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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.

MTX-071 (resiniferatoxin)

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.

MTX-071 (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 MTX-071 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

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™.

MPC-06-ID (Mesoblast collaboration)

More than 7 million patients in Europe suffer from chronic low back pain associated with degenerative disc disease. Many patients still suffer from significant pain after exhausting available conservative treatment options. Together with our partner Mesoblast, we are pursuing the development of a highly innovative mesenchymal precursor cell (MPC) therapy for patients with chronic low back pain associated with degenerative disc disease who have not found effective relief from available treatment options. This programme is in Phase III clinical development.

Nociceptin/Orphanin FQ (N/OFQ) receptor agonist

Despite different treatment options being available, many patients with neuropathic pain still suffer from treatment non-response or insufficient pain relief. With our NOP receptor agonist programme, we are pursuing the development of a selective oral treatment with a unique mechanism of action for chronic peripheral neuropathic pain. This programme is based on many years of intense and ground-breaking research at Grünenthal in the field of NOP receptors, and creates a unique opportunity for a transformative first-in-class treatment.

Glucocorticoid Receptor Modulator

Glucocorticoids such as cortisone are known to be highly efficacious anti-inflammatory drugs. However, they come with several significant side effects that limit their use, particularly in chronic indications. With our GRM programme, we are pursuing the development of clinical candidates for oral treatment with broad anti-inflammatory efficacy but significantly fewer side effects than glucocorticoid-based therapies.