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MetrioPharm AG: Last Patient Out: MetrioPharm Completes Clinical Phase II Trial in COVID-19
Zurich, 29.07.2022 (pta020/29.07.2022/12:50 UTC+2)
- The last patient had his/her last visit in MetrioPharm's trial in COVID-19 on July 28th
- Data cleaning and analysis will start subsequently
- Topline Data expected in Q4 2022
MetrioPharm AG, a pharmaceutical company developing drugs for inflammatory diseases, announced today that the last patient was examined in the ongoing clinical Phase II trial in COVID-19. The objective of the study is to determine whether treatment with MetrioPharm's lead compound MP1032 can slow the spread of the virus and alleviate COVID-19 symptoms in recently hospitalized patients. In preclinical trials the compound had shown both antiviral and anti-inflammatory properties.
MetrioPharm's Chief Scientific Officer (CSO) Dr. Wolfgang Brysch commented, "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. The team at MetrioPharm is now monitoring the validation of the data. Afterwards we will immediately start with the data analysis. Given the recurring increase in number of infections, as well as the occurrence of SARS-CoV-2 variants, the demand for therapies in COVID-19 will remain urgent. Especially for those deployed early in infection to stop replication of the virus and those that can be administered to address extreme illness. We aim to use our immunomodulator MP1032 to help alleviate COVID-19 symptoms in both, early and later stages and shorten hospitalizations."
The Phase II trial was conducted in multiple clinical centers in Romania, Hungary, Spain, Bulgaria and Italy. A total of 132 patients with moderate to severe coronavirus disease were randomized. 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 Q4 2022.
MetrioPharm's Chief Executive Officer (CEO) Thomas Christély explains, "There is still a great need for orally available and safe therapeutics for the treatment of COVID-19. The so far approved antiviral drugs are only effective in a limited time window within a few days after infection and have significant side effects. MP1032 as a first-in-class auto-regulated macrophage immune modulator with an outstanding safety profile can be administered independently of the stage of disease progression and thus may be an important addition, particularly to outpatient therapy for corona infection. We intend to develop our lead compound MP1032 with pharmaceutical partners also as Early Intervention and for Long COVID patients as well as for a number of chronic indications."
About the European Commission funding
MetrioPharm's Phase II study in COVID-19 is funded by the European Commission under the HERA Incubator. This funding program was launched in April 2021 to support urgently needed research and development to combat the corona virus and its variant across Europe.
MetrioPharm's iMPact project is part of a broad range of European Commission research and innovation activities to combat the corona virus.
The iMPact project was nominated for European Commission funding in July 2021, and the grant agreement was signed in November 2021.
About MetrioPharm AG
MetrioPharm AG is a clinical-stage biopharmaceutical development company focused on therapies for acute and chronic inflammatory diseases.
MetrioPharm is developing a novel class of self-regulating immunomodulators targeting activated macrophages and inflamed tissues.
MetrioPharm's lead compound MP1032 acts at the top of the inflammation cascade, where elevated levels of reactive oxygen species (ROS) trigger cellular oxidative stress and thereby a variety of disease processes.
MP1032 is a novel small molecule auto-regulated ROS scavenger. As a first-in-class immunomodulator, MP1032 does not suppress the immune system. The molecule targets cellular oxidative stress and thereby reduces inflammatory markers such as TNF-alpha, IL-6, IL-12, while ROS are maintained at physiological levels essential for normal cellular function.
Due to its molecular structure, MP1032 is only activated when it is exposed to elevated levels of ROS. The molecule then changes from its inert state (inactive) to a deprotonated form (activated). This activated form of MP1032 has pronounced immunomodulatory properties and neutralizes only excess levels of ROS. Thus, the effect of MP1032 remains limited to the site of inflammation.
MP1032 has demonstrated broad anti-inflammatory and anti-infective properties as well as an excellent safety profile in preclinical and clinical studies.
MetrioPharm has started to systemically examine the options for so-called fixed-dose combination therapies in other inflammatory indications where the current standard therapies show significant side effects. The goal is to combine lower doses of these mostly generic standard therapies with MP1032 in a single pill, thereby creating novel drugs with improved efficacy and fewer side effects and a renewed or extended patent protection.
MetrioPharm AG is headquartered in Zurich and has a subsidiary for R&D activities in Berlin.
This press release contains forward-looking statements that involve risks and uncertainties and are consistent with MetrioPharm AG's assessment as of the date of this release. Such forward-looking statements are neither promises nor guarantees but are subject to numerous risks and uncertainties. No liability or warranty, and no claim, if any, is made with respect to the timeliness, accuracy or completeness of such data and information, and no reliance should be placed on such data and information, either explicitly or impliedly.
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