MetrioPharm AG, a Swiss pharmaceutical company developing drugs for inflammatory diseases, has announced topline data from its CT05 phase IIa study of small molecule macrophage metabolic modulator MP1032 in COVID-19 patients.
In the trial, patients received either MP1032 plus standard of care (SoC), or placebo plus SoC.
SoC partially included other antivirals (Remdesivir or Nirmatrelvir/Ritonavir), which allowed to compare patient sub-groups who received one of four treatments. These were: both MP1032 plus antivirals; only MP1032 and no other antivirals; only other antivirals (Remdesivir or Nirmatrelvir/Ritonavir) but no MP1032; or neither MP1032 nor other antivirals at all.
All of these subgroups received additional SoC in form of supplemental oxygen, corticosteroids and other supportive therapy as medically indicated.
In line with WHO requirements and supported by a grant from the European Health Emergency Preparedness and Response Authority (HERA), the trial was designed as a phase IIa exploratory trial to evaluate the efficacy of antiviral drugs in hospitalized COVID-19 patients in addition to standard of care. Therefore, the overall add-on protective effect of all anti-viral drugs evaluated in this trial (MP1032, Remdesivir, Nirmatrelvir/Ritonavir) was limited.
The data demonstrate that monotherapy with MP1032 plus SoC was equally effective as monotherapy with Remdesivir or Nirmatrelvir/Ritonavir plus SoC, respectively – an effect that is expected to be significantly stronger when the compound is used in early-intervention or prevention in non-hospitalized patients.
MetrioPharm‘s MP1032 advantages over other anti-virals
MetrioPharm said MP1032 has advantages over other available antivirals: it can be administered orally and has both anti-inflammatory and anti-SARS-CoV-2 properties, making it an ideal candidate to prevent a so-called cytokine storm.
The compound has demonstrated an outstanding safety profile in several clinical trials without severe drug-related adverse events or potential for adverse drug-drug interactions. It is suitable for elderly and multi-morbid patients with a wide range of concomitant diseases and medications.
Also, while other antivirals target viral proteins and as such may become ineffective in future mutation variants of SARS-viruses, MP1032 is a host-directed anti-viral therapy (HDT), which makes it agnostic to any current or potential future corona viral mutations.
“MP1032 addresses several important previously unresolved medical challenges in the treatment of COVID-19,” said Wolfgang Brysch, CSO of MetrioPharm.
“It acts both as broad-spectrum anti-corona viral and anti-inflammatory compound and demonstrates an efficacy comparable to Remdesivir and Nirmatrelvir/Ritonavir. In contrast to those drugs MP1032 has the additional potential to be effective in pre- and post-exposure prophylaxis (PrEP, PEP). For PrEP there are still no orally available therapies and for PEP no approved drugs exist at all. Thus, MP1032 has the potential to meet the high unmet medical need for a safe, oral prophylactic and early intervention drug with respect to potential new SARS-CoV-2 variants and other future pandemic threats.”
Broader applicability
“We are very satisfied with the outcome of this study,” said Thomas Christély, CEO of MetrioPharm.
“As MP1032 can be applied earlier than other antivirals approved for COVID-19 and has an excellent safety and tolerability profile, we expect a much broader applicability. MP1032 may prevent hospitalization, shorten length of hospital stay, and – unlike Remdesivir – can be administered as a pill outside the hospital without difficulty. In addition to the application for prophylactic and early intervention, we are convinced of and will explore further the application of MP1032 for long COVID.”
About MetrioPharm‘s MP1032
MetrioPharm’s lead compound MP1032 is an orally administered immune metabolic modulator. The compound targets activated macrophages and acts via normalizing immune-cellular redox balance, which is essential for an optimal and coordinated host immune response to infections and (auto-)immune-inflammatory diseases.
MP1032 acts via a first-in-class self-regulated ROS- scavenging mechanism which is only triggered in over-activated immune cells. MP1032 does not alter the physiologic ROS concentrations of other cells which are essential e. g. for cell signaling.
This mechanism leads to an outstanding safety profile, specifically without any immunosuppressive side effects.
In addition to its anti-inflammatory effects, the compound has demonstrated host-mediated anti- viral properties against all variants of concern of SARS-CoV-2.
Besides SARS-CoV-2, the compound is being developed by MetrioPharm in various auto-immune disorders (psoriasis, multiple sclerosis, inflammatory bowel disease, and rheumatoid arthritis), in orphan and critical care indications.