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iMPact

Financiado

Novel, orally available immune modulator MP1032 with anti-SARS-CoV-2 and anti-cy...

Novel, orally available immune modulator MP1032 with anti-SARS-CoV-2 and anti-cytokine activity The current global COVID-19 pandemic has caused severe health and socio-economic challenges. Despite significant improvements in the treatment of critical COVID-19 patients and advances in vaccine development, there is still an ur... ver más

30/04/2023

METRIOPHARM AG

8M€

Presupuesto del proyecto: 8M€

Líder del proyecto

METRIOPHARM AG No se ha especificado una descripción o un objeto social para esta compañía.

Ver 6 Participantes

Financiación concedida El organismo HORIZON EUROPE notifico la concesión del proyecto el día 2023-04-30

HORIZON-HLTH-2021-CORONA-01-01: Vaccines & therapeutic clinical tri... Expected Outcome:This topic aims at supporting activities that enable the conduct of vaccine & t...

I+D

Cerrada hace 3 años

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6 Participantes

METRIOPHARM AG

7.65M€ | Lider

IMMUNOLOGIK GMBH

146.67K€ | Participante

Catalyze B.V.

159.06K€ | Participante

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Duración del proyecto: 17 meses Fecha Inicio: 2021-11-16
Fecha Fin: 2023-04-30

Líder del proyecto

METRIOPHARM AG No se ha especificado una descripción o un objeto social para esta compañía.

Presupuesto del proyecto 8M€

Descripción del proyecto The current global COVID-19 pandemic has caused severe health and socio-economic challenges. Despite significant improvements in the treatment of critical COVID-19 patients and advances in vaccine development, there is still an urgent need for safe and effective early-intervention treatments. To reduce disease burden, hospitalization time, and mortality, it is of critical importance to halt disease progression in early (mild-to-moderate) stages. Our new drug, MP1032, has a dual mode of action, targeting two important mechanisms (immune system overactivation and viral replication) in the early development of COVID-19. Its unique mechanism of self-regulation prevents immune-suppression, which is critical for early intervention. In combination with the oral availability, favourable safety profile, rapid and affordable production scale-up, and potential to work against viral variants, MP1032 is the ideal candidate for early treatment of COVID-19, which can also be used safely in high-risk patients. Therefore, the iMPact project aims to clinically validate MP1032 in a Phase II trial for its ability to stop COVID-19 disease progression. The outcome of the project shall serve as a basis for follow-up rapid Phase IIb/III development and market registration. Four international SME’s will work together in the iMPact project to achieve the objectives: 1) To demonstrate the efficacy of MP-1032 in hospitalized COVID-19 patients, 2) To demonstrate the effect of MP1032 on current SARS-CoV-2 variants, 3) To develop a GMP-compliant production scale-up process for MP1032, 4) To ensure that the clinical development plan is in line with regulatory requirements and 5) To collaborate with existing EU research networks. We have 29 clinical sites on board, and the required expertise for upscaling GMP manufacturing and regulatory preparation is available, ensuring that, by October 2022, MP1032 will be ready to progress to Phase IIb/III trials.

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