Can we create a world free of pain?
Chronic pain affects hundreds of millions of people and puts a significant burden on society and the economy. Jan Adams, MD, Chief Scientific Officer at Grünenthal, shares insights into Grünenthal’s innovation strategy in pain and how the leading pain specialist has transformed in recent years.
Dr. Adams, why has Grünenthal specialized on pain research, seemingly a niche?
Pain is probably everything but a niche. It is a widespread illness and represents a significant burden for people and society. Based on data from 34 countries, experts estimate that the prevalence of chronic pain is between 20% and 40%. In the United States alone, an estimated 50 million to 100 million people have chronic pain, making it the most prevalent, costly, and disabling health condition in the US. Moreover, chronic pain was the leading cause of ‘years lived with disability’ in most countries worldwide in 2016.
Existing pain therapies work for some patients – but not for all. This is either because of a lack of efficacy, side effects, or for safety reasons. There is a clear need for innovative treatment options that provide better outcomes for larger patient groups.
Further, our scientific understanding of pain and its pathophysiology has massively improved in past years. That’s why we believe we are at the brink of significant progress in pain therapy, and Grünenthal wants to be a key driver of this progress.
How exactly will you drive your leadership in that therapeutic area?
Grünenthal is uniquely positioned in the therapeutic area of pain. Since the 1970s, we have focused on developing innovative pain therapies and have become one of the leading companies in this area. We have been able to bring numerous life-changing pain medicines to patients and therefore can build on a strong track record and significant experience.
To expand our leadership in this disease area, Grünenthal has constantly evolved. Today the company looks quite different from even just a few years ago. We have focused our organization on critical capabilities like disease understanding and translational science. These capabilities will differentiate us, and they will allow us to stay at the forefront of pain innovation. While we double down on these strategic capabilities crucial for a projects’ success, we have built a strong network of preferred partners to externalize operational tasks systematically. This way, we strike the right balance of deep in-house expertise and operational flexibility.
We emphasized collaboration and built networks with leading institutions, biotechs, CROs, and academic researchers worldwide. This enables us to access the best science wherever it exists and provides us access to new technologies that a midsized player like Grünenthal cannot implement on its own – for example, cell and gene therapy. We aim to be the partner of choice for anyone creating innovations in the therapeutic area of pain. This is why we increased our global reach and established an Innovation Hub in Boston, MA, to get closer to the vibrant North American eco-system of emerging start-ups and biotechs.
Most importantly: we can draw on the vast expertise and the unwavering commitment of our scientists and colleagues across Grünenthal. We have outstanding people, and we work hard to create an environment that allows everyone to grow as an individual and thus also moves Grünenthal forward as an organization.
Does Grünenthal pursue a specific focus in its R&D activities?
We have strategically decided to focus our R&D activities on innovative non-opioid pain medicines in four indications characterized by a huge unmet medical need, a profound understanding of the underlying pathophysiology, and, thus, a high technical and scientific feasibility. These indications are peripheral neuropathic pain, chronic postoperative pain, chronic low back pain, and osteoarthritis. By targeting these indications, we strive to maximize our positive impact on patients’ lives – through our own research and by drawing on external innovation, collaboration, and networks.
At the same time, we have become highly rigorous in selecting the projects we invest in, whether internally or externally. Many of our efforts go into identifying the most promising opportunities to develop the next generation of pain medicines. With that often come tough decisions – we would not pursue a project, for example, if the human validation of a potential therapeutic target does not meet our requirements. However, we firmly believe that focusing on the most promising opportunities is essential, as we cannot afford to allocate resources on projects with a low likelihood of success.
Looking ahead, what can we expect from Grünenthal?
Our R&D pipeline consists of innovative assets with well-validated mechanisms of action at all stages of research and development. As a result, we see good progress. Let me mention a few examples:
Some months ago, the US-FDA approved our sNDA for Qutenza® for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults. Painful DPN is the most significant neuropathic pain indication in the US. Building on this success, we are pursuing a pivotal Phase III study in post-surgical neuropathic pain (PSNP) to further expand the label in the United States. PSNP is a complication of surgery that affects approx. 3.3 million patients per year in the US.
In the last six months, we progressed two investigational medicines into Phase I clinical studies: a peripherally restricted, highly selective Nociceptin/orphanin peptide receptor (NOP) agonist, an oral investigational therapy with a unique mechanism of action for the treatment of chronic peripheral neuropathic pain. In addition, Grünenthal develops a Glucocorticoid Receptor Modulator (GRM) for inflammatory conditions. We expect to see the start of further Phase I studies in the next 12-24 months, as our research strategy starts to pay off.
Besides, we continue to strengthen our portfolio through external innovation. Just this month, we acquired Mestex AG, a Swiss biotech company that has developed an innovative investigational medicine for the intra-articular treatment of pain associated with osteoarthritis of the knee. It is a non-opioid treatment option with a well-validated mechanism of action that may positively impact the lives of millions of patients who currently receive intra-articular corticosteroids or need to undergo knee replacement surgery as the last remaining treatment option. We will progress this program into global Phase III development still in 2021.
We have made substantial steps towards bringing new therapy options to patients and move closer to Grünenthal’s vision of a world free of pain.
 Elzahaf et al.; 2012.
 US Department of Health and Human Services; 2019.
 Vos et al.; 2017.