Brincidofovir

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 | PANTHEREmail: Media@pantherhealth.orgWebsite: www.pantherhealth.orgTwitter | 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

PANTHER to conduct clinical trial under the leadership of Africa Centres for Disease Control and Prevention GAITHERSBURG, Md., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced that brincidofovir (brand name TEMBEXA®) will be included in a clinical trial conducted and sponsored by PANTHER, under the leadership of the Africa Centres for Disease Control and Prevention (Africa CDC), as part of the ‘MpOx Study in Africa’ (MOSA). The study will evaluate the safety and efficacy of brincidofovir in treating mpox virus in a randomized double-blind placebo-controlled trial. “We applaud Africa CDC and PANTHER for the launch of the ‘MpOx Study in Africa’ (MOSA), an important step in advancing research for brincidofovir, and are proud to support the trial with our brincidofovir antiviral treatment,” said Joe Papa, president and CEO, Emergent BioSolutions. “Emergent is committed to working with partners around the world to study and produce vaccines and treatments to address all orthopoxviruses, including mpox and smallpox.” Brincidofovir is an antiviral medical countermeasure that is part of Emergent’s product portfolio. There are currently no therapeutics approved by the FDA to treat patients infected by mpox virus who are at risk of severe complications. While brincidofovir treatment is available to be used for mpox in the U.S. under emergency Investigational New Drug protocol, it has not yet been evaluated in any randomized double-blind placebo-controlled studies for mpox. On August 13, Africa CDC declared mpox a public health emergency of continental security, which was followed by a statement from World Health Organization’s Director-General declaring that the upsurge of mpox in the DRC and a growing number of countries in Africa constitutes a public health emergency of international concern under the International Health Regulations (2005). About the clinical trial: The study MOSA (MpOx Study in Africa) is a pan-African, double-blind, platform adaptive trial assessing treatments for patients diagnosed with mpox virus. Inclusion criteria are children, adults with mucosal lesions or PLWHIV. It is sponsored by PANTHER 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. The trial is scheduled to begin in the coming weeks in the Democratic Republic of Congo and neighboring countries. Please read full Prescribing Information for TEMBEXA® for additional safety information here. About Emergent BioSolutions At Emergent, our mission is to protect and enhance life. For 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. Safe Harbor Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including statements regarding the any future procurements to supply brincidofovir (brand name TEMBEXA®), are forward-looking statements. 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 Emergent’s current intentions, beliefs, and expectations regarding future events. Emergent cannot guarantee that any forward-looking statement will be accurate. Readers should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Emergent’s 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, Emergent does not undertake to update any forward-looking statement to reflect new information, events or circumstances. There are a number of important factors that could cause Emergent’s actual results to differ materially from those indicated by any forward-looking statements. Readers should consider this cautionary statement, as well as the risk factors identified in Emergent’s periodic reports filed with the U.S. Securities and Exchange Commission when evaluating Emergent’s 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