Chimerix (NASDAQ: CMRX) reported Q1 EPS of ($0.57), $0.09 better than the analyst estimate of ($0.66). Revenue for the quarter came in at $1.2 million versus the consensus estimate of $2.79 million.

Today, Chimerix provided topline results from an interim analysis of week 24 data from AdVise which shows a strong antiviral effect which was correlated with overall survival. The company is working closely with medical advisors to plan a prospective, comparative trial in patients with serious adenovirus (AdV) infection.

In August 2015, the Company completed enrollment of the AdVise trial of brincidofovir (BCV) as a treatment for serious AdV infection. Pediatric and adult patients who have undergone allogeneic hematopoietic cell transplants (HCT) are at especially high risk for serious or fatal AdV infections due to profound immunodeficiency. Mortality rates of 50 to 80 percent have been reported in the literature for disseminated AdV disease. Rates of AdV infection with virus detected in the blood or other body fluids are higher in pediatric transplant recipients than in adults, and have resulted in many medical centers instituting screening protocols to detect AdV infection before the virus causes serious disease. There is currently no approved therapy for AdV infection, and although progression to disseminated disease in pediatric HCT recipients occurs in a small proportion of patients with AdV viremia, mortality rates for pediatric patients with confirmed AdV disease is greater than 50 percent in the first three months after diagnosis.

Pediatric and adult patients who were enrolled in the AdVise study were placed into Cohort A, B, or C based on their underlying immunodeficiency and extent of AdV disease:

• Cohort A - allogeneic HCT recipients with asymptomatic or limited AdV infection
• Cohort B - allogeneic HCT recipients with disseminated AdV disease
• Cohort C - autologous HCT recipients, solid organ transplant recipients, and other immunocompromised patients

All subjects enrolled in the AdVise trial received 12 weeks of open-label oral brincidofovir, and are followed for 24 weeks after completing treatment. Final data will include follow-up through week 36 (24 weeks after the last dose of BCV), and will be available in the second half of 2016.

Top-line results from the AdVise trial at week 24 include the following:

• BCV rapidly reduced AdV levels in the blood (viral load to a level below the limit of detection) in a majority of these highly immunocompromised patients, even in patients who had previously received cidofovir. Rapid reductions in AdV viral load were correlated with improved survival at day 90 and at week 24 following diagnosis in pediatric patients.
• Two-thirds of the subjects in AdVise Cohort B (disseminated AdV disease) were pediatric allogeneic HCT recipients. Pediatric subjects had a 32 percent all-cause mortality at day 90, and 42 percent all-cause mortality at week 24. There was a smaller group of adult allogeneic HCT recipients in Cohort B, and AdV diagnoses occurred in patients with less evidence of immune reconstitution (lower lymphocyte count) than in pediatric patients. In adults, all-cause mortality at day 90 was 57 percent and at week 24 was 71 percent.
• Importantly, treatment discontinuations due to gastrointestinal (GI) adverse effects were low (8 percent), particularly in pediatric subjects (4 percent). Treatment discontinuations due to graft-versus-host-disease (GVHD) were low in both pediatric and adult patients (3 percent each). The overall safety profile of brincidofovir was consistent with prior trials, including no apparent drug-related nephrotoxicity or myelosuppression.
• Despite a rigorous attempt to collect historic controls from the same medical centers as patients from AdVise, the baseline risk factors for the control patients as assessed by medical reviewers did not reflect the high-risk patients enrolled in AdVise and thus did not provide a valid comparison for outcomes. Controls were selected based upon age, transplant type, and presence or absence of disseminated AdV infection. However, other unmatched characteristics known to confer an increased risk of AdV-related mortality, such as confirmed end-organ AdV disease, low lymphocyte count, and GVHD, were less frequent in the matched controls. A meaningful difference in overall survival between AdVise and the historic controls was thus not observed.
• In the absence of a valid comparator cohort for the open-label data from AdVise, the company is planning a prospective, comparative trial of brincidofovir in AdV that will allow stratification of patients based on risk factors for outcomes. The Company plans to meet with the U.S. Food and Drug Administration (FDA) in the coming months to review data from the interim analyses of AdVise and to discuss the regulatory pathway for brincidofovir in AdV, including the design of a potential comparative trial. A similar review is also planned with European regulators.
• Brincidofovir for the treatment of AdV continues to be available through the expanded access Study CMX001-351 (NCT 02596997) and through an Emergency IND or foreign equivalent, with approximately 100 patients treated to-date in 2016.

W. Garrett Nichols, MD, MS, Chimerix’s Chief Medical Officer said, “The recently completed AdVise trial is the largest clinical study ever conducted in serious adenovirus infections. The risk factors and predictors of improved survival in pediatric and adult patients with adenovirus disease identified from the prior studies of brincidofovir in adenovirus infection, and now further informed by data from AdVise, will guide the design of a comparative trial of brincidofovir as a potential treatment for adenovirus infection.”

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