Pharma Focus Europe

Grünenthal starts Phase III trials for resiniferatoxin in osteoarthritis-related pain

Friday, August 19, 2022

Grünenthal announced today that the company has enrolled the first patient in its global clinical Phase III programme for resiniferatoxin (RTX).

RTX is a highly potent Transient Receptor Potential Vanilloid 1 (TRPV1) agonist, with a well-validated mechanism of action. The discovery of TRPV1 was awarded the Nobel Prize of Physiology or Medicine in 2021. If approved, resiniferatoxin may provide patients with long-lasting pain relief with a favourable safety profile. Grünenthal's Phase III programme will include more than 1800 patients with knee osteoarthritis who have exhausted available treatment options and still suffer from moderate to severe pain. Grünenthal will conduct three trials across approximately 200 sites across Europe, the US, Latin America, South Africa and Japan to investigate the efficacy and safety of intra-articular injections of RTX in adults. The efficacy endpoints observed in the trials mainly focus on an improvement in the pain and physical function score in the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index from baseline up to 52 weeks. Upon completion, the Phase III programme is intended to enable marketing approval for RTX in the EU, the US, and Japan. Grünenthal aims to submit a new drug application in 2024, leading to a potential market entry of RTX in 2025.

"More than 300 million patients suffer from osteoarthritis1, a progressive disease that currently cannot be cured. They often experience debilitating pain as a result of their condition," says Jan Adams, Chief Scientific Officer Grünenthal. "We strive to provide these patients with a non-opioid treatment option that combines long-lasting pain relief with a functional improvement of the affected joints."

"The global osteoarthritis market is expected to grow to approximately $ 11.0 billion in 20252," says Gabriel Baertschi, Chief Executive Officer, Grünenthal. "Patients are in need for innovative treatment options with better efficacy than current treatments, and without the side-effects of opioids."

Grünenthal holds the global rights for RTX since the acquisition of the Swiss biotech company Mestex AG in 2021. If the outcome of the Phase III programme is positive, the company intends to explore the potential of RTX for the treatment of osteoarthritis-related pain in additional joints beyond the knee.

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