×

Chimerix Completes Targeted Enrollment for Brincidofovir Phase 3 AdVise Trial for Adenovirus Infection

DURHAM, N.C., Aug. 3, 2015 (GLOBE NEWSWIRE) -- Chimerix, Inc. (NASDAQ:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced completion of enrollment of the targeted 200 patients in the Phase 3 AdVise trial evaluating brincidofovir for the treatment of adenovirus infection in immunocompromised patients.

Adenovirus is a common virus that leads to upper respiratory or gastrointestinal infections in individuals with a healthy immune system, but it can be rapidly fatal in individuals with a weakened immune system, particularly those who have recently undergone a hematopoietic cell transplant (HCT), or bone marrow transplant. There is no approved antiviral treatment for adenovirus infection.

"Disseminated adenovirus infection in HCT recipients has a very high mortality rate and we do not have an adequate treatment that is sufficiently effective and tolerated. Through this trial, we are finding that adenovirus infection may be more frequent than previously thought, particularly in pediatric patients, and screening may play a vital role in improving outcomes," said Michael S. Grimley, MD, Associate Professor of Clinical Pediatrics, Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, and lead investigator for AdVise. "Brincidofovir has the potential to significantly change our approach to treating this life-threatening infection, and I'm hopeful that the results of this study will provide the data we've been anticipating."

The Phase 3 AdVise trial began enrolling in March 2014. Patients with confirmed adenovirus infection receive brincidofovir orally twice-weekly for 12 weeks, and are followed for a minimum of 12 weeks after treatment. The trial is made up of three cohorts: Cohort A comprised of allogeneic bone marrow transplant recipients with asymptomatic or localized adenovirus; Cohort B comprised of allogeneic bone marrow transplant recipients with disseminated adenovirus disease; and Cohort C comprised of other immunocompromised patients, including autologous bone marrow transplant recipients, solid organ transplant recipients, and other patients with serious adenovirus infections. Over 100 patients were enrolled in Cohort B with disseminated adenovirus infection, as planned.

"The rapid enrollment of this pivotal trial underscores the significant need for an antiviral that can be used to treat these vulnerable patients with adenovirus infection. We are grateful to all of the patients and physicians who participated in this study, as we move closer toward the potential for the first approved treatment for this life-threatening infection," said W. Garrett Nichols, MD, MS, Chief Medical Officer of Chimerix.

The primary endpoint of this pivotal study is overall survival, with a comparison of outcomes between patients who received open-label brincidofovir to outcomes in historical matched controls from the same clinical sites. With no approved treatment for adenovirus, short-term mortality rates have been reported as high as 80 percent in patients with disseminated disease. Earlier this year, preliminary results from the initial 85 patients enrolled in AdVise and treated with brincidofovir showed a mortality rate of less than 40 percent for bone marrow transplant recipients with disseminated adenovirus disease and for the patient population overall. Preliminary results also showed that many of these patients had more than one active DNA viral infection at the time of enrollment.

The company plans to formally review with the U.S. Food and Drug Administration (FDA) a strategy of submitting a new drug application (NDA) for brincidofovir with efficacy and safety data from both the pivotal AdVise and SUPPRESS trials. The Phase 3 SUPPRESS trial for the prevention of CMV infection in bone marrow transplant recipients completed enrollment in June 2015.

About Hematopoietic Cell Transplantation

More than 70,000 hematopoietic cell transplants (HCT, or bone marrow transplants) are performed each year worldwide, most frequently to treat patients with certain cancers of the blood and bone marrow, or to address genetic diseases. Due to chemotherapy and the immune suppression associated with HCT, patients are highly susceptible to viral, bacterial and fungal infections. These complications are a significant cause of morbidity and mortality in the months following the transplant, and too often the high risk of infection in the first year after transplant results in patients and their families deciding not to undergo a potentially curative transplant.

About Adenovirus

Adenovirus causes upper respiratory infections, including the common cold, in individuals with a functional immune system. However, in people with a weakened immune system, such as patients who have undergone a transplant, adenovirus can lead to life-threatening infections, including pneumonia and hepatitis. Disseminated adenovirus disease can be associated with a mortality rate of up to 80 percent in patients who are undergoing hematopoietic cell transplant (HCT), or bone marrow transplant. No therapies are approved for the treatment of adenovirus.

About Brincidofovir (CMX001)

Chimerix's lead product candidate, brincidofovir, is an oral nucleotide analog that has shown in vitro antiviral activity against all five families of DNA viruses that affect humans, including the herpesviruses and adenovirus. Brincidofovir has not been associated with kidney or bone marrow toxicity in over 1,000 patients treated to date. Based on the clinically and statistically significant Phase 2 results in cytomegalovirus (CMV) prevention, Chimerix initiated the 450 patient Phase 3 SUPPRESS trial, which completed enrollment in June 2015. If positive, data from SUPPRESS will support Chimerix's initial regulatory submission for brincidofovir for the prevention of CMV infection in adult hematopoietic cell transplant (HCT) recipients. Chimerix has also completed enrollment in AdVise, a Phase 3 trial in patients with adenovirus infection, an often-fatal viral infection with no approved treatment. AdVise completed enrollment in August 2015. Chimerix is working with the Biomedical Advanced Research and Development Authority (BARDA) to develop brincidofovir as a medical countermeasure against smallpox. Brincidofovir has received Fast Track designation from the FDA for CMV, adenovirus, and smallpox.

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, CMX157 which was licensed to ContraVir Pharmaceuticals in 2014, and early clinical candidates including CMX669. For further information, please visit Chimerix's website, www.chimerix.com.

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 March 31, 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.

For further information, please visit Chimerix's website, www.chimerix.com

CONTACT: Joseph T. Schepers Executive Director, Investor Relations and Corporate Communications ir@chimerix.com 919-287-4125Source:Chimerix, Inc.