Africa CDC-Led MOSA Trial Begins Enrolling Patients to Evaluate Mpox Therapeutics
核心洞察
The MOSA trial, led by Africa CDC (搜索), has begun enrolling patients in the Democratic Republic of Congo to evaluate potential Mpox (搜索) therapeutics.
The trial will initially assess the safety and efficacy of brincidofovir, an antiviral drug from Emergent BioSolutions, against Mpox (搜索).
This pan-African randomized platform adaptive trial aims to address the urgent need for approved Mpox (搜索) treatments in Africa, where cases continue to rise.
The Africa Centres for Disease Control and Prevention (Africa CDC (搜索)) has initiated enrollment in the MpOx (搜索) Study (MOSA), a pan-African randomized platform adaptive trial designed to evaluate potential therapeutics for Mpox. The first patients have been enrolled at Mbandaka Hospital in the Democratic Republic of Congo (DRC), marking a crucial step in addressing the ongoing Mpox health threat in Africa.
Addressing an Urgent Need
Mpox (搜索), declared a Public Health Emergency of Continental Security by Africa CDC (搜索) on August 13, 2024, continues to pose a significant threat, particularly to vulnerable populations including women, children, and individuals living with HIV. Despite the pressing need, there are currently no approved therapeutics for Mpox in either the United States or Africa. Recent studies, such as PALM 007 and STOMP, have indicated that tecovirimat did not demonstrate the anticipated effect on lesion resolution, highlighting the necessity for alternative treatment options.
MOSA Trial Details
The MOSA trial will evaluate various antivirals, both alone and in combination, with an initial focus on brincidofovir, an antiviral developed by Emergent BioSolutions. Brincidofovir is currently available in the United States under a single-patient emergency use Investigational New Drug (IND) protocol for Mpox (搜索). However, its safety and efficacy in treating Mpox in humans have not yet been established through double-blind, placebo-controlled studies.
In the MOSA trial, participants will receive either brincidofovir or a matching placebo in a liquid oral formulation, administered once weekly for two weeks. A first interim analysis of the trial data is anticipated by the end of the first quarter of 2025.
Leadership and Collaboration
"Africa is not just responding to the Mpox (搜索) outbreak; we are leading the charge in finding solutions by spearheading research and development for Mpox therapeutics," stated Dr. Jean Kaseya, Director General of Africa CDC (搜索). "The MpOx Study represents a groundbreaking step toward developing a treatment. This effort goes beyond research--it's about African ownership and leadership in addressing our continent's health challenges through vital, innovative research."
The MOSA trial is sponsored by PANTHER (搜索), a key research partner of Africa CDC (搜索), and builds upon initial funding from the European Union's Horizon Europe program. The study protocol underwent review through the AVAREF collaborative process in 2023, ensuring adherence to the highest ethical and scientific standards. The study's design incorporates pre-planned interim analyses, allowing for rapid decision-making based on early signs of futility or success.
Study Population and Objectives
The MOSA trial aims to recruit both children and adults, with a focus on individuals at the highest risk of severe outcomes, particularly those in remote areas. As Mpox (搜索) cases continue to rise in Africa, especially in the DRC, the MOSA trial seeks to provide critical data on potential treatment options.
"We look forward to advancing MOSA, another critical research project that complements ongoing studies on transmission, vaccines and social sciences", said Prof Placide Mbala, Principal Investigator for the study in the DRC and Head of the Department of Epidemiology and Global Health at INRB.
"Mpox (搜索) continues to be a global threat to public health, creating a need for treatments and vaccines," said Simon Lowry, M.D., chief medical officer, head of research and development, Emergent. "We applaud Africa CDC (搜索) and PANTHER (搜索) for their work progressing the 'MpOx Study in Africa' (MOSA) and advancing research for brincidofovir."