Development

Phase IIb clinical trial of Sifuvirtide achieves improvement in efficacy

(chinadaily.com.cn)
Updated: 2010-08-09 17:53

FusoGen Pharmaceuticals, Inc. has recently completed phase IIb clinical trial of Sifuvirtide, a novel HIV fusion inhibitor developed in China.

On August 1, 2010, a symposium on Sifuvirtide & phase IIb clinical summary was held in Beijing. Scientists from leading HIV/AIDS research centers, such as the New York Blood Center and the University of Lisbon, and clinical experts from HIV/AIDS treatment centers, such as the Beijing You’an Hospital and the Beijing Ditan Hospital, exchanged and discussed some breakthrough results in basic research and clinical trials about Sifuvirtide.

Sifuvirtide, which was designed based on the 3D structure of HIV gp41, is the best of class in fusion inhibitors. The compound patent for Sifuvirtide has been issued in China, USA, and Europe. There are 10 scientific articles about Sifuvirtide published in peer review international journals.

With supports from the Ministry of Science and Technology, SFDA and the Tianjin Committee of Science and Technology, FusoGen has completed phase Ia, Ib, IIa and IIb clinical trials of Sifuvirtide with compliance to GCP standard. Over 200 subjects were enrolled in these four studies. Sifuvirtide has good safety profiles. For monotherapy, the efficacy of 20 mg of Sifuvirtide once daily was equivalent to that of 100 mg of T20 twice daily, the first fusion inhibitor developed in the USA. For combination therapy with other antiretroviral agents in IIb clinical trial, Sifuvirtide could substantially improve the efficacy over traditional treatment. After 24 week administration, the rate of undetectable viral loads and the rate of CD4 cell count increments for the Sifuvirtide group is 59% and 89% better than that for the control group, respectively. The injection site reaction is 7% for Sifuvirtide comparing 98% for T20.