Chimerix provided an update on multiple clinical development programs including oral brincidofovir (BCV), intravenous (IV) BCV, and CMX521. Initiation of AdAPT Study of Oral Brincidofovir in Adenovirus: The Company reports the initiation of the AdAPT Study (Adenovirus after Allogeneic Pediatric Transplantation). This study is targeting enrollment of 141 pediatric allogeneic hematopoietic stem cell transplant (HCT) recipients with confirmed adenovirus (AdV) infection; patients will be randomized 2:1 to receive short-course oral BCV or local standard-of-care (SOC) treatment at approximately 30 sites in Europe and the United States. The primary endpoint of the study is a comparison of the average adenovirus viral burden (as measured by AdV DNA levels in blood) over 16 weeks in subjects treated with short-course oral BCV versus those who receive local SOC. The study is 90% powered to show the superiority of reduced adenoviral burden in brincidofovir-treated patients compared to SOC. The study will also evaluate the correlation of AdV burden (and its clearance) with clinical outcomes including survival. Enrollment is estimated to complete in 2019. IV Brincidofovir Progresses to Phase 2 Studies: The Company announced the successful completion of the multiple ascending dose (MAD) study of IV BCV in healthy subjects. This study evaluated the safety, tolerability and pharmacokinetics of IV BCV 10 mg given twice weekly and IV BCV 20 mg given once weekly in healthy subjects for two to four weeks. IV BCV was well-tolerated at all dose levels, with no dose-limiting clinical adverse events. Importantly, there was no diarrhea reported for IV BCV 10 mg dosed twice weekly, a dose that provides drug levels equivalent to oral BCV 100 mg which demonstrated antiviral activity in previous late-stage clinical studies. Proposals for studies of IV BCV in virally-infected patients have progressed to regulatory review in Europe and are expected to provide data in the second half of 2018. Preparation Underway for European Regulatory Submission for Smallpox: In late November, the Company received advice from the European Medicines Agency (EMA) on the development plan for smallpox, in which the submission of a marketing application with data from completed studies, including the large rabbitpox efficacy study, VIR-041, was discussed. This rabbitpox study, as previously reported, demonstrated 100% survival in animals with confirmed viral infection treated with BCV, a clinically and statistically significant improvement compared with <50% survival in animals that received placebo. This study in combination with supportive mousepox study data was considered sufficient for review by EMA. The Company is in the process of preparing for a marketing application submission to EMA in early 2019. Chimerix intends to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), contingent upon the results of animal efficacy studies to be conducted in 2018. CMX521 for Norovirus: Chimerix announces the initiation of its first-time-in-human study of CMX521, a nucleoside analog identified from the Chimerix Chemical Library, as a potential treatment and/or prevention for norovirus. The Phase 1 study will evaluate the pharmacokinetics, safety and tolerability of CMX521 in up to 50 adult subjects. The study also includes the collection of gut biopsy specimens, which will allow determination of active drug concentrations in the target gut tissue. Study results are expected in mid-2018. Brincidofovir: Chimerix's lead product candidate, brincidofovir, is a nucleotide analog that has antiviral activity against all five families of DNA viruses that affect humans, including the herpesviruses and adenoviruses. Brincidofovir has a high barrier to resistance, no myelosuppression and a low risk of nephrotoxicity. Brincidofovir has received Fast Track designation from the FDA for adenovirus, cytomegalovirus (CMV) and smallpox. Brincidofovir has also received Orphan Medicinal Product Designation from the European Commission for adenovirus, CMV, and smallpox.