01 Jan Life sciences sector shines through implicit collaboration
Kim Domela Kjøller, CEO, UNION therapeutics, details the reasons Denmark’s life sciences sector is so advanced and the company’s current focus on creating treatments in immunology and infectious diseases.
Why is Denmark’s life sciences sector so well developed?
There are three reasons for Denmark having one of the best life science sectors in Europe. The first is that Denmark is a small country with a high degree of trust. We establish public-private partnerships across sectors. Members of the Danish Life Science Cluster include communities and regions with a primary, secondary and tertiary healthcare system, biotech and medtech companies and universities. We think of how we can bring better health solutions to the population with each segment playing its own part; we think as one. A good example of the Danish ecosystem that UNION benefits from is in the development of orismilast for the treatment of hidradenitis suppurativa. We are supporting an investigator-initiated study at a Danish university hospital. One of the leading key opinion leaders working on treatment of hidradenitis suppurativa reached out to us and asked us to perform a proof-of-concept study. In general, it is a difficult disease to treat. We work together from different areas of the life science sector to promote a positive agenda.
Another key strength of Denmark’s life science sector is our high level of digitization. When we think about how we can deliver healthcare, we try to include smartphones. Using smartphones to deliver smarter health treatments makes sense from both a hospital and individual perspective. For example, patients do not necessarily have to go in for checkups. This has advantages in terms of sustainability because we do not need to relocate ourselves to another location, which cuts down our carbon footprint. Digital activity can not only bring better health solutions but has interesting ripple effects.
The last unique element is Denmark’s health data. In 2000, there was an article in Science magazine that used the Danish twin registry as a prime example for collecting medical data. We have very good health registries with data including all medicines everyone has picked up at the pharmacy since the mid-1990s, and records of hospitalizations covering all Danish citizens going back to 1977. We also have a cancer registry that goes back to 1943. The data source is enormous, and we can learn a lot from it. Denmark also runs one of the highest levels of clinical studies in the world. In terms of publications, we are one of the most productive countries per capita, including high-impact publications. We think about how data will be used and generate better data to progress the general health of Danish and global citizens alike.
Can you give us an overview of UNION therapeutics’ current operations?
UNION is a late-stage biotech company focused on immunology and infectious diseases. Around 2015, UNION identified niclosamide as an antihelminthic molecule. The chemical also has anti-inflammatory properties. We decided to focus on immunology and acquire the phosphodiesterase-4-inhibitor orismilast. The UNION team has more than 175 years of experience in pharmaceuticals. We have developed and commercialized 15 drugs on the global market. Our team also includes biotech entrepreneurs that think outside the box; we are always asking questions. Our seasoned people know what good looks like and challenge the existing status quo. The core of what we do at UNION is a strict focus on developing best-in-class treatments for patients in immunology and infectious diseases. Globally speaking, immunology is the second largest and fastest growing segment of the therapeutic arena. We still have phenomenal unmet medical needs. With orismilast, the first indications we are going to pursue are in immune dermatology, or skin disease, namely the three following diseases: psoriasis, atopic dermatitis and a rare disease called hidradenitis suppurativa.
Atopic dermatitis is the most prevalent skin disease among the inflammatory skin diseases, yet treatments are sparse. Up until 2017, it was mainly topical and old immunological treatments that often had side effects. If you have a moderate-to-severe skin disease covering a large part of your body, using topical medicine is not easy to do day in and day out. It requires systemic therapy. No good systemic therapies were available on the market until Dupilumab was launched. The atopic dermatitis market went from around $1 billion to more than $5 billion, which speaks to this huge unmet medical need. There are no safe oral treatments for patients with moderate skin disease. Orismilast addresses a high unmet need. Last year we submitted an application to the Food and Drug Administration to fast-track designation subsequently granted for oral orismilast for the treatment of atopic dermatitis. Orismilast has a broad applicability in immune diseases and can potentially work on asthma, irritable bowel disease, inflammatory skin diseases and even rheumatological conditions. We have a proof of concept for orismilast being used to treat psoriasis and atopic dermatitis; orismilast has shown efficacy in immune dermatology diseases. The current clinical development program for orismilast is leading towards its last stage before registering the product. The phase, which is called two B, enables us to go into phase three. After that, we can expand the chemical into multiple other indications within immunology.
What impact has the COVID-19 crisis had on the medical sciences sector?
The COVID-19 pandemic is a global challenge and an opportunity for pharma and biotech companies to research and develop new treatments supported by regulatory authorities. It has afforded us faster ways to support approval and use of novel medicines. UNION has together with U.K. researchers identified an unmet need related to COVID-19, which is prophylaxis for immunocompromised and high-risk patients. Our nasal spray was selected by the U.K. platform study PROTECT-V. The V here stands for vulnerable patients. These are patients that have immune compromised systems, such as people undergoing dialysis or kidney transplants that are on medication that suppresses their immune system. Immunocompromised patients had a mortality of 21.8 percent when getting COVID-19, which is extremely high. The average mortality rate at the same time period was around 2.4 percent. After vaccination, mortality rates of these patients was only 14.5 percent. Immunocompromised patients often do not respond that well to vaccination because they cannot make the necessary antibodies. Although this patient population were vaccinated first, they do not get the same protection as the rest of us. Immunocompromised patients are a population that have high unmet medical needs; we currently do not have good treatments to protect them. Our niclosamide nasal spray is tested to be used prophylactically for up to nine months. Our aim is to show that we can prevent patients from contracting SARS‑CoV‑2. When we have positive data, we have already agreed with the European Medicines Agency to use our data for the registration of a new prophylaxis treatment for COVID-19.
Life science is and has been for years an integrated part of how we deliver health in Denmark, which is not necessarily the situation outside of Denmark. The COVID-19 pandemic saw positive contributions in vaccines. The speed with which pharma companies have been able to bring it forward and help all of us to better control the pandemic has been promising. Positive contributions by the pharmaceuticals sector have become clearer to the population at large. In Europe we see the need to pay more attention to the sector. Potentially, Denmark is a little more advanced in this arena. We are currently developing niclosamide for prophylaxis treatment of COVID-19 patients. In this development, UNION has greatly benefited from Denmark’s positive life science ecosystem. The innovation foundation supported the early development of niclosamide. Our phase one study was done at local Danish hospitals in 2020. The study finished the same year and shortly after we started late-stage clinical studies. That fast progression was only made possible because of our strong ecosystem in Denmark.