Enrollment Starts in Africa CDC-Led MpOx Therapeutic Study (MOSA)
Africa CDC has initiated patient enrollment in the MOSA trial, a pan-African randomized platform adaptive study for Mpox treatment at Mbandaka Hospital in DRC. The study, primarily evaluating brincidofovir, comes as Mpox remains a significant health threat across Africa, particularly affecting vulnerable populations.
The trial follows recent studies (PALM 007 and STOMP) showing tecovirimat's effectiveness in lesion resolution. MOSA will assess different antivirals' safety and efficacy, starting with brincidofovir, an antiviral from Emergent BioSolutions currently available in the US under emergency use IND for Mpox.
The study protocol includes a two-week treatment period with either brincidofovir or placebo in liquid oral form, administered weekly. The first interim analysis is expected by Q1 2025. The trial, sponsored by PANTHER and initially funded by EU's Horizon Europe program, will recruit both children and adults, focusing on those at highest risk of severe outcomes.
L'Africa CDC ha avviato l'arruolamento dei pazienti nello studio MOSA, una sperimentazione adattiva randomizzata pan-africana per il trattamento di Mpox presso l'ospedale di Mbandaka nella RDC. Lo studio, che valuta principalmente il brincidofovir, arriva mentre Mpox continua a rappresentare una significativa minaccia per la salute in tutta l'Africa, colpendo particolarmente le popolazioni vulnerabili.
La sperimentazione segue studi recenti (PALM 007 e STOMP) che mostrano l'efficacia del tecovirimat nella risoluzione delle lesioni. MOSA valuterà la sicurezza e l'efficacia di diversi antivirali, iniziando con il brincidofovir, un antivirale di Emergent BioSolutions attualmente disponibile negli Stati Uniti con un uso emergenziale IND per Mpox.
Il protocollo dello studio prevede un periodo di trattamento di due settimane con entweder brincidofovir o placebo in forma liquida orale, somministrato settimanalmente. La prima analisi intermedia è prevista entro il primo trimestre del 2025. La sperimentazione, sponsorizzata da PANTHER e inizialmente finanziata dal programma Horizon Europe dell'UE, recluterà sia bambini che adulti, concentrandosi su coloro che sono a maggior rischio di gravi esiti.
Africa CDC ha iniciado el reclutamiento de pacientes en el ensayo MOSA, un estudio adaptativo randomizado pan-africano para el tratamiento de Mpox en el Hospital de Mbandaka en la RDC. El estudio, que evalúa principalmente el brincidofovir, llega en un momento en que Mpox sigue siendo una amenaza significativa para la salud en África, afectando particularmente a las poblaciones vulnerables.
El ensayo sigue estudios recientes (PALM 007 y STOMP) que muestran la eficacia del tecovirimat en la resolución de lesiones. MOSA evaluará la seguridad y eficacia de diferentes antivirales, comenzando con el brincidofovir, un antiviral de Emergent BioSolutions actualmente disponible en los EE. UU. bajo uso de emergencia IND para Mpox.
El protocolo del estudio incluye un período de tratamiento de dos semanas con ya sea brincidofovir o placebo en forma líquida oral, administrado semanalmente. Se espera que el primer análisis interino se realice en el primer trimestre de 2025. El ensayo, patrocinado por PANTHER y financiado inicialmente por el programa Horizon Europe de la UE, reclutará tanto a niños como a adultos, centrándose en aquellos con mayor riesgo de resultados graves.
아프리카 CDC는 DRC의 Mbandaka 병원에서 Mpox 치료를 위한 범아프리카 무작위 플랫폼 적응 연구인 MOSA 시험에 환자 등록을 시작했습니다. 이 연구는 주로 브린시도포비르의 효과를 평가하며, Mpox는 아프리카 전역에서 여전히 중요한 건강 위협으로, 특히 취약한 인구에 영향을 미치고 있습니다.
이 시험은 최근의 연구(PALM 007 및 STOMP)를 따른 것으로, 이는 병변 해결에 대한 테코비리마트의 효능을 보여줍니다. MOSA는 브린시도포비르부터 시작하여 다양한 항바이러스제의 안전성과 효능을 평가할 것입니다. 브린시도포비르는 Emergent BioSolutions의 항바이러스제로 현재 미국에서 Mpox에 대해 긴급 사용 IND로 제공됩니다.
연구 프로토콜에는 2주 치료 기간이 포함되어 있으며, 브린시도포비르 또는 위약을 액체 경구 형태로 주간 투여합니다. 첫 번째 중간 분석은 2025년 1분기 중에 예상됩니다. PANTHER가 후원하고 EU의 Horizon Europe 프로그램으로 초기 자금을 지원받은 이 시험은 아동과 성인을 모두 모집하며, 심각한 결과 위험이 가장 높은 사람들에 중점을 두고 있습니다.
Africa CDC a lancé l'enregistrement des patients dans l'essai MOSA, une étude adaptative randomisée pan-africaine pour le traitement de Mpox à l'hôpital de Mbandaka en RDC. L'étude, qui évalue principalement le brincidofovir, intervient alors que Mpox reste une menace sanitaire importante à travers l'Afrique, touchant particulièrement les populations vulnérables.
L'essai suit des études récentes (PALM 007 et STOMP) montrant l'efficacité du tecovirimat dans la résolution des lésions. MOSA évaluera la sécurité et l'efficacité de différents antiviraux, en commençant par le brincidofovir, un antiviral d'Emergent BioSolutions actuellement disponible aux États-Unis dans le cadre d'un usage d'urgence IND pour Mpox.
Le protocole de l'étude comprend une durée de traitement de deux semaines avec soit du brincidofovir, soit un placebo sous forme liquide orale, administré chaque semaine. La première analyse interim est prévue pour le premier trimestre 2025. L'essai, parrainé par PANTHER et initialement financé par le programme Horizon Europe de l'UE, recrutera à la fois des enfants et des adultes, en se concentrant sur ceux qui présentent le plus grand risque de conséquences graves.
Africa CDC hat die Patientenaufnahme in die MOSA-Studie initiiert, eine pan-afrikanische randomisierte adaptive Plattformstudie zur Mpox-Behandlung im Krankenhaus von Mbandaka in der DRK. Die Studie bewertet hauptsächlich Brincidofovir, während Mpox weiterhin eine erhebliche Gesundheitsbedrohung in Afrika darstellt, insbesondere für gefährdete Bevölkerungsgruppen.
Die Studie folgt auf jüngste Studien (PALM 007 und STOMP), die die Wirksamkeit von Tecovirimat bei der Resolutio von Läsionen zeigen. MOSA wird die Sicherheit und Wirksamkeit verschiedener Antivirale bewerten, beginnend mit Brincidofovir, einem Antiviral von Emergent BioSolutions, das derzeit in den USA unter einem Notfallgebrauch-IND für Mpox verfügbar ist.
Das Studienprotokoll umfasst einen zweiwöchigen Behandlungszeitraum mit entweder Brincidofovir oder Placebo in flüssiger oraler Form, das wöchentlich verabreicht wird. Die erste Zwischenanalyse wird für das erste Quartal 2025 erwartet. Die Studie, die von PANTHER gesponsert und ursprünglich vom Horizon Europe-Programm der EU finanziert wurde, wird sowohl Kinder als auch Erwachsene rekrutieren und sich auf diejenigen konzentrieren, die das höchste Risiko für schwerwiegende Ergebnisse haben.
- First pan-African clinical trial for Mpox treatment initiated
- First interim analysis expected by end of Q1 2025
- Study includes both adult and pediatric populations
- Innovative study design with pre-planned interim analyses for rapid decision-making
- Previous Mpox treatment (tecovirimat) showed effectiveness in recent studies
- No therapeutic currently approved for Mpox treatment in US or Africa
- Safety and efficacy of brincidofovir for Mpox not yet established in controlled studies
Insights
The initiation of the MOSA trial represents a significant clinical development for Emergent BioSolutions' brincidofovir. Several critical aspects warrant attention:
The study's timing is particularly relevant given the recent disappointing results from tecovirimat in the PALM 007 and STOMP trials. This creates a substantial market opportunity for brincidofovir if successful. The trial's adaptive platform design with pre-planned interim analyses by Q1 2025 could accelerate the path to potential approval.
The strategic positioning in Africa, where Mpox remains endemic and was declared a Continental Security Emergency, provides access to a relevant patient population and positions Emergent BioSolutions favorably in an important market. The focus on vulnerable populations (women, children, HIV-positive individuals) could expand the drug's potential market reach.
However, investors should note that brincidofovir's efficacy against Mpox remains unproven in controlled studies. The current U.S. availability under emergency IND status indicates significant regulatory hurdles ahead. The once-weekly dosing regimen, if proven effective, could provide a competitive advantage over existing treatments.
From a market perspective, this trial launch carries several strategic implications:
The market opportunity is substantial given the absence of approved Mpox therapeutics in both the U.S. and Africa. The failure of tecovirimat in recent trials has created a significant void in the treatment landscape, potentially benefiting Emergent BioSolutions if brincidofovir shows positive results.
The collaboration with Africa CDC and pan-African research institutions provides valuable market access and positions EBS strategically in emerging markets. This could be particularly valuable as Mpox cases continue to rise in Africa and new variants emerge globally.
However, EBS's relatively small market cap of
ADDIS ABABA, Ethiopia and KINSHASA, Democratic Republic of the Congo and WASHINGTON and PARIS, Jan. 16, 2025 (GLOBE NEWSWIRE) -- Africa CDC’s support for the MOSA, a pan-African randomized platform adaptive trial for the MpOx Study, adding to the initial EU funding, has enabled the enrollment of the first patients at Mbandaka Hospital in Equateur Province, Democratic Republic of Congo (DRC). These patients have been randomized in this pivotal clinical trial, marking a critical step in addressing the Mpox health threat. As Clade Ib cases emerge outside Africa and Clade I and II cases continue to be reported across the continent, Africa CDC, INRB, and PANTHER are leading efforts to test promising therapeutic options to combat this persistent health threat.
Declared a Public Health Emergency of Continental Security on August 13, 2024, Mpox remains a significant health threat across Africa, particularly among vulnerable populations such as women, children, and individuals living with HIV. Despite the pressing need, no therapeutic has been approved to treat Mpox in the United States or Africa. Recent results from the PALM 007 and STOMP studies showed that tecovirimat did not show the expected effect on lesion resolution, underscoring the need for additional therapeutic options.
The MOSA trial demonstrates Africa’s leadership in addressing this urgent healthcare gap. The study will evaluate different antivirals, either alone or in combination. It will start by evaluating the safety and efficacy of brincidofovir. Brincidofovir is an antiviral from the global life sciences company Emergent BioSolutions. In the United States it is available under a single-patient emergency use Investigational New Drug (IND) for Mpox. The safety and efficacy of brincidofovir to treat Mpox in humans has not been established in double-blind, placebo-controlled studies for Mpox. In the MpOx Study, patients will receive either brincidofovir or a matching placebo in a liquid oral formulation, administered once-a-week, for 2 weeks.
A first interim analysis is expected by the end of Q1 2025.
“Africa is not just responding to the Mpox outbreak; we are leading the charge in finding solutions by spearheading research and development for Mpox therapeutics,” said Africa CDC Director General, Dr. Jean Kaseya. “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.”
Sponsored by PANTHER, a key research partner of Africa CDC, the MOSA trial builds upon initial funding provided by the European Union’s Horizon Europe program. The study protocol was reviewed through the AVAREF collaborative process in 2023, ensuring it meets the highest ethical and scientific standards. The innovative study design includes pre-planned interim analyses, allowing for rapid decision-making should early signs of either futility or success be observed.
“This milestone highlights the vital role of research preparedness and response. Funded initially by Horizon Europe as part of the emergency response to the mpox outbreak in 2022, I am delighted to see MOSA trial fully operational now to advance treatments for mpox.” Marc Lemaître, European Commission, Director-General for Research and Innovation.
“We are proud of this important milestone illustrating PANTHER’s mission in addressing continental epidemic priorities,” said Prof. Samba Ousmane Sow, Director General of the Centre for Vaccine Development in Mali (CVD-Mali) and President of the Board of PANTHER. “We hope to contribute to Africa CDC’s response to the current crisis while also deriving concrete lessons to better prepare for future ones.”
As Africa continues to report rising Mpox cases, particularly in the DRC, the MOSA trial seeks to provide critical data on potential treatment options. The study will recruit both children and adults, focusing on those most at risk of severe outcomes, especially in remote areas.
“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 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 and PANTHER for their work progressing the ‘MpOx Study in Africa’ (MOSA) and advancing research for brincidofovir.”
The U.S. FDA Prescribing Information for TEMBEXA® (brincidofovir) is provided for additional safety information here.
About the Pandemic Preparedness Platform for Health and Emerging Infections Response (PANTHER)
PANTHER is the first African-led pandemic preparedness platform for health and emerging infection response. Bringing together leading African and global researchers and public health teams, it aims to create regional hubs and clinical research platforms to support preparedness and rapid response to emerging infectious diseases globally, particularly in Africa.
For more information, visit https://pantherhealth.org.
PANTHER is sponsoring MOSA as part of the MPX-RESPONSE Project that has received funding from the European Union’s Horizon Europe Research and Innovation programme under grant agreement 101115188
About Africa Centres for Disease Control and Prevention (Africa CDC)
The Africa Centres for Disease Control and Prevention (Africa CDC) is a public health agency of the African Union. It is autonomous and supports member states in strengthening health systems. It also helps improve disease surveillance, emergency response, and disease control.
Learn more at: http://www.africacdc.org and connect with us on LinkedIn, Twitter, Facebook and YouTube.
About Emergent BioSolutions
At Emergent, our mission is to protect and enhance life. For over 25 years, we’ve been at work defending people from things we hope will never happen—so we are prepared just in case they ever do. We provide solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that we develop and manufacture for governments and consumers. We also offer a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers. To learn more about how we help protect public health, visit our website and follow us on LinkedIn, X, Instagram, Apple Podcasts and Spotify.
Media Contacts:
Margaret Edwin | Director of Communication and Public Information | Africa CDC EdwinM@africacdc.org
Jessica Ilunga | Communication Officer | PANTHER
Email: Media@pantherhealth.org
Website: www.pantherhealth.org
Twitter | LinkedIn
Assal Hellmer | Vice President, Communications | Emergent BioSolutions
Email: mediarelations@ebsi.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/683aea7c-60d3-4af9-8964-1d0031f84727
FAQ
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