- Full Enrollment of Pivotal SUPPRESS Trial Anticipated in Summer 2015 -
- AdVise Enrollment Now Over 100 Patients -
DURHAM, N.C., Feb. 26, 2015 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today provided an update on its ongoing Phase 3 SUPPRESS trial.
The SUPPRESS trial is evaluating brincidofovir for the prevention of clinically significant cytomegalovirus (CMV) infection in hematopoietic cell transplant (HCT) recipients. Over 80 percent of the planned 450 subjects have now been enrolled. The last patient is expected to be enrolled in the summer of 2015 with data anticipated in early 2016. The company had previously anticipated full enrollment of the SUPPRESS trial in early 2015.
In addition to the primary endpoint of prevention of CMV infection, SUPPRESS includes a significant number of secondary endpoints to investigate brincidofovir's potential benefits in the setting of HCT. These important secondary endpoints include rates of infections caused by other dsDNA viruses, rates of bacterial and fungal infections that can be associated with CMV reactivation and known side-effects of currently available therapies, hospitalizations, mortality, and assessments of healthcare utilization. Brincidofovir, if approved, will be the first compound indicated for the prevention of CMV infection in HCT recipients, with the potential to show benefits in other infections that negatively impact high-risk HCT recipients. The company believes that the antiviral activity of brincidofovir in preventing and treating multiple dsDNA viruses will be clinically important; more than half of the patients who have enrolled in Chimerix's AdVise trial for the treatment of adenovirus were fighting two or more viral infections.
"We continue to progress our clinical development program for brincidofovir, with the top priority of completing enrollment for SUPPRESS," Dr. M. Michelle Berrey, President and CEO of Chimerix, said. "While we had targeted early 2015 for finalizing enrollment, we believe that obtaining the clinical data from our secondary endpoints is critical for demonstrating the potential clinical and healthcare utilization benefits of brincidofovir, particularly as this agent has a long patent life into 2034."
The company's second pivotal trial, AdVise, is evaluating brincidofovir for the treatment of adenovirus infections in immunocompromised patients and has now enrolled over 100 subjects in the United States and Canada. The company expects to expand its study of brincidofovir for adenovirus infection into Europe and Australia following interest from clinicians in these regions. Later in 2015, the company will formally review with the U.S. Food and Drug Administration (FDA) a strategy of new drug application (NDA) submission for brincidofovir that will include efficacy and safety data from both the AdVise and SUPPRESS trials.
About Chimerix
Chimerix is a biopharmaceutical company dedicated to discovering, developing and commercializing novel, oral antivirals in areas of high unmet medical need. Chimerix's proprietary lipid conjugate technology has produced brincidofovir (CMX001), a clinical-stage nucleotide analog lipid conjugate, which has potent in vitro antiviral activity and a favorable safety profile in clinical studies conducted to date. Chimerix is currently enrolling SUPPRESS, a Phase 3 study of brincidofovir for the prevention of cytomegalovirus (CMV) in adult hematopoietic cell transplant (HCT) recipients. In addition, Chimerix is enrolling the Phase 3 AdVise trial of brincidofovir for treatment of adenovirus (AdV) infection. Chimerix is working with BARDA to develop brincidofovir as a potential medical countermeasure against smallpox. For further information, please visit Chimerix's website, www.chimerix.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Chimerix's filings with the Securities and Exchange Commission, including without limitation its most recent Quarterly Report on Form 10-Q, its most recently filed Current Reports on Form 8-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Chimerix undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.