Chimerix Reports Encouraging Results From CMX001 Phase 2 Adenovirus Trial

(RTTNews) - Chimerix, Inc. (CMRX), a biopharmaceutical company, announced top line data from the exploratory Phase 2 study of CMX001 as preemptive therapy for adenovirus or AdV infection, the first interventional trial in AdV infection. In this trial in allogeneic hematopoietic cell transplant or HCT recipients, the 100 mg dose given twice weekly showed decreased levels of AdV viremia and demonstrated a potential benefit in reducing both progression to AdV disease and all-cause mortality, compared to subjects who received placebo or CMX001 given once weekly. Planned intent-to-treat analyses as well as exploratory analyses in specific patient groups were consistent in trends favoring the CMX001 BIW regimen over placebo, though statistical significance was not established in this exploratory trial.

In addition, Chimerix announced the acceptance of the proof-of-concept data as an oral late-breaker presentation at the upcoming 53rd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy or ICAAC meeting being held in Denver, CO on September 10-13, 2013.

Chimerix's blinded, placebo-controlled proof-of-concept trial, Study 202, evaluated the use of CMX001 at an earlier stage of AdV infection, when patients had detectable viremia but before the appearance of symptoms of disease. Chimerix plans to review the Study 202 data with the U.S. Food and Drug Administration in the fourth quarter of 2013, in the context of a Pediatric Plan for CMX001.

Further, the company looks forward to initiating the Phase 3 SUPPRESS trial later this quarter.

In a separate press release, Chimerix reported a wider net loss of $12.5 million, or $0.91 per share, for the 2013 second quarter, versus a $4.3 million, or $3.44 per share loss, a year before.

Revenues for the three-month period fell to $808,000, from $6.2 million for the same period in 2012, mainly based on the completion of the base segment of Chimerix's contract with BARDA in the second quarter of 2013.