PRNewswire - December 17, 2001

"There is a real need for new safe and potent treatment options for hepatitis B patients. We are very impressed with the antiviral potency and safety exhibited by LdT in this study," said Ching-Lung Lai, M.D., Professor of Medicine at the University of Hong Kong and principal investigator on the study. "The marked suppression of serum viral levels after four weeks of LdT treatment compares very favorably with other approved and investigational hepatitis B therapies. We are pleased to be participating in studies of longer duration to measure the full potential of this exciting new drug."

Study Description

The randomized phase I/II study is designed to evaluate safety and short-term antiviral activity of LdT in adults with chronic hepatitis B, and to assess optimal dosing levels of LdT for future large-scale clinical trials. Novirio has conducted the study in conjunction with clinical researchers at the University of Hong Kong and the National University Hospital in Singapore under a United States FDA Investigational New Drug (IND) application. Over the twenty-eight day treatment period an aggregate of 30 adults with chronic hepatitis B infection were given LdT tablets once daily at assigned doses, followed by three months of continued monitoring. One additional patient on each dose arm received placebo. Treatment responses were measured as reductions in detectable HBV DNA in serum during four weeks of treatment.

Study Results

For patients receiving daily LdT doses of 100 mg or more, the study results indicate greater than 1000-fold reductions in serum virus load. Patients taking 400 mg per day exhibited average reductions in serum viral load of 3.63 log10 (about 7000-fold) after four weeks of treatment, corresponding to a 99.98% reduction in circulating virus. LdT treatment was very well tolerated. All patients completed the study, and the reported adverse events (potential side effects) were mild and the incidence of such events for all dose groups was similar to patients taking placebo. As a result of the increasing antiviral activity observed with increasing doses of LdT, and the observation of only minimal side effects, Novirio has amended the study to add an additional patient cohort to determine whether higher doses of LdT will yield even greater antiviral effects.

The results of this study, which will also be presented on Wednesday, December 19, at the Frontiers in Drug Development for Viral Hepatitis (HEP DART) in Hawaii, suggest that LdT has unprecedented antiviral effects and excellent safety in hepatitis B patients. "These findings are likely to translate into substantial clinical benefits when LdT is tested in larger studies of longer duration," commented Nathaniel Brown, M.D., Novirio's Senior Vice President of Hepatitis Clinical Research who presented the study. "The potent antiviral activity of LdT should lead to higher durable response rates and will help minimize the emergence of drug resistant virus strains."

LdT is a potent and selective nucleoside exhibiting specific activity against HBV replication in laboratory assays, and an excellent safety profile in preclinical testing. Novirio recently initiated a second LdT clinical trial, a larger one-year phase IIb study, in North America, Europe and in Asia. Phase III trials of LdT are being planned in conjunction with Sumitomo Pharmaceuticals Co., Ltd, Novirio's commercial partner for LdT in Japan, China, South Korea and Taiwan. Both studies are part of a global clinical development plan being conducted under the new International Conference on Harmonisation (ICH) Guidelines that aim to standardize clinical development and registration requirements in Europe, Japan and the United States. "Our goal is to make this important new treatment available as rapidly as possible to HBV-infected patients around the world," said Jean-Pierre Sommadossi, Ph.D., Chairman and CEO of Novirio. "We are pursuing a strategy to expedite regulatory submissions in key markets."

There are approximately 400 million people worldwide with chronic hepatitis B virus infection, about one-third of whom have potentially progressive and life-threatening liver disease associated with their chronic HBV infection. Chronic hepatitis B can lead to cirrhosis, liver failure, and hepatocellular carcinoma (liver cancer). Globally, hepatitis B accounts for over one million deaths annually, making it the ninth leading cause of death worldwide.

Novirio Pharmaceuticals Limited is a biopharmaceutical company focused on the discovery, development and commercialization of innovative treatments for life-threatening human viral diseases. The Company's principal disease targets are hepatitis B virus (HBV), hepatitis C virus (HCV) and HIV/AIDS. Novirio's programs are focused on the development of drug candidates, which, individually or as part of combination therapy, will offer significant improvements over currently approved treatments.

Contact: Novirio Pharmaceuticals, Inc. Noonan/Russo Communications, Inc. (617) 250-3116 (212) 696-4455 David Franklin Olaf Soltau (investor) ext. 232 VP Commercial Operations Lynn Blenkhorn (media) ext. 241

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