|Ebolavirus under an electron microscope--Courtesy of CDC|
Chimerix has outlined plans for a small Phase II study of its powerful antiviral brincidofovir as a counterpunch to Ebola.
In recent weeks the biotech ($CMRX) has added details on its study design listed on clinicaltrials.gov. The trial calls for 50 patients aged 2 months to 75 years old who test positive for the lethal Ebola virus. While the online site notes that no recruiting is being done yet, Chimerix lists a company contact for the study along with plans to start off Ebola patients with a 200-mg dose of brincidofovir (CMX001), to be followed up with four 100-mg doses over the next two weeks. The study is slated to wrap up a little more than a year from now.
Back at the beginning of this month Chimerix garnered headlines around the world when the antiviral was used in a failed attempt to save a newly diagnosed--and very sick--patient in Dallas. Another case involved freelance journalist Ashoka Mukpo, who did recover. More compassionate use requests were expected, and Chimerix CEO Michelle Berrey immediately returned to the FDA to see if they could rush out a design for a formal study that could be added to their development plans for the program.
|Chimerix CEO Michelle Berrey|
About two weeks ago Chimerix noted that the FDA had provided a green light for the Phase II, but the company declined to disclose the specifics. And a company spokesperson did not immediately respond to a query from FierceBiotech on Tuesday.
Chimerix has been in this position before. In the spring it hustled together a pilot program for adenovirus infections after the biotech had rejected a compassionate use request from a desperately ill child. That case quickly swelled into an online tempest as social media outlets hosted furious reactions from the public--a response that was only quelled once the child was treated in the pilot program. Now Chimerix is using a similar strategy for Ebola, looking to start a program that will enlist infected hospital workers in the U.S. and Europe, as Berrey recently explained to FierceBiotech.
Brincidofovir is a lipid-conjugated version of cidofovir--one of Gilead's IV antivirals--that's specifically designed to amp up the antiviral impact with a pill while sparing kidneys from a toxic threat. Its ability to get into cells more effectively than cidofovir has vastly improved its punch against all 5 DNA viral infections but has also raised questions about whether it could prove a threat to all rapidly growing cells, including cells in the bone marrow.
- here's the study outline on clinicaltrials.gov
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