The iMPAct project: a small molecule for treating mild to moderate COVID-19
In a string of articles we will explore various themes of the iMPAct project. Today we will look through the magnifying glass and discover what exactly the iMPact project is about, when it started, who is involved, and where it will go.
The current global COVID-19 pandemic has caused severe health and socio-economic challenges. Despite significant improvements in the treatment of critical COVID-19 patients and advances in vaccine development, there is still an urgent need for safe and effective early intervention treatments. This, coupled with the occurrence of SARS-CoV-2 variants, highlights the necessity for COVID-19 therapies. To reduce disease burden, hospitalization time, and mortality, it is of critical importance to halt disease progression in early stages.
The ‘iMPact’ project was awarded a €7.9 million grant from the COVID-19 work programme from Horizon Europe in 2021, to clinically validate the small molecule compound MP1032, in an early intervention treatment against mild-to-moderate COVID-19.
Dr Wolfgang Brysch
MP1032 is a novel, orally available immune-modulator with strong anti-inflammatory effects. It is the lead candidate from the Swiss clinical-stage biopharmaceutical company MetrioPharm. MetrioPharm’s mission is to create new therapies for acute and chronic inflammatory diseases. While MP1032’s initial disease indication has been chronic diseases, early on during the pandemic it became clear that it also was found to have strong anti-viral effects.
“While our focus remains in treating chronic inflammatory diseases, in early 2020 we started thinking that maybe our drug, which is a very safe anti-inflammatory drug, could be of value in treating COVID-19, an acute inflammatory disease. We felt compelled to try this,” Dr. Wolfgang Brysch, Chief Scientific Officer and Chief Medical Officer of MetrioPharm explained.
Early in the pandemic -in collaboration with the Virology lab at the University of Erlangen-Nuremberg- MetrioPharm tested MP1032 against SARS-CoV-2 in preclinical viral infection models and found that this molecule had potent anti-viral effects. Soon after, in August 2021 the iMPact project officially commenced testing its ability to stop COVID-19 disease progression in a phase IIa trial.
The challenge: recruiting patients during a pandemic
With clinical trial sites in Romania, Hungary, Spain, Bulgaria and Italy, the iMPact project bundled European expertise and efforts to combat the current pandemic. A multi-site study in and of itself is challenging and even more so when the clinical trial takes place in the middle of a pandemic. However, on March 02, 2022 the first milestone was reached, wherein 50% patient enrollment was achieved.
“My sincere appreciation goes to the clinical teams on site in the respective hospitals, who are managing this trial in COVID-19 with great, often personal, commitment in the face of high, regular workloads that this pandemic causes,” says Dr Wolfgang Brysch.
Just 5 months later the study completed its recruitment of 120 patients in early stage hospitalization.
“The clinical investigators have done tremendous work under very challenging circumstances. We are grateful to all of them, and also to all the patients, who made this trial possible,” states Dr Wolfgang Brysch.
Now that the clinical trial has closed, MetrioPharm has begun to analyze the data. The project now moves to a new phase of carefully evaluating the data and depending on the results of the clinical trial, the iMPact project will hopefully lay the foundation for follow-up rapid phase IIb/III development and market registration.
To get the compound to the patients- what needs to happen?
Alongside the clinical trials vital to the iMPact project, a lot has been accomplished in several other teams working simultaneously. In this new series we will bring to light the challenges of running a clinical trial during a pandemic, MP1032’s effect on viral variants, communicating these results to relevant stakeholders, and managing their expectations.
When moving from the pre-clinicial phase to clinical trial stages, the amount of trial medication that is needed increases dramatically. Once it is authorized to be put onto the market it has to be distributed to patients in need, which increases production requirements even further. In a fast changing situation like the COVID-19 pandemic it is essential to do steps in parallel – such as planning upscaling of manufacturing already during the clinical trial phase.
In our next article we will therefore explain what needs to be considered during manufacturing and how upscaling is already prepared for in the ongoing iMPact project.
Posted on the 24th of October 2022.