Work will accelerate drug development and testing
The development of a medication to treat illness from Ebola will be accelerated under a contract with the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR). This contract supports the government-wide response to the Ebola outbreak in West Africa.
ASPR's Biomedical Advanced Research and Development Authority (BARDA) will provide funding as well as access to subject matter expertise and technical support for manufacturing, regulatory, and nonclinical activities through a $24.9 million, 18-month contract with Mapp Biopharmaceutical Inc., of San Diego, California. ASPR can extend the contract up to a total of $42.3 million.
Work under the contract supports the development and manufacturing of the medication ZMapp toward the goal of U.S. Food and Drug Administration approval.
"While ZMapp has received a lot of attention, it is one of several treatments under development for Ebola, and we still have very limited data on its safety and efficacy," explained Dr. Nicole Lurie, assistant secretary for preparedness and response. "Developing drugs and vaccines to protect against Ebola as a biological threat has been a long-term goal of the U.S. government, and today's agreement represents an important step forward."
The Defense Threat Reduction Agency (DTRA) within the Department of Defense and the National Institute of Allergy and Infectious Diseases (NIAID) of HHS' National Institutes of Health supported initial work on this product. To speed the development of ZMapp, BARDA will work closely with those agencies. BARDA also will work with the company to optimize and accelerate the manufacturing of ZMapp so testing can be done as soon as possible.
As part of the project funded today, Mapp Biopharmaceutical will manufacture a small amount of the drug for early stage clinical safety studies and nonclinical studies needed to demonstrate the drug's safety and efficacy in people. Mapp Biopharmaceuticals also will work with BARDA on the manufacturing process, increasing production yields and the scale of manufacturing.
As an experimental drug, ZMapp currently is available only in very limited quantities and these steps will contribute to increasing the amount of product potentially available to treat patients with Ebola.
ZMapp is a combination of three monoclonal antibodies manufactured in tobacco plants. Monoclonal antibodies bind certain virus proteins and neutralize the virus, decreasing the amount of the virus in the body that the patient's immune system has to fight. ZMapp has been shown to reduce mortality in mice and nonhuman primates exposed to Ebola viruses.
The project with Mapp Biopharmaceutical is the first BARDA program supporting the development of a product against viruses that cause viral hemorrhagic fever.
Even the most advanced potential therapeutics and vaccines for Ebola are entering early clinical trials. BARDA is working with other federal agencies to accelerate the development of Ebola therapeutics and vaccines and to identify ways to optimize and expand their production. BARDA is exploring whether its Centers for Innovation in Advanced Development and Manufacturing, its Fill Finish Manufacturing Network, or other measures can accelerate the manufacturing time.
BARDA is seeking additional proposals for the advanced development of antibody treatments, antiviral drugs, and vaccines against the Ebola and Marburg viruses, both of which cause viral hemorrhagic fever. Program requirements are described in BARDA's Broad Agency Announcement BARDA-BAA-13-100-SOL-00013 at https://www.fbo.gov.
HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. The Office of the Assistant Secretary for Preparedness and Response (ASPR) leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities' ability to withstand adversity, strengthening health and response systems, and enhancing national health security.
Within ASPR, the Biomedical Advanced Research and Development Authority (BARDA) develops and procures medical countermeasures – vaccines, medicines, diagnostics and medical equipment – that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases.