• First patient was randomized in Phase II trial
• Study aims to demonstrate mode of action (MoA) of MP1032 in patients with COVID-19
• Study design comprises sites in Europe and the U.S.
MetrioPharm AG, a pharmaceutical company developing drugs for inflammatory diseases, announces today that it has dosed the first patient in a phase II study for its lead compound MP1032 against COVID-19. The study’s target is to determine if MP1032’s anti-inflammatory effect can slow down the spread of the virus in recently hospitalized patients with moderate to severe coronavirus disease, as well as alleviate COVID-19 symptoms.
MetrioPharm’s Chief Scientific Officer (CSO) Dr. Wolfgang Brysch comments: “MetrioPharm’s preclinical data suggest that our lead compound MP1032 is able to rebalance the patient’s hyper-inflammation, as well as reduce the SARS-CoV-2 virus spread in the body. The study focuses on moderately to severely ill patients, that have been recently hospitalized. This study design makes it possible to draw conclusions about efficacy even in smaller numbers of patients. In the medium and long term, we also see potential for MP1032 in the treatment of early disease stages and even in prophylaxis. With hyper-inflammation being one of the crucial factors in severe COVID-19 cases, we hope to contribute to treatment efforts, soon.”
The study aims to recruit about 120 patients in an early stage of hospitalization. Approximately 80 patients will receive MP1032 at a dose of 300 mg twice a day plus standard of care and about 40 patients will receive placebo plus standard of care. The trial is designed to be conducted in Romania, Hungary, Spain, France, and Italy, among others. MetrioPharm has also submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) which was granted “Study May Proceed” status by the FDA in August 2021 and is hence seeking to expand the trial to clinical sites in the United States.
In addition to confirming the safety of MP1032, the primary efficacy endpoint will be the percentage of participants with improved disease symptoms at Day 14, while undergoing treatment with MP1032. First topline data are expected as of H2 2022.
MetrioPharm’s Chief Executive Officer (CEO) Thomas Christély states: “MetrioPharm’s lead compound MP1032 has already demonstrated in several indications driven by chronic inflammatory processes that oxidative stress was stopped and inflammatory markers such as TNF-alpha, IL-6, IL-12 and others were downregulated. This should also demonstrate a positive effect in COVID-19 patients from an early stage of the disease and thus avoid severe COVID-19 progressions, especially since MP1032, being the first immune modulator, does not lead to a suppression of the immune system.”
In a previous Phase II study, MP1032 has already displayed a very good safety profile at 300 mg twice daily and demonstrated pronounced anti-inflammatory properties.
MP1032 is a novel small molecule ROS scavenger that is targeted at activated macrophages and inflamed tissues. The molecule acts as a self-regulating modulator to reduce cellular oxidative stress and the resulting inflammatory markers: due to its molecular structure, MP1032 is only active when it is exposed to elevated levels of reactive oxygen species (ROS). The molecule changes from its inert state (inactive) to a deprotonated form (activated); in this process only excess ROS are neutralized. Due to its self-regulated mode of activation, the effect of MP1032 is limited solely to the site of inflammation. MP1032 acts at the top of the inflammatory cascade and has demonstrated broad anti-inflammatory and anti-infective activity, as well as an excellent safety profile in preclinical and clinical studies.