Sprifermin: a recombinant human fibroblast growth factor 18 for the treatment of knee osteoarthritis

ABSTRACT

Introduction

Osteoarthritis (OA) is a serious and incurable disease leading the disability. Surgical treatment is the last but not necessarily the best approach for patients with high risks and costs. However, there are no disease-modifying OA drugs (DMOADs) developed for the disease so far, leaving a huge unmet need for drug treatments. Sprifermin is a recombinant human fibroblast growth factor 18 (rhFGF18) and has been confirmed to have anabolic effects on articular cartilage, which makes it a promising DMOAD.

Areas covered

The content of this review includes overview of the market, discovery and development, molecular mechanism, preclinical studies, clinical efficacy, safety, and tolerability of sprifermin. It examines the potential of sprifermin as a disease modifying drug for the treatment of knee OA.

Expert opinion

Sprifermin could be one of the most promising DMOADs, especially for cartilage phenotype. Current studies show good tolerability and no safety concerns. Well-designed phase 3 clinical trials are required to examine its effects on symptoms and cartilage loss in knee OA.

KEYWORDS:

• Sprifermin
• FGF18
• cartilage
• knee osteoarthritis
• disease-modifying osteoarthritis drug

Drug summary

Table

ARTICLE HIGHLIGHTS

• Osteoarthritis (OA) is a serious and incurable disease, which is a leading cause of disability and a high burden of socioeconomic cost among older people.

• A potential disease-modifying OA drug (DMOAD) would be able to modify structural damage, as well as alleviate worsening of symptoms.

• Degradation of cartilage is one of the most important pathologies of OA.

• Sprifermin, as a recombinant human fibroblast growth factor 18 (rhFGF18), could be one of the most promising DMOADs, especially for cartilage phenotype.

• Intra-articular injection with sprifermin in Phase 1 and phase 2 studies has demonstrated the efficacy on increasing cartilage thickness with favorable safety, though no significant effect has been found on symptoms yet.

• Well-designed phase 3 clinical trials are expected to replicate the findings of sprifermin on structural modification, and to confirm its therapeutic effects on knee symptoms in the future.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose

Declaration of interest

C Ding receives consulting fees from BioBone. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Additional information

Funding

This work was supported by the National Natural Science Foundation of China (81773532, 81974342, 8210120058) and GuangDong Basic and Applied Basic Research Foundation (2019A1515111169).