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] The results of the study are expected to be available in the first quarter of 2022.

"Millions of patients rely on glucocorticoid-based therapies to manage their condition and are therefore at risk to experience severe side effects", says Jan Adams, M.D., Chief Scientific Officer, Grünenthal. "We strive to increase the quality of life for these patients during long-term treatments by providing a therapy option that delivers a broad anti-inflammatory efficacy with significantly fewer side effects."

The investigational medicine is a Grünenthal proprietary development and is currently the most advanced compound of the company's Glucocorticoid Receptor Modulator programme. Preclinically, the compound has shown anti-inflammatory properties comparable to prednisolone with a lower risk of glucocorticoid receptor mediated side effects.

This Phase I trial is Grünenthal's latest milestone in progressing its research pipeline. Recently, the company announced another Phase I trial with its Nociceptin/Orphanin Peptid Receptor (NOP)-agonist for the treatment of chronic neuropathic pain. In addition, Grünenthal announced several Phase III studies investigating the efficacy, safety and tolerability of Qutenza* (capsaicin) 8% topical system in post-surgical neuropathic pain (PSNP) and the efficacy, safety and tolerability of Resiniferatoxin in patients with pain associated with osteoarthritis of the knee. Both programmes are expected to start in 2021.

About Glucocorticoids

Glucocorticoids are a class of corticosteroids derived from the steroid hormone cortisol. Glucocorticoids are potent anti-inflammatory agents regardless of the cause of the inflammation and thus are used to suppress various allergic, inflammatory, and autoimmune disorders and to treat diseases caused by an overactive immune system. Long-term administration of Glucocorticoids can lead to a number of side effects, including osteoporosis and diabetes.

About Grünenthal

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.

More information: www.grunenthal.com

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