Chimerix Initiates Phase 3 SUSTAIN and SURPASS Trials of Brincidofovir for Prevention of Cytomegalovirus Disease in Kidney Transplant Recipients
"SUSTAIN and SURPASS address the need for new CMV prevention therapies in the kidney transplant population," said
SUSTAIN is designed to demonstrate the safety and efficacy of brincidofovir for the prevention of CMV disease in kidney transplant recipients at high risk of CMV disease. It is a blinded, non-inferiority study of brincidofovir versus valganciclovir in kidney transplant recipients who have not been previously infected with CMV (CMV seronegative recipient, or "R-") and who have no immunity to CMV. These CMV seronegative patients who receive a kidney from a CMV seropositive (D+) donor are at high risk of CMV infection and disease. The primary endpoint of the study is CMV disease, with secondary endpoints related to renal function at one year, a measurement closely correlated with long-term kidney graft survival. The trial is expected to enroll approximately 750 patients with 1:1 randomization to brincidofovir or valganciclovir for 200 days following the transplant.
SUSTAIN is an important study as it will determine the safety and efficacy of brincidofovir in the population at highest risk of CMV disease (R-/D+) but which makes up less than 20 percent of patients who are receiving a kidney transplant. A majority of kidney transplant recipients in the US and
SURPASS is a blinded, non-inferiority study of brincidofovir versus valganciclovir in kidney transplant recipients who are CMV seropositive (R+). The primary endpoint is CMV disease, with secondary endpoints related to renal function at six months, a measurement closely correlated with long-term kidney graft survival. The trial is expected to enroll approximately 520 patients with 1:1 randomization to brincidofovir or valganciclovir for 100 days following the transplant. The same dose of brincidofovir that was studied in the SUPPRESS trial in HCT recipients, 100 mg twice-weekly, will be studied in both the SUSTAIN and SURPASS trials.
In addition,
Cytomegalovirus Infection in Kidney Transplant Recipients
Cytomegalovirus (CMV) is a member of the herpesvirus family and is a significant cause of decreased renal function in kidney transplant patients. While graft survival has improved with advances in immunosuppressive medicines, ten-year graft survival rates are still below 50 percent. Together, SUSTAIN and SURPASS provide an opportunity to demonstrate the ability of brincidofovir to prevent CMV disease compared with the current standard-of-care, valganciclovir. In addition, these trials will evaluate the impact of brincidofovir on kidney function at 6 and 12 months following transplant. In the Phase 2 study of brincidofovir in HCT recipients, a statistically significant improvement in kidney function was seen in patients who received brincidofovir compared with those who received placebo.
About Brincidofovir (CMX001)
About
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility that the FDA and other regulatory authorities may not approve brincidofovir or brincidofovir-based regimens in the currently anticipated timelines or at all, and marketing approvals, if granted, may have significant limitations on their use. As a result, brincidofovir may never be successfully commercialized. In addition, Chimerix may be unable to file for regulatory approval for brincidofovir with other regulatory authorities in the currently anticipated timelines. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Chimerix's Quarterly Report on Form 10-Q for the quarter ended June 30, 2015, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Chimerix, and Chimerix assumes no obligation to update any such forward-looking statements.
CONTACT:Source:Joseph T. Schepers Executive Director, Investor Relations and Corporate Communications ir@chimerix.com 919-287-4125
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