Osteoarthritis has historically lagged behind rheumatoid arthritis in terms of research and drug development. Given the number of people who have or will develop OA (due in part to our increasing elderly population), there is a significant unmet need for new drug treatments.
Clinical research for OA has traditionally focused on improving pain medications to make them safer, non-addictive, more effective or longer acting. However, disease-modifying osteoarthritis drugs (DMOADs) are urgently needed to not only alleviate pain and improve function but also delay the structural progression of the disease. There are drugs that are being tested now for OA and some will be reviewed for FDA approval in the future. Many are still in clinical trials. That means researchers are still testing them to see if they work well to control OA symptoms and affect OA progression; to make sure they are safe enough for you to take; and don’t have side effects that would outweigh the possible health benefits of the drug.
Osteoarthritis Drugs in Phase 2 Clinical Trials (as of November 2017)
- GSK3196165, an antibody directed against GM-CSF (granulocyte-macrophage colony-stimulating factor)
- SM04690, a Wnt pathway inhibitor, intra-articular injection
- JTA-004, an intra-articular injection
- Botox®, Botulinum toxin A, intra-articular injection
- ZYN002, CBD gel (synthetic transdermal cannabidiol)
- MIV-711, an oral cathepsin K inhibitor
Osteoarthritis Drugs in Phase 3 Clinical Trials (as of November 2017)
- Tanezumab, an antibody directed against NGF (nerve growth factor)
- XS-02, oral Disodium Zoledronate Tetrahydrate
- Fasinumab, an antibody directed against NGF (nerve growth factor)
- Invossa™, a cell and gene therapy, intra-articular injection
- Sprifermin, FGF-18 (fbroblast growth factor 18), intra-articular injection
- Ampion™, a low molecular weight fraction of human serum albumin (HSA), intra-articular injection
Additional clinical trials may be available. For a complete list of clinical trials, including eligibility information from the individual sponsors of the clinical trials, go to: www.ClinicalTrials.gov.
DMOADS: Disease Modifying Osteoarthritis Drug
In recent years, emerging regenerative therapies for OA have gained much attention as they have shown potential to go beyond temporary symptom relief alone and promote cartilage repair and regeneration within a joint. These potential DMOADs that are being investigated in clinical trials target unique disease mechanisms to try and achieve the same therapeutic goal: the preservation or restoration of articular cartilage. The drugs and biologics below are currently in different stages of clinical trials and have not yet been approved by the FDA.
INVOSSA™-Tissue Gene/Kolon (Biologic)
INVOSSA™ is a cell and gene therapy option being investigated for the treatment of osteoarthritis that contains a mixture of non-transformed chondrocytes with chondrocytes which were transduced with a retroviral vector to overexpress TGF-1. INVOSSA™ has been recently approved in South Korea and is currently being tested in phase 3 clinical trials in the US.
MIV-711 is a highly selective inhibitor of cathepsin K, a protein that breaks down collagen and plays an important role in the structural integrity of both bone and cartilage. Medivir’s research has shown that inhibition of cathepsin K can reduce the rate of joint destruction in preclinical models of osteoarthritis. MIV-711 is in phase 2 clinical trials.
SM04690 is being developed as an intra-articular (IA) knee injection to target cellular mechanisms that may promote the regeneration of cartilage cells in the joint. SM04690 inhibits the function of a key pathway (Wnt) that plays a pivotal role in the maturation of a type of progenitor cells that reside in the joint and have the potential to become chondrocytes, a key component in the formation of cartilage. SM04690 is currently being tested in phase 2 clinical trials.
Sprifermin-Merck KgA (Biologic)
Sprifermin is in clinical development to investigate its potential as a treatment for osteoarthritis (OA) in the knee. It is a truncated recombinant human FGF-18 protein thought to induce chondrocyte proliferation and increased extra-cellular matrix (ECM) production, with the potential of promoting cartilage growth and repair. Sprifermin is currently in Phase 3 studies.