Osteoarthritis Pipeline Insight

DelveInsight’s, “Osteoarthritis - Pipeline Insight, 2022,” report provides comprehensive insights about 80+ companies and 80+ pipeline drugs in Osteoarthritis 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

Osteoarthritis Understanding

Osteoarthritis: Overview

Osteoarthritis, also known as degenerative joint disease (DJD), is the most common form of arthritis. Osteoarthritis is more likely to develop as people age. The changes in osteoarthritis usually occur slowly over many years, though there are occasional exceptions. Osteoarthritis affecting millions of people lie worldwide. It occurs when the protective cartilage that cushions the ends of the bones wears down over time. Although osteoarthritis can damage any joint, the disorder most commonly affects joints in your hands, knees, hips and spine. Approximately 80% of older adults have osteoarthritis, ages 55 years and older, have evidence of osteoarthritis. Approximately 60% experience symptoms and symptoms worsen over time like Pain, Stiffness, Tenderness, Loss of flexibility, Grating sensation, Bone spurs and Swelling. Eventually, if the cartilage wears down completely, bone will rub on bone. Osteoarthritis has often been referred to as a wear and tear disease. But besides the breakdown of cartilage, osteoarthritis affects the entire joint. It causes changes in the bone and deterioration of the connective tissues that hold the joint together and attach muscle to bone. It also causes inflammation of the joint lining.

 

"Osteoarthritis - Pipeline Insight, 2022" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Osteoarthritis pipeline landscape is provided which includes the disease overview and Osteoarthritis treatment guidelines. The assessment part of the report embraces, in depth Osteoarthritis 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, Osteoarthritis 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 Osteoarthritis R&D. The therapies under development are focused on novel approaches to treat/improve Osteoarthritis. 

  • Prominent companies such as Amplicore Pharma, Peptinov, Novartis, Galapagos, AKL Research and Development, Ampio Pharmaceuticals, Techfields Pharma, Bone Therapeutics and others are developing potential drug candidates to boost the Osteoarthritis treatment scenario.
  • In April 2021, Ampio Pharmaceuticals announced that it had received a positive response from the U.S. Food and Drug Administration (FDA) on its plans for its AP-013 Phase III trial for the intra-articular injection of Ampion, its novel anti-inflammatory, for patients suffering from severe osteoarthritis of the knee (OAK).
  • In October 2020, Merck KGaA entered into an out-licensing agreement with Novartis for the development of of M6495, an anti-ADAMTS5 Nanobody for the potential treatment of osteoarthritis (OA). Anti-ADAMTS5 Nanobody program is Phase II-ready with novel MoA which could protect against cartilage damage and reduce joint pain.

Osteoarthritis Drug Chapters

This segment of the Osteoarthritis 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.

 

Osteoarthritis Emerging Drugs

 

Ampion: Ampion Pharmaceuticals

Ampion is a novel biologic drug containing a blood-derived cyclized peptide and small molecules that target multiple pathways in the innate immune response characteristic of inflammatory disease. Ampio is a non-steroidal anti-inflammatory drug that appears to have a significant role in the inflammatory conditions, including osteoarthritis, respiratory illness, and other inflammatory diseases. A Phase III clinical trial, AP-013 study was designed to confirm the efficacy observed in the first pivotal trial, AP-003-A, and was powered to detect treatment differences between Ampion and saline control. The AP-013 study was initiated in June 2019 and was ongoing when the COVID-19 outbreak occurred, which resulted in a large amount of missing data due to the pandemic. In March 2021, positive data from the modified Intent-to-Treat (mITT) population in the Company's AP-013 study, a Phase III clinical trial of the company's lead candidate, Ampion™, in patients suffering from severe osteoarthritis of the knee (OAK).

 

Lorecivivint: Biosplice Therapeutics

Lorecivivint (SM04690) is a small‐molecule CDC-like kinase 2 (CLK2) and dual-specificity tyrosine phosphorylation-regulated kinase 1A (DYRK1A) currently in development as a potential DMOAD for the treatment of knee OA. Company is conducting two large phase III clinical trials. Company hopes to demonstrate reduction in knee osteoarthritis pain with a single injection over the course of 6 months and 12 months, with follow-up beyond a year. Biosplice is also exploring the impact lorecivivint plays on inflammation, function, and cartilage protective effects through patient reported outcomes and structural endpoints.

 

X0002: Techfields Pharma

X0002 is a new anti-inflammatory drug that acts as an inhibitor of Cyclooxygenase. The FDA has granted the Fast Track Designation to X0002 for Knee Osteoarthritis and the low back. A Phase III, multicenter, double-blind, open-label, 22-Week and 30-week study is ongoing to evaluate the efficacy, safety, and pharmacokinetics of X0002 spray in relief of the pain for subjects with Osteoarthritis of the knee. 

 

TLC599: Taiwan Liposomal Company

TLC599 is proprietary Bio Seizer formulation of dexamethasone sodium phosphate (DSP). BioSeizer formulation of dexamethasone sodium phosphate (DSP) is designed to provide sustained pain management for up to 24 weeks. In a Phase II trial, a single intra-articular injection of TLC599 resulted in statistically significant and clinically meaningful improvement in pain relief as compared to placebo from Day 3 all the way through the end of the study at 24 weeks in both the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Visual Analog Scale (VAS) scores.

 

MIV-711: Medivir AB

MIV-711 is a Cathepsin K inhibitor, that breakdown the collagen, a protein that plays an important role in the structural integrity of both bone and cartilage. MIV-711 has already been received Fast Track designation as a disease-modifying agent for osteoarthritis from FDA. Phase II data provides good support for further clinical development of MIV-711 as a disease-modifying treatment for osteoarthritis. In preclinical studies, MIV-711 has demonstrated that inhibition of cathepsin K can reduce the rate of joint destruction of osteoarthritis, and these findings have now been supported in clinical studies.

Osteoarthritis: Therapeutic Assessment

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

Major Players in Osteoarthritis

There are approx. 80+ key companies which are developing the therapies Osteoarthritis. The companies which have their Osteoarthritis drug candidates in the most advanced stage, i.e. phase III include, Ampion Pharmaceuticals

 

Phases

DelveInsight’s report covers around 80+ 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

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

  • Intrathecal
  • Intravenous
  • Oral
  • Oral/Intravenous
  • Parenteral
  • Subcutaneous
  • Subcutaneous/Intramuscular 

 

Molecule Type

Products have been categorized under various Molecule types such as

  • Neuropeptides
  • Oligonucleotides
  • Small Molecule
  • Stem Cells

 

Product Type

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

Osteoarthritis: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Osteoarthritis 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 Osteoarthritis drugs.

Osteoarthritis Report Insights

  • Osteoarthritis Pipeline Analysis
  • Therapeutic Assessment
  • Unmet Needs
  • Impact of Drugs

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

Introduction

Executive Summary

Osteoarthritis: Overview

  • Causes
  • Mechanism of Action
  • Signs and Symptoms
  • Diagnosis
  • Disease Management

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

Osteoarthritis – DelveInsight’s Analytical Perspective

Late Stage Products (Phase III)

  • Comparative Analysis

Ampion: Ampion Pharmaceuticals

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Mid Stage Products (Phase II)

  • Comparative Analysis

LNA043: Novartis

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Early Stage Products (Phase I)

  • Comparative Analysis

M6495: Merck KGaA

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Inactive Products

  • Comparative Analysis

Osteoarthritis Key Companies

Osteoarthritis Key Products

Osteoarthritis- Unmet Needs

Osteoarthritis- Market Drivers and Barriers

Osteoarthritis- Future Perspectives and Conclusion

Osteoarthritis- Analyst Views

Osteoarthritis Key Companies

Appendix

List of Table

Table 1: Total Products for Osteoarthritis

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 Osteoarthritis

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   

• Techfields Pharma
• K-STEMCELL
• Taiwan Liposomal Company
• Ampio Pharmaceuticals
• Biosplice Therapeutics
• Symic Bio
• Gwo Xi Stem Cell Applied Technology
• UnicoCell Biomed
• Shionogi
• Eli Lilly and Company
• Xalud Therapeutics   
• ICM Biotech
• Centrexion Therapeutics
• AstraZeneca
• Merck KGaA
• Novartis
• Antibe Therapeutics
• Bioventus
• PMG Pharm
• Meluha Life Sciences SDN BHD
• Meluha Life Sciences SDN BHD
• Anika Therapeutics
• Meiji Seika Pharma
• Peptinov
• OrthoTrophix
• CartilaGen
• MiMedx Group
• Medivir
• Orient Europharma Co
• HSRx Biopharmaceutical

 

 

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