— Results of clinical trial CT-05 in 131 hospitalized patients with COVID-19
— Trial data demonstrate that MetrioPharm´s lead compound MP1032 has comparable efficacy to remdesivir with several additional benefits
— Results have been published in The Lancet Regional Health – Europe
MetrioPharm AG, a biotech company developing drugs for inflammatory and infectious diseases, announced today that results from its clinical trial CT-05 in hospitalized patients with moderate to severe COVID-19 have been published in the renowned journal The Lancet Regional Health – Europe.
CT-05 was a multicenter, randomized double-blind, placebo-controlled Phase IIa trial in 6 European countries, supported by a EUR 7.9 million grant from the European Health Emergency Preparedness and Response Authority (HERA). A total of 131 COVID-19 patients were treated with Standard of Care (SoC) plus MetrioPharm’s lead compound MP1032 or with placebo. Patients treated with MP1032 (n=86) exhibited a lower mortality compared to those receiving placebo + SoC (n=45). The study demonstrated that in terms of early recovery from the disease and time to discharge, MP1032 exhibits comparable efficacy to remdesivir, with the additional benefit of excellent safety and oral availability. Moreover, the efficacy of MP1032 was enhanced when used in combination with anti-viral agents, including, but not limited to, remdesivir.
”Conducting this clinical trial amid the pandemic came with many challenges. This limited the possibility of obtaining statistical significance for the primary endpoints according to standard WHO protocols. These protocols had been defined with much larger studies in mind,” said MetrioPharm CSO and co-founder Dr. Wolfgang Brysch. “The results were nevertheless very strong. We have shown a clear therapeutic potential for our lead compound MP1032 in COVID-19. Most importantly, while most antiviral drugs target specific viruses, MP1032 acts as a host-directed therapy. This novel approach to antiviral therapies can potentially treat emerging and even completely novel viruses without prior adaptation, which is essential for future pandemic preparedness.”
“An average of 2.4 days earlier discharge from hospital after 14 days of treatment with MP1032, an average of 4 days shorter ICU stay and faster recovery – these results alone are a great outcome for our trial of MP1032 in COVID-19,” said Thomas Christély, CEO of MetrioPharm. “These properties are currently being further investigated, as they would make MP1032 a very promising option for a broad first-line therapeutic and prophylactic treatment option to protect at-risk populations against new, emerging viruses. In addition, we have a strong rationale to suggest potential for the treatment of Long Covid which remains a problem for a large patient population. MP1032, with its host-directed mechanism of action, addresses four key drivers of this new indication: a persistent virus, immune mitochondrial dysregulation, micro-embolisms, and pulmonary fibrosis. Although our current development focus is on rare and orphan diseases, we will continue to develop MP1032 in a range of infectious diseases, some of which with pandemic potential, subject to further support from large public grants.”
You can find MetrioPharm’s publication on MP1032 in patients with COVID-19 here.
MP1032 is a unique small molecule targeting overshooting reactions of activated immune cells by addressing a central, natural metabolic process occurring in activated immune cells. The mitochondria of these cells react to the activation by boosting their energy metabolism, which in turn leads to the generation of reactive oxygen species (ROS) and an increase of intercellular pH. MP1032 is activated only by clusters of elevated pH and acts as an ROS scavenger, normalizing the pathologically increased ROS levels (oxidative stress). Once the pH returns to normal, the drug stops is no longer activated and working. This unique, self-regulating mechanism of action makes MP1032 a first-in-class anti-inflammatiory drug that reduces excessive ROS without interfering with the physiological ROS levels of other cells, that are essential for normal cell function, resulting in an excellent safety profile.
MetrioPharm AG is a Swiss biotech company developing first-in-class auto-regulated immune modulators targeting the pathologically dysregulated mitochondrial metabolism in macrophages. MetrioPharm’s platform of oral small molecules has demonstrated preclinical & clinical efficacy (three Phase II studies) in several inflammatory and infectious diseases with an excellent safety profile.
As a monotherapy, MetrioPharm’s lead candidate MP1032 produces therapeutic effects similar to corticosteroids (cortisone-based therapeutics), but without serious side effects.
MP1032 has demonstrated synergistic/supra-additive effects in combination with an ultra-low dose (10% of the normal dose) of corticosteroids, demonstrating the potential to create a new class of “super corticosteroids” that are more effective and have no serious side effects. For more than 60 years, there have been no major advances in achieving such corticosteroid-sparing therapy and thereby reducing corticosteroid-specific side effects.
In addition, MP1032 has demonstrated broad host-directed antiviral activity in preclinical studies against 6 tested COVID-19 variants and multiple influenza virus variants, as well as antibacterial activity against multiple bacterial strains.
The Company is headquartered in Zurich and has a subsidiary for R&D activities in Berlin.
About the European Commission funding
This project has received funding from the European Union’s Horizon Europe program 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. The grant agreement No. is 101046182.
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.
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 and are subject to numerous risks and uncertainties. No representations or warranty is made, and no reliance should be placed, expressively or impliedly, on the timeliness, accuracy or completeness of such data and information.