Our lead projects
To move closer to our vision of a world free of pain, we are currently pursuing a range of programmes across different modalities, targets and mechanisms of action. Here are some selected highlights from our development pipeline.
Osteoarthritis (OA) is a progressive condition that currently cannot be cured. The inflamed, swollen and painful joints lead to limitation on mobility of the affected patients and may impact their quality of life significantly. Millions of OA-patients currently receive intra-articular corticosteroids or need to undergo knee replacement surgery as last remaining treatment option.
RTX (resiniferatoxin) is an investigational medicine for the intra-articular treatment of pain associated with osteoarthritis of the knee. The highly potent TRPV1 agonist currently concludes Phase II of clinical development. Its mechanism of action is well validated and initial data show a long-lasting and significant analgesic effect and functional improvements compared to placebo (saline injection), as well as a favourable safety profile.
We are currently preparing two pivotal Phase III studies to investigate the efficacy, safety and tolerability of RTX in patients with pain associated with osteoarthritis of the knee. The studies will start in 2021 and they are part of a global development programme aimed at meeting the requirements for approval in the EU, the US, Japan and China.
Qutenza™ is a cutaneous patch (capsaicin 179 mg/8%) that is approved for the treatment of peripheral neuropathic pain in Europe. In the US, Qutenza™ is approved for the treatment of neuropathic pain associated with postherpetic neuralgia and for the treatment of neuropathic pain associated with diabetic peripheral neuropathy of the feet in adults.
Currently, we are preparing a Phase III trial to study the efficacy, safety and tolerability of Qutenza™ in post-surgical neuropathic pain (PSNP) with the goal to expand the current U.S. product label. First patients are expected to be enrolled in the third quarter of 2021 with trial completion expected in 2024. In addition we continue to consider additional lifecycle management ideas to further demonstrate the benefits of Qutenza™.