Heart Failure Pipeline Insight

DelveInsight’s, “Heart Failure - Pipeline Insight, 2022,” report provides comprehensive insights about 90+ companies and 90+ pipeline drugs in Heart Failure pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also 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

Heart Failure Understanding

Heart Failure: Overview

Heart failure (HF) is a syndrome caused by structural and functional defects in myocardium resulting in impairment of ventricular filling or the ejection of blood. The most common cause for HF is reduced left ventricular myocardial function. Heart failure can severely decrease the functional capacity of a patient and increase mortality risk. It is imperative to diagnose and effectively treat the disease to prevent recurrent hospitalizations, improve quality of life, and enhance patient outcomes. The treatment of heart failure requires a multifaceted approach involving patient education, optimal medical regimen to improve cardiac contractility, and prevention/limitation of exacerbations. The most important consideration when categorizing heart failure is whether left ventricular ejection fraction (LVEF) is preserved or reduced (less than 50 percent). A reduced LVEF in systolic heart failure is a powerful predictor of mortality. The common symptoms of congestive heart failure include fatigue, dyspnea, swollen ankles, and exercise intolerance, or symptoms that relate to the underlying cause. Patients with heart failure present with a variety of symptoms, most of which are non-specific.

 

"Heart Failure - Pipeline Insight, 2022" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Heart Failure pipeline landscape is provided which includes the disease overview and Heart Failure treatment guidelines. The assessment part of the report embraces, in depth Heart Failure commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

  • The companies and academics are working to assess challenges and seek opportunities that could influence in Heart Failure R&D. The therapies under development are focused on novel approaches to treat/improve in Heart Failure.
  • In March 2022, Lexicon Pharmaceuticals entered into a loan facility with Oxford Finance LLC that provides up to $150 million in borrowing capacity designed primarily to support commercial preparations and the potential launch of sotagliflozin in heart failure.
  • In MAY 2021, Heartseed and Novo Nordisk entered into global collaboration and license agreement for stem cell-based therapy for heart failure. Novo Nordisk gains exclusive rights to develop, manufacture and commercialise HS-001 worldwide except in Japan. Heartseed will maintain the rights to solely develop HS-001 in Japan and Novo Nordisk has the rights to co-commercialise the product in Japan with Heartseed with 50/50 profit and cost sharing. Heartseed is eligible to receive payments totalling up to 598 million US dollars including 55 million dollars in upfront and near-term milestone payments. Heartseed is also eligible to receive tiered high single-digit to low double-digit royalties of annual net sales outside of Japan.
  • In January 2022, BenevolentAI and AstraZeneca have announced the expansion of their artificial intelligence (AI)-powered drug discovery partnership to include disease areas, systemic lupus erythematosus (SLE) and heart failure (HF). The three-year collaboration extension comprises an upfront payment, funding for research, payments on meeting development milestones and tiered royalty payments on revenues in the future.
  • In January 2021, Lexicon Pharmaceuticals received feedback from the FDA that the results of the SOLOIST and SCORED studies can support the submission of an application for regulatory approval for an indication to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent visits for heart failure in adult patients with type 2 diabetes with either worsening heart failure or additional risk factors for heart failure.
  • In March 2022, BioCardia, Inc., announced the designation of a new reimbursement code for the CardiAMP Cell Therapy procedure to transplant autologous bone marrow cells to treat heart failure from the U.S. Center for Medicare and Medicaid Services (CMS).
  • In February 2022, BioCardia, Inc. announced that the U.S. Food and Drug Administration (FDA) had granted Breakthrough Device Designation for the CardiAMP Cell Therapy System for the treatment of heart failure.  It is believed to be the first cardiac cell therapy to receive FDA Breakthrough Device status.

Heart Failure Emerging Drug Chapters

This segment of the Heart Failure report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Heart Failure Emerging Drugs

 

Tirzepatide: Eli Lilly and Company 

Tirzepatide is a once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that integrates the actions of both incretins into a single novel molecule. GIP is a hormone that may complement the effects of GLP-1. In preclinical models, GIP has been shown to decrease food intake and increase energy expenditure therefore resulting in weight reductions, and when combined with a GLP-1 receptor agonist, may result in greater effects on glucose and body weight. Tirzepatide is in phase 3 development for chronic weight management and heart failure with preserved ejection fraction (HFpEF). It is also being studied as a potential treatment for non-alcoholic steatohepatitis (NASH). Both the FDA and EMA have accepted Eli Lilly's marketing approval applications for its type 2 diabetes treatment, tirzepatide.

 

Finerenone (BAY94-8862): Bayer 

Finerenone (BAY 94-8862) is an investigational novel, non-steroidal, selective mineralocorticoid receptor antagonist (MRA) that has been shown to block the harmful effects of the overactivated mineralocorticoid receptor (MR) system. MR overactivation is a major driver of heart and kidney damage. Current steroidal MRAs on the market have proven to be effective in reducing cardiovascular mortality in patients suffering from heart failure with reduced ejection fraction (HFrEF). However, they are often underutilized due to the incidence of hyperkalemia, renal dysfunction, and anti-androgenic/ progestogenic side effects.

 

CardiAMP Cell Therapy: BioCardia

CardiAMP Cell Therapy uses a patient’s own (autologous) bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response. The CardiAMP Cell Therapy Heart Failure Trial is the first multicenter clinical trial of an autologous cell therapy to prospectively screen for cell therapeutic potency in order to improve patient outcomes.  CardiAMP Cell Therapy incorporates three proprietary elements not previously utilized in investigational cardiac cell therapy, which the company believes improves the probability of success of the treatment: a pre-procedural diagnostic for patient selection, a high target dosage of cells, and a proprietary delivery system that has been shown to be safer than other intramyocardial delivery systems and more successful for enhancing cell retention.

 

Rexlemestrocel-L (Revascor): Mesoblast 

Revascor consists of 150 million mesenchymal precursor cells (MPCs) administered by direct injection into the heart muscle in patients suffering from CHF and progressive loss of heart function. MPCs release a range of factors when triggered by specific receptor-ligand interactions within damaged tissue. Based on preclinical data, it is believed that these factors induce functional cardiac recovery by simultaneous activation of multiple pathways, including induction of endogenous vascular network formation, reduction in harmful inflammation, reduction in cardiac scarring and fibrosis, and regeneration of heart muscle through activation of tissue precursors.

 

BMS-986231: Bristol-Myers Squibb

Cimlanod (development codes CXL-1427 and BMS-986231) is an experimental drug for the treatment of acute decompensated heart failure. HNO gas (nitroxyl) is a chemical sibling of nitric oxide. Although nitric oxide and HNO appear to be closely related chemically, the physiological effects and biologic mechanisms of HNO and nitric oxide action are distinct. The biologic effects of HNO are mediated by direct post-translational modification of thiol residues in target proteins, including SERCA2a, phospholamban, the ryanodine receptor, and myofilament proteins in cardiomyocytes. In vitro, HNO increases the efficiency of calcium cycling and improves myofilament calcium sensitivity, which enhances myocardial contraction and relaxation. HNO also mediates peripheral vasodilation through endothelial soluble guanylate cyclase. HNO does not induce tachyphylaxis in peripheral vessels, unlike nitric oxide.

 

Elamipretide: Stealth BioTherapeutics

Elamipretide (MTP-131, Bendavia) is a novel tetra-peptide that targets mitochondrial dysfunction in energydepleted myocytes. Elamipretide crosses the outer membrane of the mitochondria and associates itself with cardiolipin, which is a phospholipid expressed only in the inner membrane of mitochondria. Cardiolipin has an integral role in mitochondrial stability and organization of respiratory complexes into super complexes for oxidative phosphorylation.Thus, elamipretide helps to enhance ATP synthesis in multiple organs of the body. Elamipretide has been shown to improve left ventricular ejection fraction (LVEF), LV end diastolic pressure, cardiac hypertrophy, myocardial fibrosis, and myocardial ATP synthesis in both animal models and humans.

 

FA relaxin: Bristol Myers Squibb

BMS-986259 is a next-generation version of Relaxin that is enabled with our technology and currently in Phase 1 clinical trials for ADHF. Relaxin, a peptide hormone, has been reported to reduce fibrosis in the multiple organs and to exert cardioprotective effects in preclinical studies. However, the therapeutic potential of Relaxin has been partially limited by its short half-life in humans. BMS-986259 has exhibited a prolonged half-life and therefore has the potential to enhance clinical benefit as a novel therapeutic for ADHF.

Further product details are provided in the report……..

Heart Failure: Therapeutic Assessment

This segment of the report provides insights about the different Heart Failure drugs segregated based on following parameters that define the scope of the report, such as:

 

Major Players in Heart Failure 

There are approx. 90+ key companies which are developing the therapies for Heart Failure. The companies which have their Heart Failure drug candidates in the most advanced stage, i.e. Phase III include, Eli Lilly and Company.

 

Phases

DelveInsight’s report covers around 90+ products under different phases of clinical development like

  • Late stage products (Phase III)
  • Mid-stage products (Phase II)
  • Early-stage product (Phase I) along with the details of 
  • Pre-clinical and Discovery stage candidates
  • Discontinued & Inactive candidates

 

Route of Administration

Heart Failure pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as 

  • Oral
  • Intravenous
  • Subcutaneous
  • Intracardiac
  • Intracoronary
  • Intramyocardial

 

Molecule Type

Products have been categorized under various Molecule types such as

  • Monoclonal Antibody
  • Peptides
  • Small molecule
  • Cell therapy 
  • Gene Therapy
  • Oligonucleotide

 

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Heart Failure: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Heart Failure therapeutic drugs key players involved in developing key drugs.

 

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Heart Failure drugs.

Heart Failure Report Insights

  • Heart Failure Pipeline Analysis
  • Therapeutic Assessment
  • Unmet Needs
  • Impact of Drugs

Heart Failure Report Assessment

  • Pipeline Product Profiles
  • Therapeutic Assessment
  • Pipeline Assessment
  • Inactive drugs assessment
  • Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

  • How many companies are developing Heart Failure drugs?
  • How many Heart Failure drugs are developed by each company?
  • How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Heart Failure?
  • What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Heart Failure 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 Heart Failure and their status?
  • What are the key designations that have been granted to the emerging drugs?

Introduction

Executive Summary

Heart Failure : Overview

  • Causes
  • Mechanism of Action
  • Signs and Symptoms
  • Diagnosis
  • Treatment

Pipeline Therapeutics

  • Comparative Analysis

Therapeutic Assessment

  • Assessment by Product Type
  • Assessment by Stage and Product Type
  • Assessment by Route of Administration
  • Assessment by Stage and Route of Administration
  • Assessment by Molecule Type
  • Assessment by Stage and Molecule Type

Heart Failure  – DelveInsight’s Analytical Perspective

Late Stage Products (Phase III)

  • Comparative Analysis

Tirzepatide: Eli Lilly and Company

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Mid Stage Products (Phase II)

  • Comparative Analysis

AZD-8601: AstraZeneca

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Early Stage Products (Phase I/II)

  • Comparative Analysis

Drug name: Company name

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Early Stage Products (Phase I)

  • Comparative Analysis

AZD-3427: AstraZeneca

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Preclinical and Discovery Stage Products

  • Comparative Analysis

RBM-003: Ribomic

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Inactive Products

  • Comparative Analysis

Heart Failure  Key Companies

Heart Failure  Key Products

Heart Failure - Unmet Needs

Heart Failure - Market Drivers and Barriers

Heart Failure - Future Perspectives and Conclusion

Heart Failure  Analyst Views

Heart Failure  Key Companies

Appendix

List of Table

Table 1: Total Products for Heart Failure

Table 2: Late Stage Products

Table 3: Mid Stage Products

Table 4: Early Stage Products

Table 5: Pre-clinical & Discovery Stage Products

Table 6: Assessment by Product Type

Table 7: Assessment by Stage and Product Type

Table 8: Assessment by Route of Administration

Table 9: Assessment by Stage and Route of Administration

Table 10: Assessment by Molecule Type

Table 11: Assessment by Stage and Molecule Type

Table 12: Inactive Products

List of Figures

Figure 1: Total Products for Heart Failure

Figure 2: Late Stage Products

Figure 3: Mid Stage Products

Figure 4: Early Stage Products

Figure 5: Preclinical and Discovery Stage Products

Figure 6: Assessment by Product Type

Figure 7: Assessment by Stage and Product Type

Figure 8: Assessment by Route of Administration

Figure 9: Assessment by Stage and Route of Administration

Figure 10: Assessment by Molecule Type

Figure 11: Assessment by Stage and Molecule Type

Figure 12: Inactive Products

• Eli Lilly and Company
• Bayer
• BioCardia
• Mesoblast Inc.
• Janssen Research & Development
• Pfizer
• Bristol-Myers Squibb
• Actelion Pharmaceuticals
• Tasly Pharmaceuticals
• Ionis Pharmaceuticals
• Innolife
• Imara Inc
• Bristol-Myers Squibb
• Stealth BioTherapeutics
• Bristol Myers Squibb
• Berlin Cures
• Bayer
• AstraZeneca
• Regeneron Pharmaceuticals
• GlaxoSmithKline
• SQ Innovation
• Recardio
• BIAL
• AstraZeneca
• Bristol Myers Squibb
• Imbria Pharmaceuticals
• Tenaya Therapeutics
• Ribomic

 

 

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