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    By Anna Lynch and Valeria Iansante

    In early 2020, before the coronavirus crisis hit, we were talking with Atriva about a new treatment for seasonal flu. Atriva is a small, German life sciences company that develops medicine for viral infections. No one had any idea at the time that this company might help fight the pandemic.

    When COVID-19 exploded a few months later, the European Investment Bank reached out to a broad group of  life sciences companies to see how they might help tackle the growing pandemic. Everyone at the Bank agreed that we should cast a wide net for this crisis.

    We were already in an appraisal process with Atriva in early 2020, and the company had said at the time that it preferred to keep focusing on influenza treatments. But then, a few weeks later, Atriva got back in touch to say they were seeing promising laboratory results for their lead product that might treat coronavirus illnesses.

    We ended up approving a €24 million loan to help Atriva do research into COVID-19 and other infectious diseases. The company’s clinical trials are now showing early successes for people who get very sick with the coronavirus.

    Europe is trying to speed up vaccines and therapies innovation. In May 2020, the European Commission released a strategy calling for more support to speed up trials and bring the most promising therapeutics to the market. The plan addresses research, development and innovation, optimising clinical trials and supply chains, providing regulatory flexibility and improving international cooperation. To deal with the pandemic, we also now have the European Health Emergency Preparedness and Response Authority (HERA), an initiative that will help us respond faster to cross-border threats.

    New treatments for COVID-19 must be authorised by a regulatory authority. Within the EU, this is the European Medicines Agency. The agency is evaluating five treatments for which marketing requests have been submitted, with one candidate under a rolling review. Rolling review means that the applicant continuously submits data as it is generated, which can speed up approval of medicines or vaccines. Three treatments have received EU approval – the antiviral drugs Veklury (remdesivir), Regkirona (regdanvimab) and Ronapreve (casirivimab/imdevimab). Veklury is for people who have developed pneumonia or became so sick that they require supplemental oxygen. Regkirona and Ronapreve help people with COVID-19 who do not require supplemental oxygen but who are at an increased risk of getting very ill.

    Trial and error for a changing virus

    Currently, hospitals are treating serious COVID-19 infections mainly with medicines that have been developed for other diseases, such as the use of steroids to reduce the inflammatory process triggered by the infection. For patients sick enough to be hospitalised and on oxygen, there are two main types of treatment in use in many countries: anti-inflammatory medicines to dampen the immune response and antiviral medicines to stop the virus from replicating. A popular anti-inflammatory medicine for COVID-19 patients is dexamethasone, which is a steroid commonly used to treat many other illnesses. As mentioned earlier, there are also anti-viral therapies originally developed to treat HIV/AIDS, hepatitis C and Ebola.

    A lot of research is taking place around the world into a wide variety of old and new medicines that could help people once they are hospitalised, but the options are still limited. It is unlikely that there is a magic bullet for COVID-19 right now, nor a one-size-fits-all therapy. Steroids aren’t good for all patients. Antivirals show promise but may not work for everyone, either. An antiviral treatment that helps in one stage of illness for a younger person may not work for an older person or someone with different symptoms. Frequently, severe COVID-19 patients suffer from hyper-inflammation and exhibit features of a cytokine storm syndrome, which in simplified terms is an over-reaction of the immune system that can lead to organ failure. Therefore, we need a cocktail of treatments that can be combined in different ways to address multiple symptoms at the same time. Because of this, we need to be open to new products that may need more support or investment, regardless of the size of the company. At the European Investment Bank, we haven’t shied away from these tough life science challenges, which is why we worked with companies such as Atriva and BioNTech in the early clinical development stages.

    A big mountain to climb

    It takes a long time to make a therapeutic drug. It can take 10-15 years to go from the laboratory bench to the patient’s bedside. Creating treatments quickly is a big mountain to climb. Now that people are experiencing long-term symptoms from COVID-19, that search for treatments becomes even more complex. At the same time, the European Investment Bank and other investment institutions know that we need to continue working on other important disease projects in areas such as Alzheimer's, oncology, tuberculosis, influenza, bacterial infections. There are many health problems around the world. We are doing a fine balancing act of our time and financing.

    To accelerate development, most pharmaceutical companies are repurposing established treatments or using ongoing research to identify COVID-19 therapeutics. To ensure that we are able to combat this pandemic and be prepared for the next crisis, including giving companies the support they need, we need to come together as a society and give a higher priority to infectious disease research. It is imperative that we create an environment that gives incentives to research and provides a viable commercial model for products targeting infectious diseases.  As we have seen during the pandemic, a lack of support and research can quickly disable our healthcare systems and economies.

    The European Investment Bank has been working closely with the European Commission and other institutions to create financial tools that foster more research and support the whole life sciences sector. A key investment tool we have is the Infectious Diseases Finance Facility. This tool allows us to offer venture debt financing for companies active in infectious diseases, vaccines, drugs and diagnostics. Investments made under this facility are backed by the European Commission, enabling us to take more risk for research and development, clinical trials, and market access of products. Future funding tools are under discussion to let us tailor more finance where it is needed the most.

    How to fight the variants

    The question now is what can be done to fight the coronavirus variants. Vaccination is imperative to prevent serious illness and hospitalisation. We also need to ensure that we reduce the spread of the virus with mask wearing and social prudence. When the virus is spreading, it has the best opportunity to mutate and produce variants. The variants might be an area where we run into difficulties with treatments. But even with the more contagious or virulent variants, we will keep using anti-viral and anti-inflammatory treatments when people get extremely sick. Some of these anti-viral treatments may need to be tweaked to fight certain variants. Monoclonal antibodies represent another treatment area. They are antibodies specifically engineered to fight the SARS-CoV-2 virus. They are given in high concentrations to patients to neutralise the virus and block a part of the virus that is essential for its invasion. This type of treatment is especially important for high-risk groups, including the elderly. Regkirona and Ronapreve are currently the only antibody treatments authorised for use in COVID-19 patients. However, many more are under development.

    Anna Lynch and Valeria Iansante are life sciences specialists at the European Investment Bank