Chimerix Provides Update on Research and Development Progress
Highlights Advancement of Second Clinical Candidate, CMX16669, for CMV and BK Virus
DURHAM, N.C., Oct. 16, 2014 (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 the company’s R&D programs, including the addition of a potential new product candidate, CMX16669, to its development pipeline.
R&D Update Meeting Overview
• Candidate Selection of CMX16669
The company has discovered, developed and selected a novel clinical candidate, CMX16669, for BK virus and cytomegalovirus (CMV). This new product candidate has demonstrated potent in vitro activity against CMV and BK virus, with a promising safety profile in vitro and in pilot toxicity studies in animals. The modified lipid tail may enable very low oral doses, based on initial animal studies. Chimerix plans to initiate clinical trials in 2015.
Michael Rogers, PhD, Chief Development Officer, said, “Our team of virologists and chemists with extensive expertise in antiviral research has delivered a unique clinical candidate. Our discovery program is focused on leveraging our library of novel structures designed to hit antiviral targets, while harnessing our complementary drug delivery lipid technology which has a wide range of potential applications.”
• Brincidofovir for Ebola Virus Disease
The company announced that it has worked closely with the FDA to develop a Phase 2 clinical trial protocol to assess the safety, tolerability, and efficacy of brincidofovir in patients who are confirmed to have Ebola Virus Disease. An investigational new drug (IND) application for brincidofovir (BCV) for Ebola Virus Disease (EVD) has been authorized by the FDA. The FDA has authorized a Phase 2 protocol for BCV for EVD to begin immediately. Brincidofovir tablets are available for immediate use in clinical trials.
• AdVise, SUPPRESS and Smallpox Clinical Trials
The company also reviewed positive brincidofovir data from the open-label pilot portion of AdVise, showing a potential survival benefit for patients with adenovirus infection. This was presented by Dr. Michael Grimley, Associate Professor, Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children’s Hospital. Additionally, the company reviewed its Phase 3 SUPPRESS trial for the prevention of cytomegalovirus (CMV) in hematopoietic cell transplant (bone marrow transplant), as well as the brincidofovir development program for the treatment of smallpox as a medical countermeasure due to a bioterror attack or accidental release.
About Brincidofovir (BCV, 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 viruses in the herpes virus family and adenoviruses. Brincidofovir has not been associated with kidney or bone marrow toxicity in over 1,000 patients treated to date, side effects that can be treatment limiting with currently available antivirals. Building on the positive Phase 2 results in cytomegalovirus (CMV) prevention, Chimerix initiated the Phase 3 SUPPRESS trial in 2013. 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 recently initiated AdVise, a Phase 3 trial in adenovirus, which is an often-fatal viral infection with no approved treatment; enrollment is ongoing for the pilot portion of the trial. Chimerix is also 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.
Chimerix is a biopharmaceutical company dedicated to discovering, developing and commercializing novel, oral antivirals in areas of high unmet medical need. Chimerix’s proprietary technology has given rise to brincidofovir (CMX001), a clinical-stage nucleotide analog lipid-conjugate, which has demonstrated potent antiviral activity and safety in convenient, orally administered dosing regimens. 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 pilot portion of the Phase 3 AdVise trial of brincidofovir for treatment of adenovirus (AdV) infection. Chimerix is also working with BARDA to develop brincidofovir as a medical countermeasure against smallpox. For further information, please visit Chimerix’s website, www.chimerix.com.
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.
Joseph T. Schepers
Investor Relations and Corporate Communications