A randomized controlled non-blinded trial for examination of effectiveness of Upacicalcet and Etelcalcetide on hyperparathyroidism in hemodialysis patients. - A randomized controlled non-blinded trial for examination of effectiveness of Upacicalcet and Etelcalcetide on hyperparathyroidism in hemodialysis patients.

Start Date15 Jan 2024

Sponsor / Collaborator-

NCT05836220 / Active, not recruitingPhase 3

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Dose-Titrated PLS240 in the Treatment of Secondary Hyperparathyroidism in Individuals With End Stage Kidney Disease on Hemodialysis (PATH-2) With an Open-Label Extension

This study is to evaluate the efficacy and safety of PLS240 in patients with hemodialysis-dependent end stage kidney disease (ESKD) and secondary hyperparathyroidism (SHPT). The study consists of two phases. First, a placebo-controlled, double-blind phase where patients will be randomly assigned to either receive dose-titrated PLS240 or matching placebo for 27 weeks. After the completion of the double-blind phase, patients will be eligible to enroll in the open-label extension phase, where they will receive dose-titrated PLS240 for an additional 26 weeks. Throughout the duration of the study, patients will be expected to attend multiple study visits where an investigator will collect blood, preform electrocardiograms (ECGs) and physical exams, and further assess the safety and efficacy of PLS240.

Start Date15 May 2023

Sponsor / Collaborator

Pathalys Pharma, Inc.Startup

[+1]

NCT05832931 / Active, not recruitingPhase 3

Start Date28 Apr 2023

Sponsor / Collaborator

Pathalys Pharma, Inc.Startup

[+1]

100 Clinical Results associated with Upacicalcet Sodium Hydrate

100 Translational Medicine associated with Upacicalcet Sodium Hydrate

100 Patents (Medical) associated with Upacicalcet Sodium Hydrate

Literatures (Medical) associated with Upacicalcet Sodium Hydrate

01 Aug 2024·Therapeutic Apheresis and Dialysis

Calcimimetics treatment strategy for serum calcium and phosphate management in patients with secondary hyperparathyroidism undergoing dialysis: A systematic review and meta‐analysis of randomized studies

Review

Author: Fukagawa, Masafumi ; Yamada, Shunsuke ; Hamano, Takayuki ; Nakai, Kentaro ; Kono, Keiji ; Taniguchi, Masatomo

AbstractIntroductionSeveral calcimimetics, other than cinacalcet, are commercially available; however, their effects on calcium and phosphate levels have not yet been fully studied. We conducted a systematic review and meta‐analysis of randomized controlled trials to evaluate the impact of calcimimetics on the management of serum calcium and phosphate levels in patients with secondary hyperparathyroidism undergoing dialysis.MethodsA systematic literature search through October 2023 and a meta‐analysis were conducted on the effects of upacicalcet, etelcalcetide, evocalcet, and cinacalcet on serum calcium and phosphate levels in patients with secondary hyperparathyroidism undergoing dialysis; we searched PubMed, Ovid MEDLINE, and the Cochrane Central Register of Controlled Trials, and 21 studies comprising 6371 patients undergoing dialysis were included.ResultsParticipants treated with calcimimetics had lower serum calcium and phosphate levels than placebo.ConclusionCalcimimetics significantly reduced serum calcium and phosphate levels compared to placebo in patients with secondary hyperparathyroidism undergoing dialysis, independent of therapeutic strategy or concomitant vitamin D treatment.

01 Jan 2024·BMJ Open

Multicentre, open-label, randomised, controlled trial to compare early intervention with calcimimetics and conventional therapy in preventing coronary artery calcification in patients with secondary hyperparathyroidism (UPCOMING): a study protocol

Article

Author: Tsuboi, Naotake ; Ogata, Soshiro ; Tatematsu, Yoshitaka ; Watanabe, Eiichi ; Okamoto, Naoki ; Kawai, Hideki ; Yuzawa, Yukio ; Inaguma, Daijo ; Hasegawa, Midori

IntroductionCoronary artery and heart valve calcification is a risk factor for cardiovascular death in haemodialysis patients, so calcification prevention should be started as early as possible. Treatment with concomitant calcimimetics and low-dose vitamin D receptor activators (VDRAs) is available, but not enough evidence has been obtained on the efficacy of this regimen, particularly in patients with short dialysis duration. Therefore, this study will evaluate the efficacy and safety of early intervention with upacicalcet, a calcimimetic used to prevent coronary artery calcification in this patient population.Methods and analysisThis multicentre, open-label, randomised, parallel-group controlled study will compare an early intervention group, which received upacicalcet and a low-dose VDRA, with a conventional therapy group, which received a VDRA. The primary endpoint is a change in log coronary artery calcium volume score from baseline to 52 weeks. The main inclusion criteria are as follows: (1) age 18 years or older; (2) dialysis is planned or dialysis duration is less than 60 months; (3) intact parathyroid hormone (PTH) >240 pg/mL or whole PTH level>140 pg/mL; (4) serum-corrected calcium≥8.4 mg/dL and (5) Agatston score >30. The main exclusion criteria are as follows: (1) history of parathyroid intervention or fracture in the past 12 weeks; (2) history of myocardial infarction, stroke or leg amputation in the past 12 weeks; (3) history of coronary angioplasty and (4) heart failure of New York Heart Association class III or worse.Ethics and disseminationThe study will comply with the Declaration of Helsinki and the Japanese Clinical Trials Act. The study protocol has been approved by the Fujita Health University Certified Review Board (file no. CR22-052). Written informed consent will be obtained from all participants. Study results will be presented in academic meetings and peer-reviewed academic journals.Trial registration numberjRCTs041220126.

30 Nov 2023·Clinical Kidney Journal

Phase 2 study of upacicalcet in Japanese haemodialysis patients with secondary hyperparathyroidism: an intraindividual dose-adjustment study

Article

Author: Asano, Kenji ; Tokumoto, Masanori ; Hagita, Keiko ; Inagaki, Yosuke ; Yasuzawa, Hisami ; Yoneda, Shinji ; Fukagawa, Masafumi ; Honda, Daisuke ; Inaguma, Daijo ; Akizawa, Tadao ; Koiwa, Fumihiko

ABSTRACTBackgroundUpacicalcet is a novel small-molecule calcimimetic agent developed for intravenous injection. Here, we evaluated the long-term efficacy and safety of upacicalcet treatment via intraindividual dose adjustment in haemodialysis patients with secondary hyperparathyroidism (SHPT).MethodsA phase 2, multicentre, open-label, single-arm study was conducted. Upacicalcet was administered for 52 weeks; the starting dose was 50 μg thrice a week, and then adjusted to 25, 50, 100, 150, 200, 250, or 300 μg, according to the dose-adjustment method set in the protocol. The primary endpoint was the percentage of patients with serum intact parathyroid hormone (iPTH) level achieving a target range of 60–240 pg/mL (target achievement rate) at week 18.ResultsA total of 58 patients were administered upacicalcet. The target achievement rate of serum iPTH level at week 18 was 57.9%, which increased to 80.8% at week 52. The serum-corrected calcium (cCa) level decreased immediately after upacicalcet administration, but no further decrease was observed. Adverse events were observed in 94.8% of patients, and adverse drug reactions (ADRs) occurred in 20.7% of patients. The most common ADR was decreased adjusted calcium in eight patients; dizziness occurred as a serious ADR in one patient. The serum cCa level of patients who interrupted upacicalcet treatment at a serum cCa level of <7.5 mg/dL recovered to ≥7.5 mg/dL immediately after the interruption.ConclusionsIn haemodialysis patients with SHPT, upacicalcet doses of 25–300 μg for 52 weeks were found to be highly effective and well-tolerated, with minor safety concerns.

News (Medical) associated with Upacicalcet Sodium Hydrate

21 Aug 2024

·www.pharmaceutical-technology.com

Pathalys secures $105m to advance SHPT drug through approval

Pathalys has closed a $105m Series B financing round led by TCGX. Credit: PeopleImages.com – Yuri A via Shutterstock. Pathalys Pharma has secured $105m in a Series B financing round to support its clinical trials, file a new drug application (NDA) with the US Food and Drug Administration (FDA), and accelerate preapproval commercialisation preparations. The company’s lead candidate is upacicalcet, a drug used to treat secondary hyperparathyroidism (SHPT) in patients undergoing dialysis due to chronic kidney disease (CKD). The calcimimetic drug mirrors the action of calcium on tissues, particularly the parathyroid glands. The medication is typically administered during dialysis sessions. Earlier this year, Pathalys launched two identical Phase III studies of upacicalcet, which will both enrol 375 patients. The PATH study program is designed to assess the efficacy of upacicalcet as measured by its ability to reduce intact parathyroid hormone (iPTH) by 30% or more in participants with SHPT and currently on haemodialysis. The funding round, led by TCGX, is set to support these clinical trials, and advance the candidate towards approval. The drug is already approved to treat SHPT in Japan, securing the green light in 2021. Others included in the round were JP Morgan Life Sciences Private Capital, Samsara BioCapital, Marshall Wace, KB Investment, JPS Growth Investment Limited Partnership, Catalys Pacific, and DaVita Venture Group. SHPT is a condition where the parathyroid glands , which are small glands located in the neck, produce excessive amounts of PTH. This overproduction occurs as a response to low calcium levels in the blood. The most common cause of this is chronic kidney disease (CKD). As the kidneys fail, they are less able to convert vitamin D into its active form, which is necessary for calcium absorption. See Also: FDA approves updated mRNA vaccines for Covid-19 Verve Therapeutics gets grant for gene editing compositions to lower ldl cholesterol levels The first approved calcimimetic drug was Amgen ’s Sensipar (cinacalcet). Similar to upacicalcet, it lowers PTH levels by increasing the sensitivity of the parathyroid gland to calcium. Amgen also has Parsabiv (etelcalcetide) in its portfolio, which is delivered intravenously during dialysis sessions. Parsabiv pulled in $362m in sales for Amgen in 2023, as per the company’s financials. In the announcement accompanying the funding, Pathalys’s CEO Neal Fowler said: “Since our inception, Pathalys has made significant strides toward our goal of delivering a best-in-class treatment for those with end-stage kidney disease (ESKD), including the near completion of two Phase III clinical trials for upacicalcet.” “We believe the continued expansion of our syndicate of prominent life science investors, with representative board members, is indicative of the fact that we are on the right path at Pathalys.”

Phase 3VaccineDrug Approval

20 Aug 2024

·www.fiercebiotech.com

Pathalys raises $105M series B to prepare Japan-approved kidney disease drug for FDA

Research Triangle Park, North Carolina-based Pathalys Pharma previously brought in $150 million in January 2023 via a combination of secured product financing and equity. Pathalys Pharma has brought in $105 million via a series B fundraise that the kidney-disease-focused biotech will use to take its lead candidate through the final stages of clinical development.The company’s primary focus is upacicalcet, a calcimimetic with the potential to improve the treatment of secondary hyperparathyroidism (SHPT) in hemodialysis patients. Calcimimetics, such as Amgen’s approved SHPT drug Sensipar, mimic calcium's action on tissues in order to treat disorders related to calcium homeostasis or skeletal integrity.In May, Pathalys launched upacicalcet into two identical 375-person phase 3 trials for SHPT. The common, but serious, complication of chronic kidney disease is often seen in patients on hemodialysis. Upacicalcet is already approved for SHPT in Japan, where the drug “performed exceptionally well” in late-stage studies, Pathalys said earlier this year.The new funds will be used to finalize those studies as well as begin the process of preparing an approval submission to the FDA and the “acceleration of preapproval commercialization preparations,” the biotech explained in an Aug. 20 release. The oversubscribed round was led by TCGX with participation from the likes of J.P. Morgan Life Sciences Private Capital, Samsara BioCapital, Marshall Wace, KB Investment and JPS Growth Investment Limited Partnership. Pathalys’ co-founders Catalys Pacific and DaVita Venture Group were also both involved.The financing will see three additions to Pathalys’ board, including Joe Siletto, managing partner of J.P. Morgan Life Sciences Private Capital. “Since our inception, Pathalys has made significant strides toward our goal of delivering a best-in-class treatment for those with end-stage kidney disease (ESKD), including the near completion of two phase 3 clinical trials for upacicalcet,” Pathalys CEO Neal Fowler said in the Aug. 20 release.“We believe the continued expansion of our syndicate of prominent life science investors, with representative board members, is indicative of the fact that we are on the right path at Pathalys,” Fowler added.The Research Triangle Park, North Carolina-based biotech previously brought in $150 million in January 2023 via a combination of secured product financing and equity.

Drug ApprovalPhase 3

20 Aug 2024

·firstwordpharma.com

Pathalys secures $105M to bring kidney disease hopeful over the finish line

As two pivotal trials of its kidney disease therapy draw to a close, Pathalys Pharma has raised $105 million in a series B to fund a planned new drug application (NDA) submission with the FDA and begin pre-commercialisation activities. Led by TCGX, the round also saw participation from JP Morgan Life Sciences Private Capital, Samsara BioCapital, Marshall Wace, KB Investment, and JPS Growth Investment Limited Partnership. The biotech’s founding investors Catalys Pacific and DaVita Venture Group — which launched Pathalys in 2022 with ex-Asia rights to upacicalcet from EA Pharma — also backed the financing. Upacicalcet is a calcimimetic intended to help patients with secondary hyperparathyroidism (SHPT) control their intact parathyroid hormone levels (iPTH). Delivered intravenously at the end of a haemodialysis session, the candidate is designed to offer a better tolerability profile than currently available calcimimetic agents.Pathalys is running two identical, 27-week, double-blind, placebo-controlled Phase III studies to support approval of upacicalcet for patients with SHPT due to end-stage kidney disease (ESKD). According to ClinicalTrials.gov, the trials are expected to wrap next July.Upacicalcet is approved in Japan as Upasita based on data demonstrating the drug’s ability to reduce iPTH and maintain long-term iPTH suppression with fewer adverse events than currently available therapies.

Phase 3NDADrug Approval

100 Deals associated with Upacicalcet Sodium Hydrate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Upacicalcet Sodium Hydrate	-	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hyperparathyroidism, Secondary	JP	Sanwa Kagaku Kenkyusho Co., Ltd.	23 Jun 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hyperparathyroidism, Secondary	Phase 3	US	Pathalys Pharma, Inc.Startup	28 Apr 2023
Kidney Failure, Chronic	Phase 3	BG	Pathalys Pharma, Inc.Startup	28 Apr 2023
Kidney Failure, Chronic	Phase 3	PT	Pathalys Pharma, Inc.Startup	28 Apr 2023
Kidney Failure, Chronic	Phase 3	RS	Pathalys Pharma, Inc.Startup	28 Apr 2023
Kidney Failure, Chronic	Phase 3	ES	Pathalys Pharma, Inc.Startup	28 Apr 2023
Kidney Failure, Chronic	Phase 3	US	Pathalys Pharma, Inc.Startup	28 Apr 2023
Kidney Failure, Chronic	Phase 3	PL	Pathalys Pharma, Inc.Startup	28 Apr 2023
Hyperparathyroidism	Phase 3	-	EA Pharma Co., Ltd.	-
Hyperparathyroidism	Phase 3	-	JW PHARMACEUTICAL Corp.	-
Hyperparathyroidism	Phase 3	-	Tasly Pharmaceutical Group Co., Ltd.	-

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASN2020	Not Applicable	Hyperparathyroidism, Secondary	-	Upacicalcet 0.3 mg/kg	rpfmvtxzww(qlriobtqos) = ldrulsdhkf zchkwooukv (bfomadmcgk )	-	19 Oct 2020
				Upacicalcet 3 mg/kg	rpfmvtxzww(qlriobtqos) = pdckhgeaib zchkwooukv (bfomadmcgk )

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