|Ebola virus under an electron microscope--Courtesy of CDC|
Tiny biotech Mapp Biopharmaceutical made global headlines this summer when its early-stage Ebola treatment helped rescue a few patients from the deadly virus, and now the U.S. government is ponying up funds to help the company get its drug into clinical trials.
The Biomedical Advanced Research and Development Authority (BARDA) has signed an 18-month deal to provide Mapp with $24.9 million and accelerate the development and manufacturing of ZMapp, an investigational Ebola drug. BARDA, a division of Health and Human Services, has the option to extend the contract to $42.3 million in total, promising the biotech access to subject matter experts and technical support.
The goal is to get Mapp's candidate into its first human trials and confirm the promise it has shown in preclinical animal studies and use among healthcare workers who contracted Ebola while working to stem its outbreak in West Africa. Five of the 7 people treated with ZMapp survived their infections, and the drug charted a 100% success rate in a small primate trial disclosed last week, stoking hopes that it can make a difference in a public health crisis that has claimed more than 1,500 lives since March, according to the World Health Organization.
But, as HHS cautions, 5 patients and some positive preclinical results hardly serve as confirmation for ZMapp, and it's going to take a lot of work to get the antibody candidate through clinical trials and past the FDA.
"While ZMapp has received a lot of attention, it is one of several treatments under development for Ebola, and we still have very limited data on its safety and efficacy," HHS Assistant Secretary for Preparedness and Response Nicole Lurie said in a statement. "Developing drugs and vaccines to protect against Ebola as a biological threat has been a long-term goal of the U.S. government, and today's agreement represents an important step forward."
Meanwhile, the global R&D push for Ebola treatments presses on, with the National Institutes of Health expected to begin human trials on a GlaxoSmithKline ($GSK) vaccine this week. Tekmira ($TKMR) has renewed hope for its treatment for the virus after the FDA walked back a full clinical hold earlier this month, and the RNAi therapeutic has charted positive results against Marburg, a viral cousin to Ebola. Separately, drugmakers NewLink Genetics ($NLNK) and Sarepta Therapeutics ($SRPT) have stepped up with early-stage therapies they believe could help fight the virus.
- read the statement