Interview with... Dr. Kim Domela Kjøller, CEO at UNION Therapeutics

1) What inspired the foundation of UNION Therapeutics?
In essence, the team behind UNION Therapeutics cares about vulnerable patients, which is what drives and inspires the team to work towards covering unmet medical needs around the world. In 2013, UNION was awarded a larger grant to identify new antibacterial compounds and microbiome modulators on the basis of its advanced screening model. UNION shortly after discovered unappreciated effects in a well-established molecule and identified an opportunity to build an attractive IP position around the molecule. Further research documented the molecule (ATx201) to have a novel mode of action against bacteria alongside attractive anti-resistance properties. While UNION initially focused on antimicrobial activity, the scientific team discovered several of the compounds from the platform to also have novel anti-inflammatory properties, which enabled the pursuit of medicines for diseases across both infectious and inflammatory diseases.

2) Tell us about your novel anti-infective programme and how it can support Covid treatment in vulnerable patients?
UNION has two platform technologies; orismilast, a next generation PDE4 inhibitor available both orally and as a topical for inflammatory diseases, and niclosamide. UNION has worked with niclosamide since 2015, both as an anti-bacterial and anti-inflammatory agent. In early 2020, Institut Pasteur in Seoul found the potency of niclosamide to be 40 fold higher than that of remdesivir. UNION immediately started a program to develop new formulation and administration forms to develop into Ph1 programs, which was completed in the fall of 2020.

Shortly after successfully completing Ph1 – the results of which have just been published in the Lancet – niclosamid was selected for two platform studies in the UK.

The first - which now has started recruitment - is PROTECT-V, set out to investigate the nasal spray containing niclosamide as protection against SARS-COV-2 in high risk patients. This includes groups of patients with kidney disease requiring dialysis, in receipt of a kidney transplant, or with auto-immune diseases that might affect kidney function and require immunosuppression (e.g. vasculitis and glomerular diseases). These patient groups are also known to mount a suboptimal response to vaccination against viruses.

Dialysis patients typically need to attend their dialysis centre 3 times per week for at least 4 hours at a time and travel to dialysis centres by ambulance, car or taxi. It is impossible for them to self-isolate. Further, patients receiving dialysis may be less likely to benefit from admission to intensive care due to their comorbidity and the perceived prognostically deleterious impact of end-stage kidney disease. Those dialysis patients contracting COVID-19 have a 26% risk of death from the disease. To date, 11% of the UK’s in-centre dialysis population has contracted COVID-19. PROTECT-V includes 1500 patients randomized to niclosamide or placebo nasal spray, and is recognized by EMA as a potential registration study.

3) Why does the EU need a complement to vaccines for Covid-19 and what does UNION need to deliver this within Europe?
Vaccines play a crucial role in our efforts to control Covid-19The fact that several vaccines were able to be developed in such a short time since the pandemic started is impressive and gives hope. Yet, several factors are indicating that vaccines may not be sufficient on their own. The last few months have shown how the production and distribution of vaccines have been a limiting factor in curbing the spread of the virus - especially across continents. New mutations of the virus have also emerged as a worrying factor, posing still unanswered questions about the efficacy of the vaccine on the new types of the virus. Another very important consideration is that several vulnerable patient groups are not protected by vaccines, including people suffering from immunosuppression or autoimmune conditions, such as subjects of a kidney transplant, diabetes, cancer, leukaemia, malignant lymphomas, HIV, rheumatoid arthritis, multiple sclerosis. Effective treatment can therefore strengthen our response to both the current pandemic and future pandemics. Still, treatments should be seen as a complement to vaccines and not a substitute.

Additionally, individual Member States are increasing their search into treatment options - specifically, treatment targeting vulnerable groups to sustainability reopen our societies.

4) Could you share your plans for expansion over the next 5 years?
Over the next 5 years, UNION Therapeutics will work towards covering the unmet demand for vulnerable patients firstly by securing funds to scale production in EU-based facilities of UNI911 Covid treatment. Secondly, UNION will apply to get FDA approval in the US. Thirdly, UNION will work to expand the treatment drugs to low-income countries to further back the purpose of supporting unmet demand and vulnerable patients, exploiting the benefits of a treatment which is easy to handle from a logistical point of view, and which for the nasal spray can be administered by people themselves. Lastly, UNION will work for to further progress and commercialize orismilast across multiple inflammatory indications.

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