Summary

KEY INSIGHTS
Lorecivivint (SM04690) is a small-molecule inhibitor targeting the Wnt pathway, delivered through intra-articular injection, and is being explored as a potential disease-modifying osteoarthritis drug (DMOAD). Preclinical studies with vehicle-controlled models suggest that lorecivivint may act through a dual mechanism, providing three key benefits for joint health: promoting cartilage regeneration, slowing cartilage degradation, and reducing inflammation. These effects are increasingly important as there is a rising demand for osteoarthritis medication that not only relieves symptoms but also alters the course of the disease.
By inhibiting the nuclear kinases CLK2 and DYRK1A, lorecivivint affects the Wnt pathway, chondrocytes, and inflammatory processes. This dual action indicates that lorecivivint may not only modify osteoarthritis progression by enhancing chondrocyte differentiation and function but also alleviate symptoms through its anti-inflammatory effects. Such advancements could be pivotal for osteoarthritis patients, particularly those with advanced osteoarthritis, who require more effective therapy for osteoarthritis beyond traditional options.
The drug is being developed by Biosplice Therapeutics Inc, a California-based biopharmaceutical company founded in 2008 by Osman Kibar. Biosplice Therapeutics specializes in creating small-molecule therapeutics for various conditions, including osteoarthritis, oncology, and neurology. The company’s innovative platform utilizes alternative pre-mRNA splicing to identify new targets and biological processes that can lead to the development of curative therapies. Their treatments focus on the CLK/DYRK kinase family, which regulates the selection of RNA splice sites unique to certain tissues and diseases. In addition to their work on osteoarthritis, Biosplice Therapeutics is advancing clinical trials in oncology, aiming to inhibit pan-CLK and DYRK kinases.
MARKET POTENTIAL AND POSITIONING
Lorecivivint (LOR), an investigational intra-articular therapy developed by Biosplice Therapeutics, is emerging as a potential breakthrough in knee osteoarthritis (OA) treatment. By targeting the CLK2 and DYRK1A pathways to modulate Wnt signaling, lorecivivint offers a dual mechanism of action that not only alleviates symptoms but also holds promise as a disease-modifying therapy. This innovative approach distinguishes lorecivivint from existing treatments, generating significant anticipation in the OA market.
Currently undergoing Phase III clinical trials, lorecivivint has shown promising results in recent studies OA-07, OA-10, and OA-11. Data from these trials indicate its efficacy in improving both joint structure and patient-reported outcomes, such as pain and function. Notably, the OA-07 study revealed statistically significant improvements in joint structure, pain reduction, and functional enhancement, particularly in patients with early joint damage.
REGIONAL ANALYSIS
Inkwood Research offers an analysis of seven key markets:
• United States
• Germany
• France
• United Kingdom
• Italy
• Spain
o Osteoarthritis (OA) is a major public health issue in Spain, with its prevalence rising, especially among the aging population. A significant portion of the Spanish population is affected by osteoarthritis, with knee and hip osteoarthritis being the most prevalent forms.
o Women, particularly post-menopause, are more commonly affected by osteoarthritis (OA) than men, reflecting global trends. In Spain, the rising prevalence of OA is driven by an aging population, increased obesity rates, and a higher prevalence of sedentary lifestyles. These factors, along with the chronic nature of osteoarthritis, are placing an escalating burden on Spain’s healthcare system. This situation is leading to a growing demand for effective treatments and interventions that can manage symptoms and enhance the quality of life for those affected.
• Japan

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Table of Contents

TABLE OF CONTENTS
1. INTRODUCTION TO THE REPORT
2. LORECIVIVINT 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. LORECIVIVINT MARKET ASSESSMENT
4.1. MARKET OUTLOOK OF LORECIVIVINT IN OSTEOARTHRITIS
5. 7 MAJOR MARKET’S ANALYSIS
5.1. MARKET SIZE OF LORECIVIVINT IN THE 7 MAJOR MARKETS FOR OSTEOARTHRITIS
5.2. 7 COUNTRY ANALYSIS
5.2.1. MARKET SIZE OF LORECIVIVINT IN UNITED STATES FOR OSTEOARTHRITIS
5.2.2. MARKET SIZE OF LORECIVIVINT IN GERMANY FOR OSTEOARTHRITIS
5.2.3. MARKET SIZE OF LORECIVIVINT IN FRANCE FOR OSTEOARTHRITIS
5.2.4. MARKET SIZE OF LORECIVIVINT IN ITALY FOR OSTEOARTHRITIS
5.2.5. MARKET SIZE OF LORECIVIVINT IN SPAIN FOR OSTEOARTHRITIS
5.2.6. MARKET SIZE OF LORECIVIVINT IN UNITED KINGDOM FOR OSTEOARTHRITIS
5.2.7. MARKET SIZE OF LORECIVIVINT IN JAPAN FOR OSTEOARTHRITIS
6. SWOT ANALYSIS
7. ANALYST PERSPECTIVE