Summary

KEY INSIGHTS
Sprifermin (AS-902330) is a recombinant version of human fibroblast growth factor 18 (FGF18). Sprifermin acts as a strong agonist for FGFR2 and FGFR3 receptors. It is administered through injections directly into the joint, typically every 6 to 12 months. Notably, sprifermin is the first recombinant form of FGF18 shown to promote cartilage growth in a controlled clinical trial, positioning it at the forefront of next-generation regenerative therapies with the potential to alter the disease progression in osteoarthritis.
Initially developed by Merck KGaA, sprifermin’s potential has been recognized for its application in osteoarthritis treatments, especially where conventional osteoarthritis medication may not suffice. In June 2022, TrialSpark announced the establishment of High Line Bio following its acquisition of global rights to sprifermin from Merck KGaA, Darmstadt, Germany. TrialSpark, founded in 2016 and headquartered in New York, is a technology-driven company specializing in clinical research and drug development.
TrialSpark aims to streamline and accelerate the clinical trial process, minimizing manual tasks that often cause delays. In addition to optimizing clinical trials, TrialSpark also acquires clinical-stage drugs from pharmaceutical and biotech companies, focusing on their rapid development to bring innovative treatments to market more quickly.
MARKET POTENTIAL AND POSITIONING
Sprifermin (AS-902330) is currently being developed as a treatment for knee osteoarthritis. Originally under development by Merck, sprifermin is a recombinant form of FGF18 and acts as a potent agonist for FGFR2 and FGFR3 receptors. The drug is undergoing Phase II clinical trials to assess its effectiveness in patients with osteoarthritis.
Sprifermin represents a potentially first-in-class disease-modifying therapy that promotes cartilage growth, directly targeting a key factor in the progression of osteoarthritis—a degenerative joint condition characterized by cartilage loss. This novel approach addresses a significant unmet medical need in musculoskeletal health, as osteoarthritis remains one of the leading causes of disability and reduced quality of life worldwide, affecting over 230 million people.
Currently, there are no approved therapies that modify the underlying disease process of osteoarthritis, positioning sprifermin as a unique and potentially transformative treatment option in this space.
REGIONAL ANALYSIS
Inkwood Research offers an analysis of seven key markets:
• United States
• Germany
• France
• United Kingdom
• Italy
• Spain
• Japan
o The most commonly prescribed medications for osteoarthritis in Japan include nonsteroidal anti-inflammatory drugs (NSAIDs) and analgesics to relieve pain and reduce inflammation. Intra-articular corticosteroid injections are also used for more severe cases to provide temporary relief from pain and swelling.
o The Japanese healthcare system is well-positioned to adopt new technologies and therapies, given its robust infrastructure and commitment to medical innovation. There is an increasing emphasis on research and development to discover novel treatments that can more effectively manage and potentially reverse osteoarthritis.
o As a result, Japan is becoming an important market for clinical trials and the development of new therapeutic approaches, including regenerative medicine.

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Table of Contents

TABLE OF CONTENTS
1. INTRODUCTION TO THE REPORT
2. SPRIFERMIN OVERVIEW
2.1. PRODUCT DETAIL
2.2. CLINICAL DEVELOPMENT
2.2.1. CLINICAL STUDIES
2.2.2. CLINICAL TRIALS INFORMATION
2.2.3. SAFETY AND EFFICACY
2.3. OTHER DEVELOPMENTAL ACTIVITIES
2.4. PRODUCT PROFILE
3. COMPETITIVE LANDSCAPE
3.1. MARKETED THERAPIES
3.2. LATE-STAGE EMERGING THERAPIES
4. SPRIFERMIN MARKET ASSESSMENT
4.1. MARKET OUTLOOK OF SPRIFERMIN IN OSTEOARTHRITIS
5. 7 MAJOR MARKET’S ANALYSIS
5.1. MARKET SIZE OF SPRIFERMIN IN THE 7 MAJOR MARKETS FOR OSTEOARTHRITIS
5.2. 7 COUNTRY ANALYSIS
5.2.1. MARKET SIZE OF SPRIFERMIN IN UNITED STATES FOR OSTEOARTHRITIS
5.2.2. MARKET SIZE OF SPRIFERMIN IN GERMANY FOR OSTEOARTHRITIS
5.2.3. MARKET SIZE OF SPRIFERMIN IN FRANCE FOR OSTEOARTHRITIS
5.2.4. MARKET SIZE OF SPRIFERMIN IN ITALY FOR OSTEOARTHRITIS
5.2.5. MARKET SIZE OF SPRIFERMIN IN SPAIN FOR OSTEOARTHRITIS
5.2.6. MARKET SIZE OF SPRIFERMIN IN UNITED KINGDOM FOR OSTEOARTHRITIS
5.2.7. MARKET SIZE OF SPRIFERMIN IN JAPAN FOR OSTEOARTHRITIS
6. SWOT ANALYSIS
7. ANALYST PERSPECTIVE