Vertex Pharmaceuticals Inc. (VRTX) recently received a notice from the U.S. Food and Drug Administration (FDA) informing the company about a partial clinical hold on Vertex Pharma’s ongoing phase II U.S. study of its hepatitis C virus (HCV) candidate, VX-135. The news had a negative impact on the company’s stock price.
Vertex Pharma discontinued the 400 mg arm of the phase II study of VX-135 in combination with ribavirin in Europe as elevated liver enzymes were observed. Following this observation, the FDA put a clinical hold on the 200 mg dose of VX-135 in combination with ribavirin in a study in the U.S. The FDA has asked Vertex Pharma to submit additional clinical, preclinical and pharmacokinetic data in the fourth quarter. VX-135 is also being evaluated in a 100 mg dose in combination with ribavirin in a study in the U.S. This study will be continued as planned and data is expected in the second half of 2013.
Besides this, Vertex Pharma also provided updates on other all-oral studies conducted on VX-135.
Dosing of 100 mg and 200 mg of VX-135 in combination with ribavirin as part of the 12-week, phase II study in Europe was recently completed. Both doses were well tolerated with no serious adverse events identified. Complete data is expected by Dec 31, 2013.
Recently, as part of a phase II study, in New Zealand, 100 mg and 200 mg doses of VX-135 in combination with Bristol-Myers Squibb’s (BMY) daclatasvir were initiated. Data from this study is expected in early 2014.
VX-135 is also being evaluated in a drug-drug interaction clinical study in combination with Johnson & Johnson’s (JNJ) simeprevir.
Vertex Pharma carries a Zacks Rank #3 (Hold). Right now, Jazz Pharmaceuticals Public Limited Company (JAZZ) looks well positioned with a Zacks Rank #1 (Strong Buy).
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