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New Publication in Expert Review of Anti-infective Therapy Evaluates Brincidofovir as Potential Antiviral Treatment for Mpox

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Emergent BioSolutions (NYSE:EBS) announced the publication of a review article in Expert Review of Anti-infective Therapy evaluating brincidofovir as a potential treatment for mpox. The article examines brincidofovir's in vitro and in vivo data, human case studies, and its current evaluation in the Democratic Republic of Congo.

The publication comes amid ongoing global mpox outbreaks, with the WHO declaring a Public Health Emergency of International Concern (PHEIC) on August 14, 2024. Brincidofovir is being evaluated in the MpOx Study in Africa (MOSA), a double-blind, placebo-controlled clinical trial that began in January 2025, conducted in partnership with PANTHER and funded by Horizon Europe and Africa CDC.

Emergent BioSolutions (NYSE:EBS) ha annunciato la pubblicazione di un articolo di revisione su Expert Review of Anti-infective Therapy che valuta brincidofovir come possibile trattamento per il vaiolo delle scimmie (mpox). L'articolo analizza i dati in vitro e in vivo di brincidofovir, studi di casi umani e la sua attuale valutazione nella Repubblica Democratica del Congo.

La pubblicazione arriva in un contesto di focolai globali di mpox in corso, con l'OMS che ha dichiarato un'emergenza di sanità pubblica di interesse internazionale (PHEIC) il 14 agosto 2024. Brincidofovir è oggetto di valutazione nello studio MpOx in Africa (MOSA), uno studio clinico randomizzato, in doppio cieco e controllato con placebo iniziato a gennaio 2025, condotto in collaborazione con PANTHER e finanziato da Horizon Europe e Africa CDC.

Emergent BioSolutions (NYSE:EBS) anunció la publicación de un artículo de revisión en Expert Review of Anti-infective Therapy que evalúa brincidofovir como un tratamiento potencial para la viruela del mono (mpox). El artículo examina los datos in vitro e in vivo de brincidofovir, estudios de casos humanos y su evaluación actual en la República Democrática del Congo.

La publicación se produce en medio de brotes globales continuos de mpox, con la OMS declarando una Emergencia de Salud Pública de Importancia Internacional (PHEIC) el 14 de agosto de 2024. Brincidofovir está siendo evaluado en el Estudio MpOx en África (MOSA), un ensayo clínico aleatorizado, doble ciego y controlado con placebo que comenzó en enero de 2025, realizado en colaboración con PANTHER y financiado por Horizon Europe y Africa CDC.

Emergent BioSolutions (NYSE:EBS)Expert Review of Anti-infective Therapympox 치료 가능성으로서의 brincidofovir에 관한 리뷰 기사를 발표했다고 밝혔습니다. 이 글은 brincidofovir의 시험관 내 및 생체 내 데이터, 인간 사례 연구, 그리고 현재 콩고민주공화국에서의 평가를 다룹니다.

이 출판은 전 세계적으로 mpox 발병이 계속되는 가운데 이루어졌으며, 세계보건기구(WHO)가 2024년 8월 14일 국제적 공중보건 비상사태(PHEIC)를 선언했습니다. brincidofovir는 아프리카 MpOx 연구(MOSA)에서 평가 중이며, 이는 2025년 1월에 시작된 이중맹검 위약대조 임상시험으로, PANTHER와 협력하여 Horizon Europe과 Africa CDC의 자금 지원을 받고 있습니다.

Emergent BioSolutions (NYSE:EBS) a annoncé la publication d'un article de revue dans Expert Review of Anti-infective Therapy évaluant le brincidofovir comme traitement potentiel contre le mpox. L'article examine les données in vitro et in vivo du brincidofovir, des études de cas humaines ainsi que son évaluation actuelle en République démocratique du Congo.

Cette publication intervient alors que des épidémies mondiales de mpox sont en cours, avec l'OMS déclarant une urgence de santé publique de portée internationale (USPPI) le 14 août 2024. Le brincidofovir est évalué dans l'étude MpOx en Afrique (MOSA), un essai clinique randomisé en double aveugle contrôlé par placebo qui a débuté en janvier 2025, mené en partenariat avec PANTHER et financé par Horizon Europe et Africa CDC.

Emergent BioSolutions (NYSE:EBS) gab die Veröffentlichung eines Übersichtsartikels in Expert Review of Anti-infective Therapy bekannt, der Brincidofovir als potenzielle Behandlung von Mpox bewertet. Der Artikel untersucht die in vitro und in vivo Daten von Brincidofovir, Fallstudien am Menschen sowie die aktuelle Bewertung in der Demokratischen Republik Kongo.

Die Veröffentlichung erfolgt vor dem Hintergrund anhaltender globaler Mpox-Ausbrüche, wobei die WHO am 14. August 2024 den Ausbruch als Öffentliche Gesundheitsnotlage von internationaler Bedeutung (PHEIC) erklärte. Brincidofovir wird in der MpOx-Studie in Afrika (MOSA) bewertet, einer doppelblinden, placebokontrollierten klinischen Studie, die im Januar 2025 begann und in Partnerschaft mit PANTHER sowie finanziert von Horizon Europe und Africa CDC durchgeführt wird.

Positive
  • None.
Negative
  • No efficacy data or results available yet from the ongoing trial
  • Product still in investigational phase for mpox treatment

Insights

Emergent's brincidofovir shows potential against mpox amid global outbreak; ongoing trials may expand treatment options for this public health emergency.

The publication of this comprehensive review in Expert Review of Anti-infective Therapy represents a significant development in the search for effective mpox treatments. The timing is particularly relevant as mpox has triggered a second Public Health Emergency of International Concern (PHEIC) declaration by the WHO, highlighting the urgent need for therapeutic options.

Brincidofovir, marketed as TEMBEXA®, is an antiviral with established activity against orthopoxviruses. What makes this development noteworthy is that current treatment options for mpox remain limited. Tecovirimat (TPOXX) is currently the primary antiviral used, but having alternative or complementary treatments is crucial for several reasons:

  • The publication discusses the potential for combination therapy with tecovirimat for immunocompromised patients with severe disease, which could address treatment gaps for the most vulnerable populations
  • The ongoing MOSA trial (MpOx Study in Africa) represents a rigorous approach to generating clinical evidence, using a double-blind, placebo-controlled design
  • The involvement of Africa CDC and PANTHER indicates significant institutional support for this research direction

The scientific review appears to consolidate existing knowledge about brincidofovir for mpox, including in vitro data, in vivo studies, and human case reports. This comprehensive approach provides a foundation for further clinical investigation. From a medical perspective, having multiple treatment options is valuable for addressing viral resistance, contraindications, and optimizing patient outcomes across diverse populations including pediatric patients.

The ongoing evaluation in the Democratic Republic of Congo is particularly relevant as Central Africa remains an epicenter of the current outbreak. If successful, this could provide an important treatment option for regions most affected by the disease.

Ongoing mpox outbreak continues to be a global health threat and is driving need for greater therapeutic research and innovation

GAITHERSBURG, Md., July 28, 2025 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced the publication of a comprehensive review article, "Brincidofovir in the Era of Mpox," in the peer-reviewed journal Expert Review of Anti-infective Therapy.1 This publication includes an overview of brincidofovir, in vitro and in vivo data, including human case studies of the investigational use of brincidofovir, the current evaluation for treating mpox infections in adults and pediatrics in the Democratic Republic of Congo, and the potential for combination therapy with tecovirimat for immunocompromised patients with severe disease.    

“We believe in the importance of assessing brincidofovir, an antiviral, for this public health threat and we look forward to advancing our research across mpox as it’s a global disease of increasing concern,” said Simon Lowry, M.D., chief medical officer and head of research and development at Emergent.

Mpox, formerly known as monkeypox, continues to pose a significant public health challenge, with ongoing regional and global outbreaks particularly in Central and West Africa. On August 14, 2024, the World Health Organization (WHO) declared the current mpox outbreak a global Public Health Emergency of International Concern (PHEIC).2 This marks the second mpox PHEIC declared by the WHO in the past two years, which followed the regional emergency declaration by the Africa Centres for Disease Control and Prevention (Africa CDC) on August 13, 2024.3 This month, the U.S. Centers for Disease Control and Prevention issued an updated report on the surge of mpox around the world.4

As part of the ongoing effort to identify safe and effective treatments for mpox, brincidofovir is currently being evaluated by the Africa CDC in partnership with PANTHER (PANdemic preparedness plaTform for Health and Emerging infectious Response) in the MpOx Study in Africa (MOSA), a double-blind, placebo-controlled clinical trial for people diagnosed with mpox, which initiated in January 2025. The study has received initial funding from Horizon Europe and Africa CDC.

Dr. Lowry continued, “In addition to our engagement with PANTHER on the MOSA trial, this scientific review provides insights into the investigational use of brincidofovir in the treatment of mpox, and we are pleased this publication is available for the broader medical community.”

Please see full Prescribing Information for TEMBEXA® (brincidofovir) for additional safety information.

About Emergent BioSolutions 
At Emergent, our mission is to protect and save lives. For over 25 years, we’ve been at work preparing those entrusted with protecting public health. We deliver protective and life-saving solutions for health threats like smallpox, mpox, botulism, Ebola, anthrax and opioid overdose emergencies. To learn more about how we help prepare communities around the world for today’s health challenges and tomorrow’s threats, visit our website and follow us on LinkedInXInstagramApple Podcasts and Spotify

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We generally identify forward-looking statements by using words like “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “should,” “will,” “would,” and similar expressions or variations thereof, or the negative thereof, but these terms are not the exclusive means of identifying such statements. Forward-looking statements are based on our current intentions, beliefs, and expectations regarding future events based on information that is currently available. We cannot guarantee that any forward-looking statement will be accurate.

Readers should realize that if underlying assumptions prove inaccurate or if known or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Readers are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events, or circumstances.

Readers should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the U.S. Securities and Exchange Commission, when evaluating our forward-looking statements.

Investor Contact:
Richard S. Lindahl
Executive Vice President, CFO
lindahlr@ebsi.com

Media Contact:
Assal Hellmer
Vice President, Communications
mediarelations@ebsi.com

__________________________

1 https://doi.org/10.1080/14787210.2025.2532029
2 https://www.who.int/news/item/14-08-2024-who-director-general-declares-mpox-outbreak-a-public-health-emergency-of-international-concern
3 https://africacdc.org/news-item/africa-cdc-declares-mpox-a-public-health-emergency-of-continental-security-mobilizing-resources-across-the-continent/
4 https://www.cdc.gov/mpox/situation-summary/index.html


FAQ

What is Emergent BioSolutions (EBS) evaluating brincidofovir for?

Emergent BioSolutions is evaluating brincidofovir as a potential antiviral treatment for mpox infections in adults and pediatrics, particularly in the Democratic Republic of Congo.

When did the MOSA clinical trial for EBS's brincidofovir begin?

The MpOx Study in Africa (MOSA), a double-blind, placebo-controlled clinical trial, initiated in January 2025.

Who is funding the EBS brincidofovir mpox study?

The study has received initial funding from Horizon Europe and Africa CDC.

What type of study is being conducted for brincidofovir in mpox treatment?

A double-blind, placebo-controlled clinical trial called MOSA (MpOx Study in Africa) is being conducted to evaluate brincidofovir's effectiveness in treating mpox.

When did WHO declare mpox as a Public Health Emergency?

The World Health Organization (WHO) declared mpox a global Public Health Emergency of International Concern (PHEIC) on August 14, 2024.
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