Chimerix Inc. (NASDAQ: CMRX) absolutely led the bears in Monday’s trading session on less-than-favorable results from a late-stage trial. The company announced that its Phase 3 Suppress trial of brincidofovir in patients undergoing hematopoietic cell transplantation (HCT) did not achieve its primary endpoint for the prevention of clinically significant cytomegalovirus (CMV) infection through week 24 after transplant.
According to this study, during the on-treatment period through week 14 after HCT, fewer patients in the brincidofovir arm had a CMV infection, consistent with the positive antiviral effect of the compound seen in the Phase 2 study. But this was not the end of the story, during the 10 weeks off treatment from week 14 to week 24, there was an increase in CMV infections in the brincidofovir arm compared to the control arm.
There was also a non-statistically significant increase in mortality in the brincidofovir arm compared to the control arm.
The company was clearly disappointed in its top-line results from Suppress, but it “remains committed to better understanding the full data set as we consider potential paths forward for brincidofovir.” Currently Chimerix is taking an optimistic point of view, considering its strong cash position, leadership team and brincidofovir patent exclusivity through 2034.
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W. Garrett Nichols, M.D., Chimerix’s chief medical officer, commented on the results:
The population of allogeneic stem cell transplant recipients is heterogeneous and complex; we will be evaluating the sub-groups of patients within Suppress, such as T-cell depleted transplant recipients who have a lower risk of GVHD, to better understand these results and inform our next steps. We are reaching out to investigators and other experts to help us assess the complete data set to understand what may have caused the results of the SUPPRESS trial to differ substantially from those seen in the Phase 2 study. Additionally, we are in communication with the U.S. Food and Drug Administration and other regulatory bodies, and will share any updates on the brincidofovir clinical program when we can. With data currently in hand, we believe that brincidofovir may ultimately demonstrate a positive risk-benefit profile for the treatment of adenovirus and smallpox, as well as use in other populations in need of a novel compound for DNA viral infections.
Over the course of 2015, the stock has underperformed the market. In fact, compared to Thursday’s closing price, the stock is down nearly 12% year to date, and this is not even considering the carnage from Monday’s session.
Shares of Chimerix were last seen trading down about 80% at $7.30, with a consensus analyst price target of $61.27 and a 52-week trading range of $7.21 to $58.04.
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