“The Path to the Clinical Trial”

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A conversation with Dr. Petra Schulz Discussing MetrioPharm’s Phase II Clinical Study in COVID-19

Dr. Petra Schulz, Senior Manager Drug Development at MetrioPharm

MetrioPharm is currently preparing a clinical trial of its lead compound MP1032 in COVID-19. How do you conduct study preparations under pandemic conditions?

The landscape has changed. Due to the pandemic, everything now runs digitally; for example, we are no longer in direct contact with the clinics and the investigators. And on-site monitoring is also affected by the restrictions. So there are a number of operational challenges.

How has MetrioPharm adjusted to these changes?

We are working with a large CRO (Clinical Research Organization) “Syneos Health”. They have medical experts in pulmonary and infectious diseases, for one thing. Secondly, they have set up a task force that specializes in conducting Covid-19 studies under pandemic conditions. This partner has now accumulated a great deal of experience, from which we can draw in our upcoming Phase II Trial.

Where will the study be conducted?

It will be very international. In total we want to carry it out in up to eleven different countries. Our focus will be on Europe, but the U.S. and Mexico are also planned to be included.

This involves an enormous amount of preparation. Why were so many countries selected?

There are currently many studies underway in the indication COVID-19, which is a positive development. But it also means that we are in a downright competitive situation regarding patients. At the same time, we have a tight schedule. The more countries and the more clinics we enroll, the faster we can get results. We also expect the pandemic to develop differently in different countries. By the respective vaccination strategies on the one hand and by possible mutations and new corona waves on the other hand. We will be able to assess many imponderables only as the study progresses. With an international study, we are less dependent on external factors in individual countries.

What is the design of the study?

Hospitalized patients will receive the respective standard therapy and additionally either MP1032 or a placebo for 28 days. If a patient is eligible for early discharge, they will receive the remainder of their study medication to take home. Four weeks after treatment, there will be a follow-up with a final examination. In total, we plan to randomize 120 patients.

A number of drugs are now being tested for the treatment of COVID-19. Where does MP1032 rank in this environment?

My assessment is that there are currently many antibodies being tested, but few small molecule compounds. A small molecule ROS scavenger like MP1032 will certainly have a special role.

What is happening between now and the start of the trial?

We need to identify as many trial centers as possible. In other words, recruit as many physicians as possible for the study and prepare them for the trial. In addition, all logistical preparations have to be completed. The medication, for example, must be packaged, labeled, tested and cleared. Due to the international scope, we will have to open depots on several continents to distribute the medication. We want to start treating patients in mid-2021.

What will you be able to learn about MP1032 from the trial?

This time we will not administer the molecule alone, but in addition to standard therapy, and that varies from country to country. Some patients will also get dexamethasone, some remdesivir, some another therapeutic. So, the analysis will be a challenge, we should not provide a forecast just yet. But the Lab data will be of great help to us in evaluating the accumulated results. We will be able to learn a lot from the trial, I am sure.

This interview is from MetrioPharm’s 2020 Annual Report. If you are interested in the entire Annual Report with all the facts, figures and background information, you can download it here.