Phosphate administration is essential for sufferers with power kidney illness on dialysis, because the failure to take action results in the next danger of comorbidities, demise, and a possible delay in transplant waitlisting. Our outcomes present the influence XPHOZAH can have in decreasing serum phosphorus ranges for these sufferers, and that its’ effectiveness extends exterior the medical trial setting and into the real-world.”
Poster #TH-PO0221, entitled “Actual-World Effectiveness of Tenapanor (XPHOZAH) for Remedy of Hyperphosphatemia in United States Sufferers on Dialysis,” highlights outcomes from the primary real-world examine of tenapanor for administration of serum phosphate, aimed to characterize real-world use and effectiveness within the U.S. dialysis setting. Sufferers prescribed tenapanor skilled a discount in serum phosphate of practically 1 mg/dL on common. Almost half of individuals (45.3%) skilled ≥1 mg/dL discount in serum phosphorus and 25.1% skilled a discount of ≥2 mg/dL. Outcomes had been related between all initiators and sufferers persisting on tenapanor for all the follow-up interval of 120 days. These findings assist the real-world effectiveness of tenapanor for administration of serum phosphate in sufferers with end-stage kidney illness (ESKD) and hyperphosphatemia.
Poster #TH-PO0224, entitled “Remedy Satisfaction with Tenapanor (XPHOZAH): Actual-World Survey of Sufferers with Finish-Stage Renal Illness and Hyperphosphatemia,” presents constructive affected person experiences with tenapanor in a real-world survey collected by the ArdelyxAssist affected person providers program and related pharmacy knowledge. Excluding respondents who didn’t understand how their phosphate ranges had modified, 63% of sufferers reported their phosphate ranges had been higher since beginning tenapanor. Of the sufferers who reported a change in serum phosphate ranges, 69% indicated that their outlook on serum phosphate management was slightly or significantly better, with 44% attributing the change to raised serum phosphate management, 39% to improved bowel actions, and 14% to decrease capsule burden. These knowledge spotlight the constructive experiences sufferers have with tenapanor in the actual world, together with improved serum phosphate management, bowel actions, and decrease capsule burden, in addition to the necessity for higher affected person schooling.
Poster #FR-PO0254, entitled “Etelcalcetide Utilization Charges Decreased and Parathyroidectomy Charges Elevated Following the Incorporation of Calcimimetics into the Finish-Stage Kidney Illness Bundle,” examines traits in calcimimetic use, together with cinacalcet and etelcalcetide (ETEL), and parathyroidectomy (PTX) charges amongst sufferers on upkeep hemodialysis throughout and after the Transitional Drug Add-On Fee Adjustment (TDAPA) interval, contemplating race and dialysis group (DO) dimension. It was proven that ETEL use elevated throughout the TDAPA interval and decreased sharply when it ended. Conversely, PTX charges declined throughout the TDAPA interval and elevated upon its conclusion when ETEL utilization decreased. Outcomes of this examine spotlight the influence of reimbursement coverage on medical follow and affected person outcomes, underlining the unintended penalties of decreasing entry to efficient therapies, rising well being disparities and doubtlessly suppressing future therapeutic innovation.
Poster #TH-PO0223, entitled “Tenapanor Improves Bowel Actions in Sufferers with Finish-Stage Kidney Illness and Gentle to Extreme Constipation,” is a post-hoc evaluation of the Section 3 BLOCK examine that analyzed the consequences of tenapanor on stool frequency and consistency in sufferers with ESKD who skilled constipation at baseline. Constipation happens in 30%-40% of sufferers with ESKD receiving dialysis. The outcomes of the eight-week examine confirmed improved weekly stool frequency (WSF) and stool consistency. Amongst sufferers with a baseline WSF of ≤ 3, (Extreme Constipation), weekly stool frequency elevated to inside the regular vary and the weekly stool consistency rating improved from constipation to regular. Comparable reductions in serum phosphate had been noticed in each teams studied, Extreme Constipation and Constipation (WSF ≤ 6).
Poster #FR-PO0255, entitled “Value-Effectiveness Evaluation of Tenapanor in Japanese Sufferers with Hyperphosphatemia on Hemodialysis,” introduced by Kyowa Kirin Co., Ltd., Ardelyx’s collaboration companion for tenapanor in Japan, is an evaluation of the cost-effectiveness for tenapanor in hemodialysis sufferers from the Japanese public healthcare payer’s perspective. It was concluded that in each affected person populations analyzed, tenapanor was cost-effective, satisfying the brink of 5 million Japanese Yen for the Japanese willingness to pay.
Poster shows are actually publicly accessible and will be accessed on demand right here .
About XPHOZAH ® (tenapanor)
XPHOZAH, found and developed by Ardelyx, is a first-in-class, phosphate absorption inhibitor with a differentiated mechanism of motion that acts regionally within the intestine to inhibit the sodium hydrogen exchanger 3 (NHE3), thereby decreasing phosphate absorption by the paracellular pathway, the first pathway of phosphate absorption. XPHOZAH is a single pill, taken twice each day. Diarrhea was the commonest facet impact skilled by sufferers taking XPHOZAH in medical trials. Please see further full Prescribing Data .
About Hyperphosphatemia
Hyperphosphatemia is a severe situation, outlined as elevated ranges of phosphate within the blood, which impacts the overwhelming majority of the 550,000 sufferers in the USA with power kidney illness (CKD) on upkeep dialysis. The kidneys are chargeable for eliminating extra phosphate and as kidney perform declines, phosphate just isn’t adequately eradicated from the physique. Consequently, hyperphosphatemia is an almost common situation amongst folks with CKD on upkeep dialysis, with internationally acknowledged KDIGO therapy pointers that suggest decreasing elevated phosphate ranges towards the traditional vary (2.5-4.5mg/dL).
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
XPHOZAH is contraindicated in:
- Pediatric sufferers below 6 years of age
- Sufferers with identified or suspected mechanical gastrointestinal obstruction
WARNINGS AND PRECAUTIONS
Diarrhea
Sufferers might expertise extreme diarrhea. Remedy with XPHOZAH needs to be discontinued in sufferers who develop extreme diarrhea.
MOST COMMON ADVERSE REACTIONS
Diarrhea, which occurred in 43-53% of sufferers, was the one antagonistic response reported in no less than 5% of XPHOZAH-treated sufferers with CKD on dialysis throughout trials. The vast majority of diarrhea occasions within the XPHOZAH-treated sufferers had been reported to be mild-to-moderate in severity and resolved over time, or with dose discount. Diarrhea was sometimes reported quickly after initiation however may happen at any time throughout therapy with XPHOZAH. Extreme diarrhea was reported in 5% of XPHOZAH-treated sufferers in these trials.
INDICATION
XPHOZAH (tenapanor), 30 mg BID, is indicated to cut back serum phosphorus in adults with power kidney illness (CKD) on dialysis as add-on remedy in sufferers who’ve an insufficient response to phosphate binders or who’re illiberal of any dose of phosphate binder remedy.
For extra security data, please see full Prescribing Data .
About Ardelyx
Ardelyx was based with a mission to find, develop and commercialize modern, first-in-class medicines that meet vital unmet medical wants. Ardelyx has two business merchandise accepted in the USA, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor) in addition to early-stage pipeline candidates. The corporate is creating RDX10531, a next-generation NHE3 inhibitor with potential utility throughout a number of therapeutic areas. Ardelyx has agreements for the event and commercialization of tenapanor exterior of the U.S. Kyowa Kirin commercializes PHOZEVEL ® (tenapanor) for hyperphosphatemia in Japan. A New Drug Software for tenapanor for hyperphosphatemia has been accepted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. For extra data, please go to https://ardelyx.com/ and join with us on X (previously often known as Twitter) , LinkedIn and Fb .
Investor and Media Contacts:
Lindsey Manuel
lmanuel@ardelyx.com
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