Chimerix Stumbles Over Late Stage Results

Health and Healthcare

Published: February 22, 2016 9:45 am

Last Updated: January 13, 2020 12:54 pm

Chimerix Inc. (NASDAQ: CMRX) had a bad start to the week as it tumbled in early trading on Monday, following some late stage clinical trial results. The company announced detailed results from its Phase 3 Suppress trial of brincidofovir for the prevention of cytomegalovirus (CMV) in patients undergoing hematopoietic cell transplantation (HCT). Ultimately, its Suppress trial did not meet the primary endpoint of prevention of clinically significant CMV infection at Week 24 following HCT.

Despite the results showing that brincidofovir had a clear antiviral effect, preventing CMV reactivation particularly in patients at higher risk for CMV infection, there was not enough traction behind the results to meet the primary endpoint.

However, the failure to meet the primary endpoint was more associated with CMV events in the post-treatment period among subjects on the brincidofovir arm, driven by higher use of corticosteroids and other immune suppressing therapies for the treatment of presumptive graft versus host disease.

Chimerix Chief Medical Officer W. Garrett Nichols, M.D., M.S., commented on the study:

We are disappointed that the SUPPRESS trial did not confirm the benefits of brincidofovir in preventing CMV in these high-risk HCT recipients, but we are encouraged by the clear antiviral effects of brincidofovir during the on-treatment period, and in key subgroups of higher-risk patients in this study. We also saw more favorable results when the SMMP was appropriately implemented. With the promising data to date for brincidofovir in adenovirus and smallpox, we continue to believe in the near-term potential of brincidofovir to address DNA viral infections in HCT recipients and in other at-risk populations,” “We would like to thank the patients and investigators for their participation in SUPPRESS, and their important contribution to furthering our understanding of CMV management in the HCT setting.

Shares of Chimerix fell more than 35% to a new 52-week low of $4.91 Monday morning, compared with a 52-week high all the way up at $58.04. For now, the consensus analyst price target is $16.64.

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