news aktuell GmbH

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

Del
  • Global Phase III programme to enable marketing authorisation in the EU, the US and Japan for an innovativenon-opioid investigational medicine.
  • The programme will be conducted across approx. 200 study sites and include more than 1800 patients suffering from pain associated with osteoarthritis.
  • Globally, more than 300 million patients suffer from osteoarthritis[1]. The global osteoarthritis market is expected to grow to approximately $11.0 billion in 2025[2]. 

Aachen, Germany – 18 August 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.

About RTX

RTX is an intra-articular injection of resiniferatoxin developed for the treatment of pain in patients with moderate to severe pain associated with knee osteoarthritis. Resiniferatoxin is a highly potent Transient Receptor Potential Vanilloid 1 (TRPV1) agonist. Its administration can reversibly defunctionalise TRPV1-expressing nociceptors. This may result in long-lasting pain relief. Initial data shows a long-lasting and significant analgesic effect and functional improvements compared to placebo, as well as a favourable safety profile.

About Osteoarthritis

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 several related factors include female gender, genetics, metabolism, and excessive mechanical stress. The diagnosis of OA is primarily based on the 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.[3]

Osteoarthritis is a joint disease in which the tissues in the joint break down over time. Common symptoms of osteoarthritis include joint pain, stiffness and swelling, as well as changes in how the joint moves and feeling like the joint is loose or unstable. The most commonly affected joints include the knees, hips, hands, neck and lower back. Treatment of osteoarthritis usually includes exercises, maintaining a healthy weight, wearing braces to help with stability, and taking medication, if prescribed.[4] Many patients will ultimately require joint replacement surgery.

About Grünenthal

Grünenthal is a global leader in pain management and related diseases. As a science-based, fully-integrated pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We are focusing all of our activities and efforts on working towards our vision of a world free of pain.

Grünenthal is headquartered in Aachen, Germany, and has affiliates in 28 countries across Europe, Latin America and the US. Our products are available in more than 100 countries. In 2021, Grünenthal employed around 4,500 people and achieved sales of € 1.5 bn.

More information: www.grunenthal.com

Click here for our Grünenthal Report 2021/2022

Follow us on:

LinkedIn: Grunenthal Group

Instagram: grunenthal

For further information please contact

Christopher Jansen

Communication Business Partner

Grünenthal GmbH

52099 Aachen

Phone: +49 241 569-1428

E-mail: Christopher.Jansen@grunenthal.com

Florian Dieckmann
Head Global Communication
Grünenthal GmbH

52099 Aachen

Phone: +49 241 569-2555

E-mail: Florian.Dieckmann@grunenthal.com

[1] Cieza, A., Causey, K., Kamenov, K., Hanson, S. W., Chatterji, S., & Vos, T. (2020). Global estimates of the need for rehabilitation based on the Global Burden of Disease study 2019: a systematic analysis for the Global Burden of Disease Study 2019. The Lancet, 396(10267), 2006-2017.

[2]MarketsAndMarkets Report; Osteoarthritis Therapeutics Market by Anatomy (Knee, Hand), Drug Type (NSAIDs, Analgesics, Corticosteroids), Route of Administration (Parenteral), Distribution Channel (Hospital Pharmacies),Purchasing Pattern (Prescription Drugs) - Global Forecast to 2025; 2020. https://www.marketsandmarkets.com/Market-Reports/osteoarthritis-therapeutics-market-209565994.html

[3] ICD-11 https://icd.who.int/browse11/l-m/en#/http%3a%2f%2fid.who.int%2ficd%2fentity%2f558562409

[4] National Institute of Arthritis and Musculoskeletal and Skin Diseases; What Causes Osteoarthritis, Symptoms & More | NIAMS (nih.gov)

Om news aktuell GmbH

news aktuell GmbH
news aktuell GmbH
Mittelweg 144
20148 Hamburg

+49 (0)40 4113-32589http://www.newsaktuell.de

As wholly owned subsidiary of dpa, news aktuell provides business and organizations with effective access to media and consumers. Via the smart tools ots and zimpel, PR content accesses all media formats, including classical print, high click-rate online portals and social networks. In addition, news aktuell publishes all its customers’ PR content on www.presseportal.de, one of the PR portals with the greatest reach in Germany. By this means, all the relevant multipliers are reached globally, from editors, via digital influencers right up to specialist bloggers and interested consumers. news aktuell has been on the market since 1989. The company, with a staff complement of more than 135, has its headquarters in Hamburg. Other offices are in Berlin, Dusseldorf, Frankfurt und Munich.

Følg pressemeldinger fra news aktuell GmbH

Registrer deg med din epostadresse under for å få de nyeste sakene fra news aktuell GmbH på epost fortløpende. Du kan melde deg av når som helst.

Siste pressemeldinger fra news aktuell GmbH

Bertelsmann Stiftung: Europeans’ support for Ukraine continues unabated5.10.2022 11:00:00 CEST | Press release

Europeans continue to stand firmly by Ukraine's side. A broad majority supports arms deliveries. The willingness to accept Ukraine into the EU remains high. There is also strong support for the need to become more independent in terms of energy supply - even if this means personal cuts. Nevertheless, these attitudes cannot be taken for granted, as there are initial signs that approval is crumbling.

BookSmart24: New app for environmentally conscious travel finds the lowest CO2 route to the desired destination3.10.2022 08:50:00 CEST | Pressemelding

(London, United Kingdom): While existing travel websites primarily display the cheapest or fastest travel option, the new BookSmart24 app also finds the most CO2- and emission-efficient variant for the chosen route. The platform enables users to make smart and responsible booking decisions and to realize that traveling in an environmentally conscious manner does not necessarily have to be more expensive. SmartChoice: CO2-reduced travel does not have to be more expensive BookSmart24 puts the avoidance of CO2 and other harmful emissions in the foreground. The result is the BookSmart24 SmartChoice: It shows users how to make a comfortable and at the same time environmentally friendly and cost-saving booking decision. Thanks to the clear and simple operation of the app, the end consumer receives information on the environmental impact of his or her journey and also sees at a glance: flying more environmentally conscious does not mean that it has to be much more expensive.The cost differenc

Hankook iON Winter: new winter tyre for EVs29.9.2022 10:00:00 CEST | Press release

(Neu-Isenburg, Germany) – Following on from the Hankook iON evo summer tyre, the new Hankook iON Winter is the second member of the new global “iON” tyre family designed specifically for electric vehicles. The premium tyre maker thus aims to promote electric mobility even in the cold season. Characteristics of the new tyre include reduced rolling resistance and low rolling noise. Compared to conventional tyres, this means more range per battery charge and a better driving experience. In addition, the new Hankook iON products are specially designed to deal with the instant high torque produced by powerful electric vehicles. A special challenge: winter tyres for electric cars The Hankook iON Winter has a specially developed tread compound that ensures the lowest possible rolling resistance without sacrificing performance on wet and snow-covered roads. Natural oils ensure the necessary grip, even at low temperatures. The exceptional flexibility allows the tyre to adapt to the road surface

Hankook Tire Europe GmbH: Hankook and Formula E celebrate partnership launch28.9.2022 08:48:16 CEST | Press release

(Seoul, Korea/Neu-Isenburg, Germany) – As of next season, Hankook will be the new and exclusive technical partner and tyre supplier of the ABB FIA Formula E World Championship. At an event in The Swarovski Crystal Worlds in Austria, Hankook officially presented the newly developed Hankook iON race tyres to guests and representatives of Formula E, as well as the international media. The new tyre has been developed in close cooperation with the racing series and is particularly aimed at meeting the sustainability needs of Formula E and the future of e-mobility, without compromising motorsport performance, of course. Nearly 30 percent of the new tyre, which is specially tailored to the third generation of Formula E race cars, is made of sustainable materials. The Formula E teams currently have access to a tyre variant that can be used in both dry and wet conditions, in order to further save resources. Furthermore, the long durability of the tyre is another pioneering step. After the respe

I vårt presserom finner du alle våre siste pressemeldinger, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom