Chronic Kidney Disease - Competitive landscape, 2023

This “Chronic Kidney Disease - Competitive landscape, 2023” report provides comprehensive insights about 75+ companies and 95+ drugs in Chronic Kidney Disease Competitive landscape. It covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Chronic Kidney Disease: Understanding

Chronic Kidney Disease: Overview

Chronic Kidney Disease is a condition in which kidneys are damaged and cannot filter blood. As a result, extra fluid and waste from the blood remain in the body, potentially leading to various health issues like heart disease and stroke. Chronic Kidney Disease has various levels of seriousness. It usually gets worse with time though treatment has been shown to slow progression. If left untreated, CKD can progress to kidney failure and early cardiovascular disease. People with chronic kidney disease may not feel ill or notice any symptoms. CKD signs and symptoms develop over time if kidney damage progresses slowly. Loss of kidney function can cause a buildup of fluid or body waste or electrolyte problems. The most common symptoms of chronic kidney disease include: hypertension, anemia, edema, fatigue, decreased urine output, blood in urine, dark urine, loss of appetite and persistent itchy skin. The most common cause of chronic kidney disease is diabetes and high blood pressure. Each kidney contains about 1 million tiny filtering units, called nephrons. Any disease that injures or scars the nephrons can cause kidney disease. Diabetes and high blood pressure can both damage the nephrons. High blood pressure can also damage the blood vessels of your kidneys, heart, and brain. The kidneys are highly vascularized, meaning they contain lots of blood vessels. So, blood vessel diseases are generally dangerous to your kidneys. If uncontrolled, or poorly controlled, high blood pressure can be a leading cause of heart attacks, strokes and chronic kidney disease. Also, chronic kidney disease can cause high blood pressure. Chronic kidney disease (CKD) refers to all 5 stages of kidney damage, from very mild damage in Stage 1 to complete kidney failure in Stage 5. Physicians determine the stage of kidney disease using the glomerular filtration rate (GFR), a math formula using a person's age, gender, and their serum creatinine level. Creatinine, a waste product that comes from muscle activity, is a key indicator of kidney function. When kidneys are working well they remove creatinine from the blood; but as kidney function slows, blood levels of creatinine rise. CKD normally has no symptoms until the kidneys are severely damaged. Timely and routine testing is the only way to find out how well the kidney is functioning. The majority of people are diagnosed using blood and urine. These tests may be performed as part of a standard check-up or if you are at risk of developing CKD. The tests check for abnormally high levels of particular compounds such as GFR and protein in the blood and urine, which indicate that your kidneys aren't functioning properly. The results value indicates the severity of kidney disease, with a larger value signifying more severe CKD.

Report Highlights

• In March 2023, POXEL SA, announced the publication of preclinical results in autosomal dominant polycystic kidney disease (ADPKD) for PXL770, a novel, first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator. For the first time, POXEL SA showed beneficial effects of a direct and selective AMPK activator in preclinical ADPKD models from three species mouse, human, and dog. These results confirm the potential utility of AMPK activation for this disease and support the development of PXL770 in a Phase 2 clinical program for ADPKD.
• In February 2023, AstraZeneca announced the successful completion of the acquisition of CinCor Pharma, Inc. The acquisition bolsters AstraZeneca's cardiorenal pipeline by adding baxdrostat (CIN-107), an aldosterone synthase inhibitor (ASI) for blood pressure lowering in treatment-resistant hypertension, to its cardiorenal portfolio.
• In January 2023, The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets, which is being investigated as a potential treatment to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease (CKD), Boehringer Ingelheim and Eli Lilly and Company announced.
• In November 2022, The Medical Research Council Population Health Research Unit (MRC PHRU) at the University of Oxford, which designed, conducted and analyzed EMPA-KIDNEY in a scientific collaboration with Boehringer Ingelheim and Eli Lilly and Company, announced that EMPA-KIDNEY phase III clinical trial met its primary endpoint by demonstrating a significant kidney and cardiovascular benefit for adults living with chronic kidney disease (CKD). When treated with Jardiance® (empagliflozin), the risk of kidney disease progression or cardiovascular death was significantly reduced by 28% vs. placebo (HR; 0.72; 95% CI 0.64 to 0.82; P< 0.0001).
• In October 2022, Revelation Biosciences Inc. announced positive results in a preclinical model of acute kidney injury (AKI), chronic kidney disease (CKD). Treatment with REVTx-300 significantly reduced renal cortical fibrosis in a dose dependent manner in the medium and high dose groups (21.7% reduction (p < 0.05) and 29.3% (p < 0.05), respectively) and was comparable to a known TGF-β inhibitor of fibrosis used as a positive control (38.1% reduction (P < 0.05)).
• In October 2022, French Biopharma Company, Poxel SA announced the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to PXL770 for the treatment of patients with autosomal-dominant polycystic kidney disease (ADPKD). PXL770 is a novel, first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator - and is also a phase 2 ready ADPKD asset, subject to additional financing.

Chronic Kidney Disease: Company and Product Profiles (Marketed Therapies)

1. Company Overview: AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries, and its innovative medicines are used by millions of patients worldwide. Cardiovascular, Renal and Metabolism (CVRM), part of BioPharmaceuticals, forms one of AstraZeneca's main disease areas and is a key growth driver for the Company. By following the science to understand more clearly the underlying links between the heart, kidneys and pancreas, AstraZeneca is investing in a portfolio of medicines for organ protection and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities. The Company's ambition is to modify or halt the natural course of CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and CV health for millions of patients worldwide.

Product Description: Forxiga

Forxiga (dapagliflozin) is a first-in-class, oral, once-daily SGLT2 inhibitor. Research has shown Forxiga's efficacy in preventing and delaying cardiorenal disease, while also protecting the organs - important findings given the underlying links between the heart, kidneys and pancreas. Forxiga is approved as an adjunct to diet and exercise to improve glycaemic control in adults with T2D and in T2D to reduce the risk of hHF or CV death when added to SoC based on the findings of the DECLARE-TIMI Phase III CV outcomes trial. Forxiga is also approved for the treatment of HFrEF and the treatment of CKD based on the findings of the DAPA-HF and DAPA-CKD Phase III trials. In November 2022, the Central Drugs Standard Control Organization's (CDCSCO) approved Dapagliflozin in the treatment of adults with chronic kidney disease (CKD). Dapagliflozin is the first and only anti-diabetic drug approved to significantly reduce the risk of sustained eGFR (estimated Glomerular Filtration Rate), cardiovascular deaths and hospitalizations due to heart failure in adults with progressive chronic kidney disease. This approval is applicable for both diabetic and non-diabetic CKD patients. In May 2021, US Food and Drug Administration (FDA) has approved AstraZeneca's Farxiga (dapagliflozin) for treating chronic kidney disease (CKD) in patients who are at the risk of progression with and without type-2 diabetes. Farxiga can be used for lowering the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease (ESKD), cardiovascular (CV) death and hospitalisation for heart failure (hHF) in CKD patients.

2. Company Overview: Otsuka Pharmaceutical Co., Ltd.

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has R&D programs in areas including nephrology and cardiology. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does. Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan.

Product Description: JYNARQUE

JYNARQUE is a selective vasopressin V2-receptor antagonist indicated to slow kidney function decline in adults at risk of rapidly progressing ADPKD. The medication has been approved as a treatment for adults with ADPKD in Japan, the EU, Canada, South Korea, Switzerland, Hong Kong, Australia, Turkey and Taiwan. The FDA approval of JYNARQUE is supported by data from the TEMPO 3:4 (Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes) and REPRISE (Replicating Evidence of Preserved Renal Function: an Investigation of Tolvaptan Safety and Efficacy in ADPKD) clinical trials. In April 2018, the U.S. Food and Drug Administration (FDA) had approved JYNARQUE™ (tolvaptan) as the first drug treatment available to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).

Chronic Kidney Disease: Company and Product Profiles (Pipeline Therapies)

1. Company Overview: Boehringer Ingelheim

Boehringer Ingelheim is working on breakthrough therapies that improve the lives of humans and animals. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Around 52,000 employees serve more than 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing.

Product Description: Empagliflozin

Empagliflozin (BI10773) is a chemical entity that inhibits the sodium glucose co-transporter-2 (SGLT 2). BI10773 is being studied in collaboration with Boehringer Ingelheim as a treatment for chronic kidney disease. Empagliflozin is a white to yellowish, non-hygroscopic powder. It is very slightly soluble in water, sparingly soluble in methanol, slightly soluble in ethanol and acetonitrile; soluble in 50% acetonitrile/water; and practically insoluble in toluene. Each film-coated tablet of JARDIANCE contains 10 mg or 25 mg of empagliflozin (free base) and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, talc, polyethylene glycol, and yellow ferric oxide. In January 2023, The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets, which is being investigated as a potential treatment to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease (CKD), Boehringer Ingelheim and Eli Lilly and Company announced.

2. Company Overview: KBP Biosciences

KBP Biosciences is a global, clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing innovative small-molecule therapeutics for the treatment of serious cardiorenal and infectious diseases with large unmet needs. Headquartered in Princeton, NJ, KBP Biosciences principally devotes its resources to major organ protection and anti-infectives therapeutic areas. KBP Biosciences' lead product candidate, KBP-5074, is a potentially best-in-class, next-generation, non-steroidal MRA discovered and developed by KBP's scientists, is being developed globally to initially treat Stage 3b/4, or moderate-to-severe, CKD patients with uncontrolled hypertension. KBP Biosciences second product candidate, KBP-7072, a potentially best-in-class, potent, broad spectrum aminomethylcycline, is being developed as an anti-infective for Gram-positive, Gram-negative and anaerobic bacteria, including multi-drug resistant pathogens. KBP Biosciences has built a proprietary small-molecule drug discovery platform to advance its pipeline of product candidates.

Product Description: KBP-5074

KBP Biosciences' lead product candidate, KBP-5074, is a potentially best-in-class, next-generation, non-steroidal MRA discovered and developed by KBP's scientists, is being developed globally to initially treat Stage 3b/4, or moderate-to-severe, CKD patients with uncontrolled hypertension. KBP-5074 selectively binds to recombinant human MRs with much higher affinity than to recombinant human glucocorticoid, progesterone, and androgen receptors, suggesting that KBP-5074 should be effective in blocking the hypertensive and renal tissue damaging effects of aldosterone with reduced risk of pro-diabetic and adverse endocrine effects. In clinical trials conducted to-date, it has demonstrated an ability to lower blood pressure without androgenic effects such as hirsutism, obesity and gynecomastia. The drug is currently being evaluated in Phase III stage of development for the treatment of patients with Uncontrolled Hypertension and Moderate or Severe CKD.

3. Company Overview: Bayer

Bayer is a global enterprise with core competencies in the life science fields of healthcare and nutrition. We design our products and services to help people and planet thrive by supporting efforts to address the unprecedented global challenges presented by a growing and aging global population. As a global leader in health and nutrition, Bayer continue to develop the business. They create value with strategy-based resource allocation focused on profitable growth. Bayer are active in regulated and highly profitable businesses that are driven by innovation and in which Company have the objective to grow ahead of the competition.

Product Description: Runcaciguat

Runcaciguat modified release is an orally available soluble guanylate cyclase (sGC) activator. Runcaciguat works by activating proteins that helps to dilate blood vessels, including vessels in the kidneys. This can improve blood flow in kidney and may slow down the progression of kidney disease. This dilative effect can also influence the heart rate and blood pressure. Runcaciguat is under development for the treatment of non-proliferative diabetic retinopathy (NPDR), chronic kidney disease. It is administered through oral route formulated in form of tablet. It acts by targeting soluble guanylate cyclase (sGC).

4. Company Overview: Regulus Therapeutics

Regulus Therapeutics Inc. is a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs. Regulus has leveraged its oligonucleotide drug discovery and development expertise to develop a pipeline complemented by a rich intellectual property estate in the microRNA field. Regulus maintains its corporate headquarters in San Diego, CA. Regulus are focused on orphan kidney diseases where microRNA genetic drivers are implicated and there are clear unmet medical needs with an initial focus on orphan kidney diseases, including Autosomal Dominant Polycystic Kidney Disease (ADPKD).

Product Description: RGLS8429

RGLS8429 is a novel, next generation oligonucleotide for the treatment of ADPKD designed to inhibit miR-17 and to preferentially target the kidney. Administration of RGLS8429 has shown robust data in preclinical models, where clear improvements in kidney function, size, and other measures of disease severity have been demonstrated along with a superior pharmacologic profile in preclinical studies compared to Regulus' first-generation compound. Regulus announced completion of the Phase 1 SAD study in September 2022. The Phase 1 SAD study demonstrated that RGLS8429 has a favorable safety and PK profile. RGLS8429 was well-tolerated with no serious adverse events reported. Preliminary results suggest plasma exposure is dose proportional across the four doses evaluated and are similar to the PK data from the first-generation compound, RGLS4326.

Chronic Kidney Disease Analytical Perspective

In-depth Commercial Assessment: Chronic Kidney Disease Collaboration Analysis by Companies

The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition - deals values trends. The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form.

• Chronic Kidney Disease Competitive Landscape

The report comprises of comparative assessment of Companies (by therapy, development stage, and technology).

Chronic Kidney Disease Report Assessment

• Company Analysis
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions Answered

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Chronic Kidney Disease drugs?
• How many Chronic Kidney Disease drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Chronic Kidney Disease?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Chronic Kidney Disease therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Chronic Kidney Disease and their status?
• What are the key designations that have been granted to the emerging and approved drugs?

Key Players

• Boehringer Ingelheim
• Eli Lilly and Company
• Reata Pharmaceuticals
• Novo Nordisk
• KBP Biosciences
• AstraZeneca
• Allena Pharmaceuticals
• SCOHIA PHARMA
• DiaMedica Therapeutics
• CinCor Pharma
• Galapagos NV
• Sentien Biotechnologies, Inc.
• Regeneron Pharmaceuticals
• UnicoCell Biomed
• OccuRx
• Pharmicell
• Lisata Therapeutics
• Unicycive Therapeutics
• Senda Biosciences
• Sarfez Pharmaceuticals
• Rege Nephro
• Orgenesis
• GNI Group
• Algomedix
• Maze Therapeutics
• Chinook Therapeutics
• Angion Biomedica Corp
• Arch Biopartners
• Scohia Pharma
• Algernon Pharmaceuticals
• TICEBA GmbH

Key Products

• Empagliflozin
• Bardoxolone methyl
• Ziltivekimab
• KBP-5074
• AZD9977
• ALLN-346
• BI-685509
• SCO-792
• DM199
• Baxdrostat
• GLPG2737
• SBI-101
• REGN5459
• ELIXCYTE
• FT011
• Cellgram-CKD
• CLBS201
• UNI-494
• Research Program
• SZ007
• Renal progenitor cells
• MSCKD
• F351

Research programme: TRPC6 antagonist

• APOL1 Programme

Research and discovery programs: severe chronic kidney disease

• ROCK2 Inhibitor
• LSALT peptide
• SCO-116
• Repirinast
• Polycystic kidney disease (PKD)

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