Chimerix Announces Fourth Quarter and Full Year 2018 Financial Results
- Reports Positive Preliminary Top-line Data from Second Rabbitpox Study -
- Type C Meeting Requested with FDA - Regarding Virologic Endpoint -
- Conference Call at 8:30 a.m. ET Today -
DURHAM, N.C., March 5, 2019 -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company developing novel antivirals to address unmet medical needs, today reported financial results and provided a corporate update for the fourth quarter and full-year ended December 31, 2018.
“During 2018 and in recent weeks, we made important strides towards advancing our antiviral pipeline across a number of important infectious disease indications. In particular, we were very pleased with the preliminary data from our rabbitpox study, which showed statistically significant survival benefit in brincidofovir (BCV) treated rabbits,” said Garrett Nichols, M.D., M.S., Chief Medical Officer of Chimerix.
“In addition, we continue to advance brincidofovir for the treatment of adenovirus (AdV) in our AdAPT study, with the goal of completing this trial as quickly as possible given the high mortality associated with this disease. We have, however, faced delays in enrollment of the trial, and will provide an update on projected enrollment completion in mid-2019. We have also submitted a request for a Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss adenoviral burden, the primary endpoint for AdAPT, as a potential surrogate marker for mortality,” concluded Dr. Nichols.
BCV for Smallpox
Today, Chimerix reports preliminary top-line results from the in-life portion of our second rabbitpox efficacy study conducted under the FDA Animal Efficacy Rule.
The study was designed to determine the effect of administering BCV to animals at certain times (3, 4, 5 or 6 days) after infection with the rabbitpox virus. Based on these preliminary findings, the study met its primary endpoint. The top-line survival results are as follows:
BCV treatment 3 days post-infection
BCV treatment 4 days post-infection
BCV treatment 5 days post-infection
BCV treatment 6 days post-infection
No treatment (placebo)
P-value vs. Placebo
Data from this study are consistent with those reported from the Company’s first pivotal rabbitpox study, conducted in 2015.
The following information was filed by Chimerix Inc (CMRX) on Tuesday, March 5, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.