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-Medivir

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-Samumed

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.