Grünenthal Group

First participants enrolled in Clinical Trial with Nociceptin/Orphanin peptide receptor (NOP) agonist

Del

Aachen, Germany, 29 September 2021 –Today, Grünenthal announced that the first participants have been enrolled in a randomised, placebo- and active-controlled clinical trial for its peripherally restricted Nociceptin/Orphanin FQ peptide receptor (NOP) agonist. The compound is being developed to provide a non-opioid therapy option that offers a strong analgesic effect without the side effects commonly associated with opioids. The Experimental Medicine Trial will evaluate the extent and duration of the pharmacological effect of the oral NOP agonist in an experimental pain model. The results of the trial are expected to be available in early 2022.

The trial explores how the NOP agonist influences pain signalling and perception using laser evoked potentials (LEPs) in an experimental pain model with 30 healthy participants. On five different occasions, the participants will receive either the NOP agonist or pregabalin or placebo. The trial explores three different doses of the NOP agonist; pregabalin and placebo will be given to ensure control conditions. In the experimental pain model, a laser will generate a short tolerable painful heat stimulus on the participant’s skin which has been sensitised to mimic a temporary state of neuropathic pain. Both objective and subjective endpoints will be assessed in response to the laser stimuli, including electroencephalography (EEG) to measure brain activity and the Visual Analogue Scale (VAS) for subjective pain perception.

”This peripherally restricted, potent and selective NOP receptor agonist has shown analgesic effects in a wide range of pre-clinical pain models[1],” says Jan Adams, M.D., Chief Scientific Officer Grünenthal. “Millions of patients suffer from chronic neuropathic pain and are in need of better treatment options. With its unique mechanism of action, our NOP agonist may have the potential to provide these patients with a therapeutic benefit and an improved safety profile compared to the available standards of care.”

A First-in-Human clinical trial to assess the safety and tolerability profile and the pharmacokinetic characteristics of the NOP agonist is ongoing since December 2020. In addition, Grünenthal intends to start a Phase IIa trial to evaluate the compound’s efficacy in patients with painful diabetic peripheral neuropathy in 2022.

Grünenthal’s R&D pipeline includes multiple programmes across different targets, modalities and mechanisms of action to deliver better treatments for patients with severe pain conditions. In addition to developing its NOP agonist, Grünenthal is conducting a Phase I clinical trial with a Glucocorticoid Receptor Modulator (GRM) aiming to provide patients with a therapy option for chronic inflammatory diseases. Grünenthal recently announced the start of recruitment for a Phase III clinical trial with Qutenza® (capsaicin) 8% topical system in post-surgical neuropathic pain. In addition, Grünenthal intends to enrol the first patients with painful osteoarthritis of the knee in a Phase III clinical trial to investigate the efficacy, safety and tolerability of Resiniferatoxin by Q1 2022.

[1] Grünenthal Data on file

Kontakter

Christopher Jansen, Communication Business Partner
Phone: +49 241 569-1428
Christopher.Jansen@grunenthal.com

Florian Dieckmann, Head Global Communications
Phone: +49 241 569-2555
Florian.Dieckmann@grunenthal.com

Links

Information om Grünenthal Group

Grünenthal Group
Grünenthal Group

Aachen, Germany

Grünenthal is a global leader in pain management and related diseases. As a science-based, privately-owned 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 29 countries across Europe, Latin America and the US. Our products are available in more than 100 countries. In 2020, Grünenthal employed around 4,500 people and achieved sales of € 1.3 bn.

Følg pressemeddelelser fra Grünenthal Group

Skriv dig op her, og modtag pressemeddelelser på e-mail. Indtast din e-mail, klik på abonner, og følg instruktionerne i den udsendte e-mail.

Flere pressemeddelelser fra Grünenthal Group

Grünenthal, Uniklinik RWTH Aachen and RTWH Aachen University collaborate to advance pain research7.7.2022 09:05:00 CEST | Press release

Aachen, Germany – 7 July 2022 – Grünenthal, Uniklinik RWTH Aachen and RWTH Aachen University announced a collaboration to advance the development of next-generation pain medicines. The collaboration involves the institutes of Dr Angelika Lampert, Professor of Physiology at the Uniklinik RWTH Aachen and Dr Marc Spehr, Lichtenberg-Professor for Chemosensation at the RWTH Aachen University. The partners strive to develop a range of translational research tools and humanised preclinical models to enhance target validation. Under the terms of the agreement, Grünenthal will support the institutes led by Professor Lampert and Professor Spehr with approximately € 1 million of funding. Part of the funding allows for establishing two new post-doc positions. The exploratory efforts at the Uniklinik RWTH Aachen and RWTH Aachen University will, if successful, enable their subsequent integration into drug development activities at Grünenthal. Chronic pain is a considerable burden that impacts up to

Grünenthal and NovaQuest enter agreement to advance the resiniferatoxin global Phase III program in osteoarthritis29.3.2022 12:05:00 CEST | Press release

Grünenthal and NovaQuest announced today 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. 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. "Globally, more than 300 million patients suffer from osteoarthritis[1]. For many of them, the available treatment options are not suffici

Grünenthal donates 400.000€ and provides pain treatment medicine to Ukraine7.3.2022 13:16:33 CET | Pressemeddelelse

Aachen, Germany, 7 March 2022 Grünenthal, an international science-driven pharmaceutical company, announced that it has donated 400.000€ to the Red Cross to support humanitarian relief efforts in Ukraine and Eastern Europe. In addition, Grünenthal partners with Action Medeor and the University Hospital of RWTH Aachen to provide urgently needed pain medication to the region. The first transport with medicine is set to leave Aachen this week. “We are shocked and saddened by the attack on Ukraine. Our full solidarity is with Ukraine’s people and everyone affected, no matter where they come from. Grünenthal will contribute to ensuring urgently needed medical care”, said Gabriel Baertschi, CEO of Grünenthal.

First patient enrolled into a Phase III study with QUTENZA® in post-surgical neuropathic pain10.8.2021 09:00:00 CEST | Pressemeddelelse

The study AV001 aims to include the treatment of post-surgical neuropathic pain (PSNP) in the U.S. label. QUTENZA® is currently approved for the treatment of neuropathic pain associated with postherpetic neuralgia and for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults. Post-surgical neuropathic pain is a debilitating complication of surgery that affects approximately 13% of all patients who undergo surgery, representing 3.3 million patients per year in the US.[1] Aachen, Germany, & Morristown, N.J., 10 August 2021 –Grünenthal announced today that its U.S. subsidiary, Averitas Pharma Inc., enrolled the first patient in the randomised, double-blind trial AV001. The Phase III study investigates the efficacy, safety, and tolerability of QUTENZA (capsaicin) 8% topical system in post-surgical neuropathic pain (PSNP) to support an extension of the U.S. label. The trial will include over 400 patients who suffer from moderate to seve

Grünenthal’s Glucocorticoid Receptor Modulator enters clinical development27.7.2021 10:59:55 CEST | Press release

Aachen, Germany, 27 July 2021 –Grünenthal announced today that the first volunteers have been enrolled in a Phase I trial of its Glucocorticoid Receptor Modulator (GRM). The oral investigational medicine aims to provide a therapy option with broad anti-inflammatory efficacy and a more favourable benefit-risk profile compared to current glucocorticoid-based therapies like prednisolone. The Phase I trial includes 80 healthy volunteers and is designed as a head to head comparison between the GRM and prednisolone, the most frequently used glucocorticoid.[1] Observing several biomarkers, the trial will assess the influence of the investigational medicine on bone metabolism and glucose levels. Reduced bone formation leading to osteoporosis as well as increased blood glucose levels leading to an increased risk of diabetes are among the most common side-effects of glucocorticoids, which are a strong limitation for their long-term use at highly effective doses.[2],[3],[4] The results of the stu