Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.
PRNewswire - October 30, 2000
The 24 week, double-blind, randomized trial compared the anti-HBV activity of Coviracil in doses of 25 mg once daily (qd), 100mg qd, and 200mg qd. Ninety eight patients with chronic HBV infection participated in the trial and were distributed equally among the three treatment regimens. At 24 weeks, all treatment doses showed significant anti-HBV activity. Median reductions in viral load from baseline of 2.3 log10, 2.9 log10, and 3.0 log10 were observed for the 25 mg, 100 mg, and 200 mg qd regimens, respectively. HBV DNA was suppressed below the limit of detection (4700 copies/mL) in 61%, 24%, and 22% of the patients receiving 200 mg, 100 mg, and 25 mg qd, respectively.
Therefore, the 200 mg qd dosage was selected as the optimal dose for a Phase III trial, which was initiated this month. Coviracil was generally well tolerated over the 24 week study.
"The excellent anti-HBV activity of Coviracil at 200 mg qd, coupled with the good tolerability profile observed over 24 weeks in patients with existing hepatic disease, suggests that Coviracil has the potential to be useful for the treatment of HBV and warrants further studies to define its full effect in chronic HBV infection," stated Dr. Franck Rousseau, Executive Vice President of Medical Affairs and Chief Medical Officer of Triangle Pharmaceuticals, Inc.
Triangle Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the development of new antiviral drug candidates, with a particular focus on therapies for the human immunodeficiency virus (HIV), including the acquired immunodeficiency syndrome (AIDS), the hepatitis B virus (HBV) and hepatitis C virus (HCV). Triangle's proprietary drug candidates under development for HIV and/or HBV include Coviracil(R) (emtricitabine), Coactinon(R) (emivirine), DAPD, clevudine (formerly L-FMAU) and mozenavir (formerly DMP-450). Triangle is also developing immunotherapies for HIV, HBV and HCV in collaboration with Dynavax Technologies Corporation (Dynavax) utilizing Dynavax' immunostimulatory sequence (ISS) technology. More information about Triangle's portfolio, management and product development strategy is available on Triangle's website at: http://www.tripharm.com.
Statements in this press release that are not historical facts are forward-looking statements and are subject to numerous risks and uncertainties, including the risk that the Company could fail to successfully complete pivotal clinical trials or that such trials could be halted or terminated by regulatory authorities, the Company's future capital needs, the inability to commercialize Coviracil, DAPD and ISS-based therapies due to patent rights held by third parties, the Company's ability to obtain additional funding (including contingent contractual milestone payments), patent protection and required regulatory approvals for its drug candidates, the development of competitive products by others, the cost of coactive therapy and the extent to which coactive therapy achieves market acceptance, the Company's success in identifying new drug candidates, acquiring rights to the candidates on favorable terms and developing any candidates to which the Company acquires any rights, that the Company's collaborations with third parties may not prove successful and these and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. As a result of these and other risks and uncertainties, actual results may differ materially from those predicted in this press release. The Company disclaims any obligations to update any forward-looking statements in this press release.
Robin Fastenau Director of Investor Relations Triangle Pharmaceuticals, Inc. (919) 493-5980 http://www.tripharm.com
Douglas MacDougall Kari Lampka Feinstein Kean Healthcare (617) 577-8110 http://www.fkhealth.com
SOURCE Triangle Pharmaceuticals, Inc. Web Site: http://www.tripharm.com
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