New Osteoarthritis Drugs Coming Down the Pipeline: A Clinical Trial Review by DelveInsight

Los Angeles, USA, May 25, 2021 (GLOBE NEWSWIRE) -- New Osteoarthritis Drugs Coming Down the Pipeline: A Clinical Trial Review by DelveInsight

Approximately 80+ key companies are developing Osteoarthritis Drugs. The companies with the Osteoarthritis drug candidates in the most advanced stage include Ampio Pharmaceuticals, Techfields Pharma, Biosplice Therapeutics, Taiwan Liposome Company and Bone Therapeutics. 

DelveInsight’s “Osteoarthritis Pipeline Insight” report provides comprehensive insights about 80+ companies and 80+ pipeline drugs in the Osteoarthritis pipeline landscapes. It comprises Osteoarthritis pipeline drug profiles, including clinical and non-clinical stage products. It also includes the Osteoarthritis therapeutics assessment by product type, stage, route of administration, and molecule type and further highlights the inactive Osteoarthritis pipeline products.  

Some of the key takeaways of the Osteoarthritis Pipeline Report  

• 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 April 2021, Biosplice Therapeutics announced the execution of a licensing agreement that grants Samil the right to develop and exclusively commercialize lorecivivint (SM04690) for the treatment of knee osteoarthritis (“OA”) in the Republic of Korea. 
• In April 2021, Eupraxia Pharmaceuticals announced that it has entered into an agreement (the "CTO Agreement") with NBCD A/S ("NBCD") to conduct Eupraxia's EP-104IAR Phase 2 clinical trial that will initiate later this year.
• In October 2020, Merck KGaA entered into an out-licensing agreement with Novartis for the development of an osteoarthritis clinical-stage programme. Under the terms of the deal, Merck will out-license M6495 to Novartis for further evaluation in osteoarthritis patients.
• In September 2020, Sorrento Therapeutics released positive Phase 1b trial data (clinicaltrials.gov NCT03542838) of resiniferatoxin (RTX) in the reduction of OsteoArthritis (OA) knee pain.
• X0002 is a new anti-inflammatory drug that acts as an inhibitor of Cyclooxygenase. It is currently in the Phase III stage of development for Osteoarthritis and is being developed by Techfields Pharma. 
• In July 2020, the FDA granted the Fast Track Designation to X0002 for Knee Osteoarthritis and the low back. 

Get an overview of pipeline landscape @ Osteoarthritis Clinical Trials Analysis 

Osteoarthritis is a type of arthritis caused by inflammation, breakdown, and eventual loss of cartilage in the joints. Osteoarthritis treatment can be broadly classified into reducing modifiable risk factors, intraarticular therapy, physical modalities, alternative therapies, and surgical treatments. 

Osteoarthritis Emerging Drugs

• X0002: Techfields Pharma

Research and Development

Phase III 

NCT03081806: Techfields Pharma, in April 2021, initiated “A Phase 3, Multicenter, 22-Week, Double-Blind and 30-Week Open Label Study to Evaluate the Efficacy and Safety of X0002 Spray in Relief of the Signs and Symptoms of Subjects With Osteoarthritis of the Knee”. This is a Phase 3, Multicenter, 22-Week, double-blind, and 30-Week open-label Study to Evaluate the Efficacy and Safety of X0002 Spray in relief of the signs and symptoms of subjects with Osteoarthritis of the Knee. 

Results 

Techfields announced excellent results from the Phase II trial of X0002 in China. X0002 is a new anti-inflammatory drug that demonstrated an excellent safety profile and efficacy.

• Ampion: Ampio Pharmaceuticals

Research and Development

Phase III 

NCT03988023: Ampio Pharmaceuticals, in June 2019, initiated “ A Randomized, Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of an Intra-Articular Injection of Ampion in Adults With Pain Due to Severe Osteoarthritis of the Knee”. The purpose of this study is to confirm the safety and efficacy of Ampion for the treatment of pain and function in patients with severe osteoarthritis of the knee. This study is a randomized, double-blind, single-dose design. This study is conducted on male and female patients between ≥40 and 85 years of age with severe osteoarthritis of the knee. Approximately 1034 patients with severe osteoarthritis of the knee randomized 1 to 1 treatment group (1:1) will receive a single intra- injection of 4 millilitre (mL) of Ampion or saline.

Results

Ampio Pharmaceuticals has reported that the Phase 3 clinical trial of Ampion met its primary endpoint with 71% of Ampion treated patients meeting the OMERACT-OARSI responder criteria, which exceeds the physician reported threshold of 30% for a meaningful treatment in severe osteoarthritis of the knee (p < 0.001).

For further information, refer to the detailed report @ Osteoarthritis Pipeline Therapeutics 

Scope of Osteoarthritis Pipeline Drug Insight    

• Coverage: Global 
• Major Players: 80+  Key Players
• Prominent Players: Amplicore Pharma, Peptinov, Novartis, Galapagos, AKL Research and Development, Ampio Pharmaceuticals, Techfields Pharma, Bone Therapeutics, Taiwan Liposome Company and many others.   
• Key Drugs Profiles: 80+ Products
• Phases:  

• Osteoarthritis Therapies Late-stage (Phase III)  
• Osteoarthritis Therapies Mid-stage (Phase II)
• Osteoarthritis Therapies Early-stage (Phase I) 
• Osteoarthritis Pre-clinical stage and Discovery candidates     
• Discontinued and Inactive candidates 

• Mechanism of Action:

• NF-E2-related factor 2 modulators; NF-kappa B kinase modulators
• Cyclooxygenase inhibitors
• ADAMTS5 protein inhibitors
• Cytokine inhibitors
• Interleukin 6 inhibitors 
• Molecule Types:   
• Small Molecule 
• Gene Therapy 
• Stem Cell Therapy 

• Route of Administration:

• Intravenous  
• Inhalation 
• Subcutaneous 
• Oral 

• Product Types:

• Monotherapy
• Combination
• Mono/Combination 

Key Questions regarding Current Osteoarthritis Treatment Landscape and Emerging Therapies Answered in the Pipeline Report  

• What are the current options for Osteoarthritis treatment?
• How many companies are developing therapies for the treatment of Osteoarthritis? 
• How many are Osteoarthritis emerging therapies in the early-stage, mid-stage, and late development stages to treat Osteoarthritis? 
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, and significant licensing activities that will impact the Osteoarthritis market? 
• Which are the dormant and discontinued products and the reasons for the same?
• What is the unmet need for current therapies for the treatment of Osteoarthritis?  
• What are the current novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing Osteoarthritis therapies? 
• What are the critical designations that have been granted for the emerging therapies for Osteoarthritis? 
• How many patents are granted and pending for the emerging therapies to treat Osteoarthritis?   

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