Background

The current global pandemic caused by SARS-CoV-2 has created severe health and socio-economic challenges in almost all countries around the world. Early intervention in COVID-19 can prevent severe disease stages and mortality.

In order to reduce disease burden, shorten hospitalisation time, prevent mortality and unburden healthcare systems, it is of critical importance to halt disease progression of COVID-19 in early stages. Anti-viral drugs that have gained recent emergency authorization need to be administered in a narrow time-window after an infection to be effective. Such a drug should also be effective against new, emerging viral mutants.

Aim

The iMPact project aims to demonstrate that the asset MP1032 is a promising new candidate for the early intervention treatment of COVID-19 patients. MP1032 is a first-in-class drug candidate that targets cellular oxidative stress and thereby reduces inflammatory markers such as TNF-alpha, IL-6, IL-12 which makes it highly promising for early intervention treatment of COVID-19. MP1032 is a compound with several unique advantages:

  1. A dual mode of action (both immune modulating and anti-viral replication) that addresses the key disease mechanisms of the early stages of COVID-19 and therefore may prevent disease progression to severe stages
  2. A unique mechanism of self-regulation ensures that the immune system is not suppressed and can keep working to fight off the virus and eventual consequences of the infection
  3. The excellent safety profile provides an opportunity to use in high-risk patients
  4. The anti-viral activity has a high probability to be effective in all current and potential future viral variants, both within SARS-CoV-2 and other future SARS viruses
  5. The drug has a potential to treat ‘long-COVID’ and could be used as a prophylactic treatment after initial approval for first line early intervention

Approach

The overall approach of the iMPact project has been split into five clear work packages, which are based on the objectives of the iMPact project:

Objective: Demonstrate the efficacy of MP1032 in hospitalised COVID-19 patients

  • 40 sites worldwide and approximately 140 patients will participate in this study, consisting of three periods: 1) screening 2) treatment 3) follow-up
  • Primary efficacy endpoint of this study: the proportion of patients with disease progression on day 14. Disease progression is defined as the proportion of patients who are not alive or who have respiratory failure.

Objective: demonstrate the effect of MP1032 on current SARS-CoV-2 variants

  • Anti-viral activity of the drug will be tested against different SARS-CoV-2 mutants (alpha, beta, gamma, delta variants).
  • Mode of action studies of MP1032.
  • The anti-viral efficacy of MP1032 will also be tested against the SARS-1 and MERS coronavirus strains to assess potential efficacy against future SARS epidemics involving new strains

Objective: develop a GMP-compliant production scale-up process for MP1032 API

  • Upscaling process, enabling100kg per batch shall be developed

Objective: ensure that the clinical development plan is in line with regulatory requirements

  • Seek near-term regulatory input from EMA in form of a scientific advice
  • Regulatory development plan for the expansion of use to children and pregnant women will be created, including a Paediatric Investigation Plan (PIP)

Objective: Collaborate with existing European Research Infrastructures and trial networks

  • Establish contact with the Coordination of European COVID-19 Adaptive Platform Trials, as part of the RECOVER EUROPE initiative
  • Seek to join the EU-RESPONSE initiative in order to conduct follow-up Phase III studies within the network

Not linked to a specific objective but instead a focus on overall coordination to ensure all project objectives are met

  • This WP includes project management, risk management, financial coordination, IP management and reporting to and communicating with the EC
  •  (PIP)