Vertex Pharmaceuticals Inc. (NASDAQ: VRTX) announced positive interim results on Wednesday from a Phase 2 two-part study of 'telaprevir' combination therapy for treatment of hepatitis C virus and human immunodeficiency virus, also known as HCV-HIV co-infection.
According to the results, Vertex's hepatitis C drug telaprevir helped eliminate the virus in 70 percent of patients who were also infected with HIV. The positive results was seen in trading of Vertex stock that had reached a new high for fourth time from last week. The shares of the drugmaker touched a new 52-week high of $47.82 on Wednesday.
The Cambridge, Massachusetts-based Vertex said 70 percent of people in the study who received telaprevir-based combination therapy had undetectable hepatitis C virus by week 4 compared to 5 percent of people who received pegylated-interferon and ribavirin alone. HIV viral load and CD4 counts were stable among patients receiving a telaprevir-based regimen.
The Phase 2 two-part (A,B) trial evaluated telaprevir in combination with pegylated-interferon and ribavirin compared to pegylated-interferon and ribavirin alone Part for treating HCV-HIV co- infection.
The primary endpoint of the study is to evaluate the safety and tolerability of telaprevir-based combination therapy in people co-infected with hepatitis C and HIV. Data from the co-infection study were presented at the 18th Conference on Retroviruses and Opportunistic Infections in Boston.
Part A of the study is evaluating telaprevir in people who are not currently being treated with antiretroviral therapy for HIV infection. Part B of the study is evaluating telaprevir in people receiving Atripla or a Reyataz-based regimen for HIV.
Adverse events that occurred more frequently in the telaprevir arms compared to placebo were pruritus, nausea, dizziness, pyrexia, anorexia and vomiting. The majority of adverse events were mild or moderate.
The midstage two-part study is a randomized, double-blind, placebo-controlled, parallel group, multi-center trial in people chronically infected with both genotype 1 hepatitis C virus and human immunodeficiency virus who were new to hepatitis C treatment. The study enrolled 60 people.
Telaprevir is awaiting a U.S. approval decision after demonstrating an ability to greatly improve hepatitis cure rates when combined with current standard of care medicines compared with those drugs alone.
Vertex is developing telaprevir in collaboration with Tibotec BVBA and Mitsubishi Tanabe Pharma. Vertex has rights to commercialize telaprevir in North America. Tibotec, through its affiliate Janssen, has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries.
Vertex stock touched a new 52-week high of $44.68 on Feb. 23 as it announced positive results from a late-stage STRIVE study of its oral drug VX-770 for treatment of cystic fibrosis, a genetic disease that impairs the lung.
On Feb. 25, the stock surpassed Feb. 23 high to reach a new 52-week high of $44.98. But on Feb. 28, the stock surpassed Feb. 25 high to reach a new 52-week high of $46.75, on positive cystic fibrosis study.
Due to positive interim results from Vertex's hepatitis C drug telaprevir study, the stock touched a new 52-week high of $47.82 during the Wednesday's trading session. The stock closed Wednesday's regular trading up 2.68 percent at $47.28 on a volume of 2.87 million shares on the NASDAQ stock market. The stock traded between $31.25 and $47.82.