MPX-RESPONSE

aims to increase the knowledge of mpox, to evaluate potential treatments, and to strengthen Europe’s global preparedness for emerging infectious disease outbreaks.

In May 2022,  a major global outbreak of mpox (Clade IIb) began in Europe and quickly spread worldwide. While cases outside Africa dropped by the end of summer 2022, they continue to be reported globally, illustrating continuing transmission of mpox across the world. The Democratic Republic of Congo (DRC) and nearby countries are also seeing high numbers of cases, along with a new clade of the virus. This led the WHO to re-declare mpox a Public Health Emergency of International Concern (PHEIC) in August 2024. Ongoing surveillance is essential, as the risk of new outbreaks remains. Understanding the disease better will help improve treatment and prevent another global health crisis.

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Key Points

SYMPTOMS
Acute skin rash or mucosal lesions

DEATH RATE
1 to 10 %
depending on the strain

TRANSMISSION
Humans to humans through physical contact or through infected animals

ENDEMIC AREAS
Africa, especially Sub-Saharan region

GLOBAL OUTBREAK
2022-2023

TREATMENT
No systematically evaluated treatment yet

Challenges

A lack of cases leading to a limited research

Due to the scarcity of cases worldwide before the 2022 outbreak and neglect of the mpox burden in low-and middle-income countries, research efforts have been fragmented and the disease, despite its clinical significance, remains relatively unknown. The lack of comprehensive understanding regarding its clinical characteristics has further hindered progress in developing effective treatments and preventive measures.

MPX-RESPONSE
Aims at improving our understanding of clinical and virological outcomes in patients with Mpox disease, for example through an observational cohort (MOSAIC).

A need for curative treatments validated through comprehensive and rigorous testing protocols

Some antivirals have demonstrated activity in animal models. Tecovirimat SIGA emerging as the most promising. In 2022, this oral antiviral drug received marketing authorization from the European Medicines Agency (EMA) under exceptional circumstances. However, tecovirimat has yet to undergo evaluation in a randomized controlled double-blind manner in patients.

MPX-RESPONSE
3 trials, based on the WHO CORE protocol evaluate the safety and efficacy of Tecovirimat SIGA in humans through rigorous controlled studies.

International collaboration through platform trials

As learned during the Covid-19 pandemic, effective collaboration is crucial not only within existing European networks but also on an international scale. This is particularly relevant in the case of epidemic outbreaks, where the number of cases can vary rapidly across regions of the world. Hence, adopting a global perspective proves more efficient than a regional one to prepare and respond to infectious diseases.

MPX-RESPONSE
Global governance for multi-country trials, with shared services such as common data management, shared statistical analysis and pharmacovigilance, to produce more robust data through collaboration.

Ambition

In collaboration with the WHO, MPX-RESPONSE will build on the experience of existing networks and the expertise of international platforms. The project goes beyond the scientific state-of-the-art and enhances Europe’s capacity to provide a rapid international response to a global epidemic such as the mpox international outbreak observed in 2022-23.

The three clinical trials set up through MPX-RESPONSE and the supporting management activities are ambitious and innovative:

  • Collaboratively collect data and evidence for better understanding of the disease
  • Evaluate optimal treatment against mpox infection and improve clinical management of patients
  • Strengthen Europe’s capacity to respond rapidly to public health emergencies
  • Broaden geographic scope through international trials that can produce robust data and avoid duplication of investigations
  • Innovate with international platform trials allowing to flexibly evaluate emerging treatments against infectious diseases

EPOXI

Phase III multi-country randomized, placebo-controlled, double-blinded trial to evaluate the safety and efficacy of Tecovirimat SIGA for the treatment of adult patients with mpox disease.

Coordinated by Ecraid and with UMCU as scientific sponsor
Geographical coverage: Europe

MOSA

Phase III, multi-country, randomized, placebo-controlled, double-blinded platform trial to assess the efficacy and safety of treatments against mpox in mpox endemic regions.

Coordinated and sponsored by PANTHER
Geographical coverage: Sub-Saharan African countries (endemic mpox regions)

UNITY

A phase III, multi-country, randomized, placebo-controlled, double-blinded trial to evaluate the safety and efficacy of Tecovirimat SIGA for the treatment of adult patients with mpox virus disease.

Coordinated and sponsored by ANRS MIE
Geographical coverage: International (Argentina, Brazil, Switzerland)