The drug was well tolerated and demonstrated potent antiviral activity in a phase I clinical trial involving 34 patients with chronic genotype 1 hepatitis C virus infection. The participants were treated for 14 days with placebo or one of three dose regimens of VX-950 given at either eight or 12hour intervals.
All doses of the compound significantly reduced the amount of virus in the blood stream. Patients taking 750 mg every eight hours achieved the best results, showing a 10,000-fold decrease in viral levels at the end of 14 days of treatment.
While the drug is still years away from approval, the encouraging results pushed share prices up by 20%.
Vertex plans to explore the development of VX-950 as monotherapy and in combination with other HCV treatments, consulting with the FDA European regulatory authorities on development plans. In collaboration with Vertex, Mitsubishi Pharma Corporation is developing VX-950 in Japan and certain Far East countries.
If development plans succeed, the drug could become Vertex’s main product. Although Vertex was one of the first companies to achieve FDA approval for an HIV/AIDS protease inhibiting treatment, the company only receives 20% of royalties from the $165 million-a-year drug, which is marketed by GlaxoSmithKline.