[Translation] A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of the mineralocorticoid receptor antagonist KBP-5074 in subjects with moderate or severe (stage 3b/4) chronic kidney disease (CKD) and uncontrolled hypertension

本研究的主要目的是评估 KBP-5074 在降低收缩压（SBP）方面的有效性和持久性。本研究的次要目的是：评估 KBP-5074 对舒张压（DBP）和尿白蛋白/肌酐比（UACR）的影响；评估 KBP-5074 的安全性和耐受性。

[Translation]

The primary objective of this study is to evaluate the efficacy and durability of KBP-5074 in reducing systolic blood pressure (SBP). The secondary objectives of this study are: to evaluate the effect of KBP-5074 on diastolic blood pressure (DBP) and urine albumin/creatinine ratio (UACR); and to evaluate the safety and tolerability of KBP-5074.

Start Date22 Feb 2023

Sponsor / Collaborator

Shandong Hengli Medicine Science & Technology Co., Ltd.

NCT04968184 / TerminatedPhase 3

A Phase 3 Randomized Double-Blind Placebo-Controlled Multicenter Study to Assess the Efficacy and Safety of KBP-5074 Mineralocorticoid Receptor Antagonist in Subjects With Uncontrolled Hypertension and Moderate or Severe (Stage 3b/4) CKD

This Phase 3, randomized, Double-blind, placebo-controlled, 2-arm, parallel-group, multicenter study with randomized withdrawal will evaluate the efficacy, safety, and durability of KBP-5074 in adult participants who have stage 3b/4 chronic kidney disease (CKD) (estimated glomerular filtration rate [eGFR] calculated using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula [eGFR {EPI}] ≥15 to ≤44 mL/min/1.73 m^2) and uncontrolled hypertension (systolic blood pressure (SBP) ≥140 and <180 mm Hg and taking 2 or more antihypertensive medications.

Start Date05 Nov 2021

Sponsor / Collaborator

KBP Biosciences USA, Inc.

NCT04634812 / CompletedPhase 1

A Phase 1, Open-label, Study of the Absorption, Metabolism, and Excretion of [14C]-KBP-5074 Following a Single Oral Dose in Healthy Male Subjects

This is a Phase 1, open-label, nonrandomized, single-dose mass balance and metabolite identification study in healthy male subjects.

Start Date03 Dec 2020

Sponsor / Collaborator

KBP Biosciences USA, Inc.

[+1]

100 Clinical Results associated with Ocedurenone

100 Translational Medicine associated with Ocedurenone

100 Patents (Medical) associated with Ocedurenone

Literatures (Medical) associated with Ocedurenone

01 Nov 2024·Heart (British Cardiac Society)

Diagnosis and management of resistant hypertension

Review

Author: Kreutz, Reinhold ; Cho, Myeong-Chan ; Camafort, Miguel

Resistant hypertension is a condition where blood pressure levels remain elevated above target despite changes in lifestyle and concurrent use of at least three antihypertensive agents, including a long-acting calcium channel blocker (CCB), a blocker of the renin-angiotensin system (ACE inhibitor or angiotensin receptor blocker) and a diuretic. To be diagnosed as resistant hypertension, maintaining adherence to therapy is required along with confirmation of blood pressure levels above target by out-of-office blood pressure measurements and exclusion of secondary causes of hypertension. The key management points of this condition include lifestyle changes such as reduced sodium and alcohol intake, regular physical activity, weight loss and discontinuation of substances that can interfere with blood pressure control. It is also recommended that current treatment be rationalised, including single pill combination treatment where antihypertensive drugs should be provided at the maximum tolerated dose. It is further recommended that current drugs be replaced with a more appropriate and less difficult treatment regimen based on the patient’s age, ethnicity, comorbidities and risk of drug–drug interactions. The fourth line of treatment for patients with resistant hypertension should include mineralocorticoid receptor antagonists such as spironolactone, as demonstrated in the PATHWAY-2 trial and meta-analyses. Alternatives to spironolactone include amiloride, doxazosin, eplerenone, clonidine and beta-blockers, as well as any other antihypertensive drugs not already in use. New approaches under research are selective non-steroidal mineralocorticoid receptor antagonists such as finerenone, esaxerenone and ocedurenone, selective aldosterone synthase inhibitors such as baxdrostat, and dual endothelin antagonist aprocitentan.

01 Jun 2024·Journal of Diabetes

Renal effects and safety between Asian and non‐Asian chronic kidney disease and type 2 diabetes treated with nonsteroidal mineralocorticoid antagonists

Article

Author: Liao, Lin ; Feng, Jing ; Cui, Yuying ; Xu, Xiaoming ; Dong, Jianjun ; Li, Pingjiang

Abstract:

Background:

Asians bear a heavier burden of chronic kidney disease (CKD), a common comorbidity of type 2 diabetes mellitus (T2DM), than non‐Asians. Nonsteroidal mineralocorticoid receptor antagonists (MRAs) have garnered attention for their potential advantages in renal outcomes. Nevertheless, the impact on diverse ethnic groups remains unknown.

Methods:

The PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang database, and clinical trial registries were searched through August 2023 with the following keywords: nonsteroidal MRAs (finerenone, apararenone, esaxerenone, AZD9977, KBP‐5074), CKD, T2DM, and randomized controlled trial (RCT). A random effects model was used to calculate overall effect sizes.

Results:

Seven RCTs with 14 997 participants were enrolled. Nonsteroidal MRAs reduced urinary albumin to creatinine ratio (UACR) significantly more in Asians than non‐Asians: (weighted mean difference [WMD], −0.59, 95% CI, −0.73 to −0.45, p < .01) vs (WMD, −0.29, 95% CI, −0.32 to −0.27, p < .01), respectively. The average decline of estimated glomerular filtration rate (eGFR) was similar in Asians and non‐Asians (p > .05). Regarding systolic blood pressure (SBP), nonsteroidal MRAs had a better antihypertension performance in Asians (WMD, −5.12, 95% CI, −5.84 to −4.41, p < .01) compared to non‐Asians (WMD, −3.64, 95% CI, −4.38 to −2.89, p < .01). A higher incidence of hyperkalemia and eGFR decrease ≥30% was found in Asians than non‐Asians (p < .01).

Conclusions:

Nonsteroidal MRAs exhibited significant renal benefits by decreasing UACR and lowering SBP in Asian than that of non‐Asian patients with CKD and T2DM, without increase of adverse events except hyperkalemia and eGFR decrease ≥30%.image

01 Mar 2024·European journal of drug metabolism and pharmacokinetics

Pharmacokinetics of the Novel Nonsteroidal Mineralocorticoid Receptor Antagonist Ocedurenone (KBP-5074) in Individuals with Moderate Hepatic Impairment

Article

Author: Yang, Fred ; McCabe, James ; Zhang, Jay ; Benn, Vincent

BACKGROUND AND OBJECTIVES:

Ocedurenone (KBP-5074) is a novel nonsteroidal mineralocorticoid receptor antagonist that has demonstrated safety and efficacy in clinical trials in patients with uncontrolled hypertension and stage 3b/4 chronic kidney disease. The aim of this study was to assess the pharmacokinetics, safety, and tolerability of ocedurenone in individuals with moderate hepatic impairment.

METHODS:

This study was an open-label, nonrandomized, multi-center study investigating the pharmacokinetics, safety, and tolerability of a single dose of 0.5 mg ocedurenone administered orally in male and female subjects with moderate hepatic impairment (Child-Pugh B, score 7-9) compared with subjects with normal hepatic function. Serial blood samples were obtained from predose through 264 h postdose for analysis of ocedurenone concentrations using a validated liquid chromatography-tandem mass spectrometry method. Free ocedurenone concentrations in plasma were determined ex vivo using equilibrium dialysis.

RESULTS:

Following a single oral dose of 0.5 mg ocedurenone administered to subjects with moderate hepatic impairment and subjects with normal hepatic function, ocedurenone was steadily absorbed with median time to peak drug concentration (T_max) values of 4 and 3 h, respectively. After reaching maximum plasma concentration (C_max), the disposition of ocedurenone appeared to be biphasic. The geometric mean t_1/2 values for the moderate hepatic impairment group and normal hepatic function group were 75.6 and 65.7 h, respectively. Ocedurenone systemic exposure, as assessed by area under the plasma concentration-time curve (AUC) was 23.5-26.6% lower in subjects with moderate hepatic impairment versus subjects with normal hepatic function, whereas C_max was 41.2% lower. Ocedurenone was determined to be > 99.7% bound to total protein in plasma. Hepatic impairment appeared not to change plasma protein binding or the unbound free fraction. Ocedurenone was safe and well-tolerated in all participants.

CONCLUSIONS:

Considering the long half-life of ocedurenone and previously completed clinical studies using 0.25 mg and 0.5 mg doses demonstrating efficacy and safety, the observed decreases in AUC and C_max do not warrant a dose adjustment in patients with moderate hepatic impairment. A single 0.5 mg dose of ocedurenone was safe and well-tolerated when administered to subjects with moderate hepatic impairment and subjects with normal hepatic function. CLINICAL TRIAL IDENTIFIER ( WWW.

CLINICALTRIALS:

GOV ): NCT04534699.

News (Medical) associated with Ocedurenone

06 Nov 2024

·endpts.com

Novo unveils new cardiometabolic data as it reports solid third-quarter profits

Novo Nordisk disclosed several key updates from its cardiometabolic and hematology pipelines Wednesday as the drugmaker revealed its third-quarter profits edged out expectations. First up, the Danish pharma giant said semaglutide met the primary endpoint of a Phase 3b trial in people with peripheral arterial disease (PAD) and type 2 diabetes. At 52 weeks, 13% of people given semaglutide saw a “statistically significant” improvement in their maximum walking distance compared with placebo, according to a Wednesday release . Novo said it plans to file for approval of Ozempic in PAD in the first half of next year. Also in the diabetes space, the company’s DNA immunotherapy candidate has a safe and well-tolerated profile based on a Phase 1 test in August. The treatment is designed to preserve the body’s natural production of insulin and thus slow down or stop type 1 diabetes in people at high risk of developing it. The company has yet to spell out what it plans to do with the asset. On the hematology side, the Danish drugmaker said it is gearing up to file for approval for its hemophilia A prophylactic therapy next year. The treatment, dubbed Mim8, led to better annualized bleeding rates in a Phase 3b trial comparing it with standard-of-care emicizumab. Novo also said it terminated overall development of its mineralocorticoid receptor antagonist, named ocedurenone, after stopping a Phase 3 trial in chronic kidney disease earlier this year. The trial came to an end in June after it was deemed unable to meet its endpoints. Elsewhere, the Danish drugmaker’s Q3 performance appears to be better than Eli Lilly’s, with net profits coming in just ahead of the Wall Street consensus of DKK 27 billion ($3.9 billion). By contrast, Lilly’s total Q3 revenues of $11.4 billion missed its $12.2 billion consensus forecast. Novo’s shares $NVO rallied as much as 4% premarket Wednesday. The drugmaker narrowed its expectations for 2024 sales growth to between 23% and 27% from an original range of 22% to 28%. The revision comes after the company trimmed its guidance for profit growth in the second quarter. Both Novo and Lilly are facing competitive pressures from companies making compounded versions of their blockbuster diabetes and weight loss drugs. But Novo, during its earnings call with the media, underscored safety issues with these compounded drugs. “We have been looking at a number of compounded products in the market and identified multiple safety concerns and also noted more than 100 hospitalizations and 10 deaths based on compounded semaglutides,” CFO Karsten Munk Knudsen said. Last month, a trade group of compounding pharmacies sued the FDA for taking Eli Lilly’s tirzepatide off its shortage list despite some evidence that the drug was still in short supply.

Phase 3Clinical ResultImmunotherapyPhase 1Financial Statement

06 Nov 2024

·firstwordpharma.com

Investor concerns allayed as Novo overcomes Wegovy 'blip'

Novo Nordisk's flagship obesity treatment Wegovy returned to forecast-topping growth in the company's latest financial results, sending shares up more than 8% on Wednesday. Sales of the GLP-1 product surged 79% in the third quarter to DKK 17.3 billion ($2.5 billion), well above consensus expectations of DKK 15.9 billion.While sales of Wegovy had grown 55% in the previous quarter to DKK 11.7 billion, they came in below consensus estimates of DKK 13.5 billion — a "blip" that Novo attributed to an adjustment of rebates related to estimates made on the prior year's revenue.And ahead of Novo's latest financial print, fears of a repeat in the third quarter had been stoked by Eli Lilly's disappointing sales figures for its competing GLP-1/GIP co-agonist products Mounjaro and Zepbound. Revenue for the two came in below analyst predictions, which Lilly blamed on inventory decreases in the US wholesaler channel. On Wednesday, Novo CEO Lars Fruergaard Jørgensen said that the pharma continues to see "very significant demand" for Wegovy in the US and is working hard to increase manufacturing capacity. However, the company warned that despite earmarking billions of dollars to invest in production, it still faces "capacity limitations" at some sites, along with "periodic supply constraints and related drug-shortage notifications."Weak diabetes sales"Wegovy continues to gain momentum and clearly exceeds expectations in the quarter," compensating for weaker diabetes sales, remarked Sydbank analyst Søren Løntoft Hansen. "This is good enough to provide some relief," added Emily Field of Barclays, explaining that Wegovy's beat came despite slightly worse pricing in the US than anticipated.Novo's overall sales and profit both increased 21% in the third quarter to DKK 71.3 billion and DKK 27.3 billion, respectively. However, the revenue figure came in below analyst projections of DKK 72.3 billion, partly due to lacklustre growth in its diabetes segment, including for Ozempic.In the quarter, Ozempic — which contains the same active ingredient as Wegovy — generated sales of DKK 29.8 billion, up 26% year-over-year at constant currencies, but below forecasts of DKK 30.5 billion.Guidance narrowedFor the full year, Novo said it now expects sales growth of between 23% and 27% on a constant exchange rate basis, narrowed from a prior range of 22% to 28%. Meanwhile, operating profit growth was similarly revised, and is now seen between 21% and 27%, from previous guidance of 20% to 28%.Investors had feared the drugmaker would cut its outlook, noted Terence McManus of Bellevue Asset Management. "However, we don't see these results as an all-clear signal on the stock," he added, with all eyes now set to turn to pending late-stage data for its next obesity hopeful dubbed CagriSema.The therapy, which combines semaglutide — the active ingredient in Ozempic and Wegovy — with the amylin analogue cagrilintide, is expected to lead to weight loss of over 15% when results are unveiled later this year. Martin Holst Lange, Novo's development head, reaffirmed that CagriSema has potential for up to 25% weight loss, with "no change in our confidence level."Other pipeline updatesNovo also disclosed alongside its financial print that the Phase IIIb STRIDE study of Ozempic as an adjunct to standard of care in people with type 2 diabetes and peripheral arterial disease with intermittent claudication met its primary endpoint. The drug demonstrated a clinically relevant and statistically significant improvement in maximum walking distance of 13% compared to placebo. US and EU marketing applications in this indication are targeted for the first half of 2025.Additionally, the company plans regulatory filings next year for its factor VIIIa mimetic bispecific antibody Mim8 in haemophilia A. Following up on the positive Phase IIIa FRONTIER 2 trial, Novo said Wednesday that the Phase IIIb FRONTIER 5 study has now been completed. The trial assessed switching from prophylaxis with Roche's once-weekly therapy Hemlibra (emicizumab) to Mim8 — something Novo reported was well tolerated.Elsewhere, Novo said it has now decided to bin development of the non-steroidal mineralocorticoid receptor antagonist ocedurenone across all indications. The future of the asset — gained from KBP Biosciences for up to $1.3 billion — was under review following the failure in June of the Phase III CLARION-CKD study in patients with uncontrolled hypertension and advanced chronic kidney disease.($1 = DKK 6.92889)

Phase 3Financial Statement

07 Aug 2024

·www.globenewswire.com

Novo Nordisk's sales increased by 24% in Danish kroner and by 25% at constant exchange rates to DKK 133.4 billion in the first six months of 2024

Bagsværd, 7 August 2024 - Financial report for the period 1 January 2024 to 30 June 2024 Operating profit increased by 18% in Danish kroner and by 19% at constant exchange rates (CER) to DKK 57.8 billion. Operating profit is impacted by the impairment loss related to ocedurenone of DKK 5.7 billion. Sales in North America Operations increased by 36% in Danish kroner (36% at CER). Sales growth in the US was positively impacted by gross-to-net sales adjustments related to prior years. Sales in International Operations increased by 9% in Danish kroner (11% at CER).Sales within Diabetes and Obesity care increased by 26% in Danish kroner to DKK 125.0 billion (27% at CER), mainly driven by GLP-1 diabetes sales growth of 32% in Danish kroner (32% at CER) and Obesity care growing by 37% in Danish kroner to DKK 24.9 billion (37% at CER). Rare disease sales decreased by 4% measured in Danish kroner (3% at CER).Within R&D, Novo Nordisk successfully completed the phase 3 FRONTIER 2 trial with Mim8, where once-weekly and once-monthly Mim8 demonstrated superior reduction of treated bleeding episodes compared to on-demand and prior prophylaxis treatment in people with haemophilia A. In June 2024, Novo Nordisk announced that the ocedurenone CLARION-CKD phase 3 trial was stopped, as ocedurenone failed to meet the primary endpoint.Also within R&D, Novo Nordisk received a Complete Response Letter from the Food and Drug Administration (FDA) for insulin icodec in July. In Obesity care, Novo Nordisk received a positive CHMP opinion, based on the SELECT trial, for an update of the Wegovy® label to reflect risk reduction of major adverse cardiovascular events in the EU.For the 2024 outlook, sales growth is now expected to be 22-28% at CER, and operating profit growth is now expected to be 20-28% at CER. Growth reported in Danish kroner is now expected to be 1 percentage point lower than at CER growth for both sales and operating profit. PROFIT AND LOSSH1 2024H1 2023Growthas reportedGrowthat CER*DKK million Net sales 133,409 107,667 24% 25% Operating profit 57,780 48,895 18% 19% Net profit 45,457 39,242 16% N/ADiluted earnings per share (in DKK) 10.17 8.71 17% N/A* CER: Constant exchange rates (average 2023). Lars Fruergaard Jørgensen, president and CEO: "We are pleased with the sales growth in the first half of 2024, which has enabled us to raise the outlook for the full year. The growth is driven by the increased demand for our GLP-1-based diabetes and obesity treatments, and we continue to reach more patients with our innovative treatments. Within R&D, we are very pleased with the first phase 3 trial results with Mim8 and its potential for people living with haemophilia A, and with the recent recommendation for a label extension for cardiovascular risk reduction for Wegovy® in the EU." About Novo Nordisk Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 69,000 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown+45 3079 9289abmo@novonordisk.comLiz Skrbkova (US)+1 609 917 0632lzsk@novonordisk.com Investors: Jacob Martin Wiborg Rode+45 3075 5956jrde@novonordisk.comDavid Heiberg Landsted+45 3077 6915dhel@novonordisk.comSina Meyer+45 3075 6656azey@novonordisk.comMark Joseph Root (US)+1 848 213 3219mjhr@novonordisk.comIda Schaap Melvold+45 3077 5649idmg@novonordisk.comFrederik Taylor Pitter+45 3075 8259fptr@novonordisk.com Company announcement No 58 / 2024 Attachment PR240807-Q2

Phase 3Financial StatementClinical Result

100 Deals associated with Ocedurenone

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic Kidney Diseases	Phase 3	US	KBP Biosciences USA, Inc.	05 Nov 2021
Chronic Kidney Diseases	Phase 3	CN	KBP Biosciences USA, Inc.	05 Nov 2021
Chronic Kidney Diseases	Phase 3	AU	KBP Biosciences USA, Inc.	05 Nov 2021
Chronic Kidney Diseases	Phase 3	BA	KBP Biosciences USA, Inc.	05 Nov 2021
Chronic Kidney Diseases	Phase 3	BG	KBP Biosciences USA, Inc.	05 Nov 2021
Chronic Kidney Diseases	Phase 3	CA	KBP Biosciences USA, Inc.	05 Nov 2021
Chronic Kidney Diseases	Phase 3	HR	KBP Biosciences USA, Inc.	05 Nov 2021
Chronic Kidney Diseases	Phase 3	CZ	KBP Biosciences USA, Inc.	05 Nov 2021
Chronic Kidney Diseases	Phase 3	GE	KBP Biosciences USA, Inc.	05 Nov 2021
Chronic Kidney Diseases	Phase 3	DE	KBP Biosciences USA, Inc.	05 Nov 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04968184 (CLARION-CKD, NEWS) Manual	Phase 3	Hypertension \| Chronic Kidney Diseases	600	ocedurenone	qgfdjyjyyv(vveuyixlow) = failed to meet its primary endpoint sdzzqfnjkh (ulepemiwvu ) Not Met	Negative	27 Jun 2024
ASN2022	Not Applicable	Hepatic Insufficiency	-	KBP-5074 0.5 mg	zulyzrmklm(kwffznywdx) = wnivuguvjr ecrzjgnava (glmgqiqyno ) View more	Positive	04 Nov 2022
				KBP-5074	zulyzrmklm(kwffznywdx) = eddxysdoeo ecrzjgnava (glmgqiqyno ) View more
NCT03574363 (BLOCK-CKD, Pubmed \| Curr Hypertens Rep)	Phase 2	Chronic Kidney Diseases	162	Placebo	pnkvgjpfwl(dswhgneqgd) = jujpupdqww ybhszfxkmj (zwryzxaupa )	Positive	10 May 2021
				KBP-5074 0.25 mg	pnkvgjpfwl(dswhgneqgd) = sqywdmvusb ybhszfxkmj (zwryzxaupa )
NCT02837237 (CTgov)	Phase 1	Chronic Kidney Diseases	11	KBP-5074	exqcfvjumc(imvhrgseuz) = kzmwxnxdxz czsgvbfpla (wgaarimctf, lvhiscbryn - wlteljwzyb) View more	-	15 Oct 2019
Phase 1 (ASN2017)	Phase 1	Chronic Kidney Diseases	11	KBP-5074 0.5 mg	iitovhvrkh(oaijvnvvrx) = hmbzjmfnxb wbtwhrnmtz (acfzuckeyk ) View more	Positive	31 Oct 2017
				KBP-5074	iitovhvrkh(oaijvnvvrx) = scbyskqcvo wbtwhrnmtz (acfzuckeyk ) View more
ASN2016	Not Applicable	Chronic Kidney Diseases	14	KBP-5074 0.5 mg	ejrzzffgyz(gakdqezrit) = 2 subjects in the 2.5 mg group developed hyperkalemia (serum potassium >5.5 mmol/L); 1 subject in the 0.5 mg group with baseline serum potassium 5.0 mmol/L also developed hyperkalemia on study. These three subjects continued in the study. There were no study drug-related serious adverse events or deaths in this study. pwhfdglprt (alvqfcmxid )	Positive	15 Nov 2016
				KBP-5074 2.5 mg

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