Grünenthal and NovaQuest announced that they have entered into an agreement to advance the global clinical Phase III programme of Grünenthal’s asset resiniferatoxin (RTX). The investigational medicine is being developed with the aim of providing patients suffering from pain associated with osteoarthritis with a well-tolerated, non-opioid therapy option that is intended to provide long-lasting pain relief and functional improvement of the affected joints.
Osteoarthritis is a progressive condition that currently cannot be cured. The inflamed, swollen, and painful joints limit the mobility of the affected patients and may impact their quality of life significantly. RTX is a highly potent Transient Receptor Potential Vanilloid 1 (TRPV1) agonist with a well-validated mechanism of action. The Phase III trials will investigate the efficacy, safety and tolerability of RTX in patients with pain associated with osteoarthritis of the knee. The trials will start in 2022 and are designed to meet the requirements for marketing approval in the EU, the US, and Japan. NovaQuest is partnering with Grünenthal, the leading company in the therapeutic area of pain to develop RTX, a promising asset that may enter the market as soon as 2025.
Osteoarthritis (OA) can be defined as a group of distinct but overlapping diseases. They may have different etiologies, but similar biological, morphological, and clinical outcomes that affect the articular cartilage, subchondral bone, ligaments, joint capsule, synovial membrane, and periarticular muscles. OA is the most common joint disease in people aged 65 and over. Its etiology is not fully understood, although there are several related factors including female gender, genetics, metabolism, and excessive mechanical stress. The diagnosis of OA is primarily based on clinical history and physical examination. The cardinal radiographic features of OA are focal/non-uniform narrowing of the joint space in the areas subjected to the most pressure, subchondral cysts, subchondral sclerosis, and osteophytes.
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