Ampion Emerging Drug Insight and Market Forecast - 2032

“Ampion Emerging Drug Insight and Market Forecast - 2032” report provides comprehensive insights about ampion for knee osteoarthritis (OA) in the seven major markets. A detailed picture of the ampion for knee osteoarthritis in the 7MM, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan, for the study period 2019 -2032 is provided in this report along with a detailed description of the ampion for knee osteoarthritis. The report provides insights about mechanism of action, dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the ampion market forecast analysis for knee osteoarthritis in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in knee osteoarthritis.

Drug Summary

Ampion is an investigational drug being developed by Ampio Pharmaceuticals. It is an intra-articular injection to treat the signs and symptoms of severe knee OA, which continues to be a growing epidemic in the United States and other countries worldwide.

Ampion regulates key components of the immune response connected to pain, inflammation, and joint damage in OA. In vitro studies show that Ampion reduces the production of the cytokines responsible for inflammation (TNFα, IL-1β, IL-6, IL-12) by regulating the genetic, transcriptional pathways (NFκB, STAT) responsible for the overproduction of these cytokines while activating anti-inflammatory proteins responsible for tissue growth and healing. This mechanism of action has an overall clinical effect that has been shown to relieve pain and improve function in the knee for patients in clinical trials. Ampion has been shown to uniquely reduce inflammation along multiple pathways, unlike other anti-inflammatory therapies that target only one mechanism. Ampion achieves its biological effect by targeting the overproduction of cytokines, which is common in multiple inflammatory diseases like OA, respiratory disease, and other inflammatory conditions. It has been shown to uniquely reduce inflammation along multiple pathways, unlike other anti-inflammatory therapies that target only one mechanism.

Ampio's osteoarthritis (OA) program looks at the safety and efficacy of Ampion injection in the joint. The FDA has accepted the results of one pivotal Phase III trial of Ampion for knee OA. A second Phase III pivotal trial to support efficacy for the Ampion marketing application is being conducted currently under an FDA Special Protocol Assessment (SPA). Treatment in other joints was explored with one complete Phase I (NCT02762760) trial for OA of the hand.

According to the company, the second Phase III trial in knee OA was paused in early 2020 due to the COVID-19 pandemic. Ampio has recently proposed to the FDA to close that study and use the data gathered in both Phase III trials to support a commercial Biologics Licensing Application (“BLA”). In March 2021, Ampio submitted a proposal to the FDA to use existing data only in submitting its application for a commercial BLA for Ampion intra-articular injection in knee OA. A factor supporting this proposal was the large block of historical data from previous clinical trials. The current study remains blinded until Ampio receives written confirmation from the FDA that the proposal to use only existing data has been accepted and the existing SPA remains in effect.

Scope of the Report

The report provides insights into:

• A comprehensive product overview including the ampion description, mechanism of action, dosage and administration, research and development activities in knee osteoarthritis.
• Elaborated details on ampion regulatory milestones and other development activities have been provided in this report.
• The report also highlights the ampion research and development activities in knee osteoarthritis across the United States, Europe and Japan.
• The report also covers the patents information with expiry timeline around ampion.
• The report contains forecasted sales of ampion for knee osteoarthritis till 2032.
• Comprehensive coverage of the late-stage emerging therapies for knee osteoarthritis.
• The report also features the SWOT analysis with analyst views for ampion in knee osteoarthritis.

Methodology

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by a team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

Ampion Analytical Perspective

In-depth Ampion Market Assessment

This report provides a detailed market assessment of ampion for knee osteoarthritis in the seven major markets, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. This segment of the report provides forecasted sales data from 2023 to 2032.

Ampion Clinical Assessment

The report provides the clinical trials information of ampion for knee osteoarthritis covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights

• In the coming years, the market scenario for knee osteoarthritis is set to change due to the extensive research and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence ampion dominance.
• Other emerging products for knee osteoarthritis are expected to give tough market competition to ampion and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of ampion in knee osteoarthritis.
• Our in-depth analysis of the forecasted sales data of ampion from 2023 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the ampion in knee osteoarthritis.

Key Questions Answered

• What is the product type, route of administration and mechanism of action of ampion?
• What is the clinical trial status of the study related to ampion in knee osteoarthritis and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the ampion development?
• What are the key designations that have been granted to ampion for knee osteoarthritis?
• What is the forecasted market scenario of ampion for knee osteoarthritis?
• What are the forecasted sales of ampion in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan?
• What are the other emerging products available and how are these giving competition to ampion for knee osteoarthritis?
• Which are the late-stage emerging therapies under development for the treatment of knee osteoarthritis?