Press Release

Data supports further clinical evaluation of brincidofovir for the treatment and prevention of BK virus

DURHAM, N.C., Oct. 27, 2018 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX) today announced data from two preclinical studies which assessed the in vivo antiviral activity of brincidofovir (BCV) against polyomavirus. These studies are part of the company’s ongoing effort to develop antivirals in high unmet medical need areas, including hematopoietic cell transplant (HCT) and solid organ transplant patient populations. These data will be presented at the American Society of Nephrology’s Kidney Week 2018, held October 23-28 in San Diego, CA.

Polyomaviruses are a family of small DNA viruses that persistently infect their hosts for life. BK virus (BKV) is a human polyomavirus that presents a significant risk to those who are immunocompromised and immunosuppressed. Approximately 15 percent of kidney transplant recipients develop BKV in the first year following transplant, and infection can lead to kidney damage and organ loss. Current treatment for BKV is a reduction of immunosuppression, which can result in organ rejection.

“Almost 6,000 kidney transplant recipients in the United States and Europe develop BK infection annually and are at risk of losing their new kidney. The prevention and treatment of BK virus represents a significant unmet need,” said Garrett Nichols, MD, MS, Chief Medical Officer of Chimerix. “These preclinical studies of brincidofovir provide further evidence of its antiviral activity against polyomavirus.”

These two studies evaluated BCV’s effect against MuPyV, a mouse polyomavirus closely related to the human BK virus. In these studies, mice with MuPyV were treated with BCV either 24 hours after being infected or prophylactically for a full week prior to infection. Data from the two studies show that BCV demonstrated significant antiviral activity against MuPyV and showed no safety signals across BCV doses administered. In mice treated after infection with MuPyV, BCV delivered via intraperitoneal injection once daily, twice weekly or once weekly reduced kidney viral loads by 100-fold relative to those that received placebo, while administration prophylactically showed that BCV 20 mg/kg or higher decreased viral load in the kidney by approximately 10-fold.

“These animal mouse studies build on our growing understanding of brincidofovir’s potential to prevent or treat BK virus infection in recipients of kidney transplants or after a stem cell transplant,” said Dr. Nichols. “A previous Phase 2 study in stem cell transplant recipients showed improved kidney function and reduced renal impairment in brincidofovir-treated patients, suggesting its potential activity against BK virus; the new in vivo data confirm what was seen in past in vitro studies, showing that brincidofovir is active against polyomaviruses. With results from these studies in hand, we look forward to progressing a clinical study of brincidofovir against BK virus.”

Chimerix presentations during the Pharmacology Poster Session on October 27, 2018 at 10:00 a.m. PDT (1:00 p.m. EDT):

• Activity of Brincidofovir (BCV) against Murine Polyoma Virus (MuPyV) in a mouse infection model [SA-PO641]
• Brincidofovir (BCV) Demonstrates Antiviral Activity against Murine Polyoma Virus (MuPyV) in a mouse model of acute infection [SA-PO642]

About 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 adenoviruses and variola virus, the virus that causes smallpox. Brincidofovir has a high barrier to resistance, no myelosuppression and a low risk of nephrotoxicity. Brincidofovir tablets, oral suspension and intravenous formulations are in development. Brincidofovir has received Fast Track designation from the FDA for cytomegalovirus (CMV) and smallpox. Brincidofovir has also received Orphan Medicinal Product Designation from the European Commission for the treatment of adenovirus, for the prevention of CMV disease, and for the treatment of smallpox, and Orphan Drug Designation from the FDA for the treatment of smallpox. 

About Chimerix

Chimerix is a biopharmaceutical company dedicated to discovering, developing and commercializing medicines that improve outcomes for immunocompromised patients. Chimerix's proprietary lipid conjugate technology and compound library have produced brincidofovir (BCV, CMX001); CMX157, which was licensed to ContraVir Pharmaceuticals; and CMX521, the first clinical-stage direct-acting antiviral for the treatment and prevention of norovirus. 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 our current or future clinical trials of brincidofovir may not be successful, that FDA and other regulatory authorities may not approve brincidofovir or brincidofovir-based regimens, and that 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. Similar risks and uncertainties apply to the Company’s development of CMX521. These risks, uncertainties and other factors could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in the Company's filings with the Securities and Exchange Commission, including without limitation the Company's most recent Quarterly Report on Form 10-Q 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. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

CONTACT:
Investor Relations:
Michelle LaSpaluto
(919) 972-7115
ir@chimerix.com
or
Will O’Connor
Stern Investor Relations
Will@sternir.com
(212) 362-1200

Media:
Laurie Masonson
W2O Group
lmasonson@w2group.com
(917) 459-6164

Source: Chimerix, Inc.