MetrioPharm Announces Topline Data of its Phase IIa Study of MP1032 in COVID-19 Patients

• Orally administered MP1032 with very favorable safety and tolerability profile
• Compound equally effective as Remdesivir or Nirmatrelvir/Ritonavir as monotherapy
• Oral administration and suitability for early intervention address high unmet medical need

Zurich, December 8, 2022 – MetrioPharm AG, a pharmaceutical company developing drugs for inflammatory diseases, today announced topline data of its CT05 Phase IIa double-blind placebo-controlled 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 a) both MP1032 plus antivirals b) only MP1032 and no other antivirals, c) only other antivirals (Remdesivir or Nirmatrelvir/Ritonavir) but no MP1032 or d) 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. However, 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.

MP1032 has many advantages over other available antivirals: it can be conveniently 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. Moreover, 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 Dr. 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.”

“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.”

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About 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.

About MetrioPharm AG

MetrioPharm AG is a private, clinical-stage biotech company focused on therapies for inflammatory and infectious diseases.

MetrioPharm targets the modulation of immune metabolism with first-in-class self-regulating drug candidates. The Company´s platform has generated small-molecule metabolic modulators that have demonstrated pre-clinical and clinical efficacy in a wide range of inflammatory and infective diseases with an outstanding safety profile. Further opportunities of the technology lie in metabolic modulation of the tumor micro-environment which holds promise for enhancing the efficacy of immune-oncological therapies.

Based on this core technology, MetrioPharm has created a diversified pipeline of disease-specific drug combinations to target inflammatory, autoimmune, and degenerative diseases. Pre-clinical and clinical efficacy data have been obtained in multiple sclerosis, arthritis, sepsis, inflammatory bowel disease and psoriasis. The Company is currently also exploring orphan indications.

In a second line of development, the Company is developing its technology to target infectious diseases like COVID-19. Supported by a grant from the European Health Emergency Preparedness and Response Authority (HERA), a Phase IIa exploratory trial to evaluate the effect on hospitalized COVID-19 patients is ongoing.

The Company is headquartered in Zurich and has a subsidiary for R&D activities in Berlin.

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.

https://ec.europa.eu

The iMPact project was nominated for European Commission funding in July 2021, and the grant agreement was signed in November 2021.

Forward-looking statements

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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