Thu Jan 6, 2011 7:48am EST
* PSI-7977 shows rapid viral suppression
* PSI-938 found to be well tolerated
Jan 6 (Reuters) - Pharmasset Inc (VRUS.O) said interim analyses of clinical studies of its two drugs for chronic hepatitis C showed promise.
A mid-stage study of the drug, codenamed PSI-7977, showed rapid viral suppression with all patients remaining below limit of detection at the end of treatment. No serious adverse events were reported.
The drug was granted "fast track" designation in August. Fast-track status is designed to expedite the review of drugs to treat serious diseases and fill unmet medical needs. [id:nSGE67B0JZ]
The company said it expects to start a 24-week mid-stage study of the drug in the second quarter of 2011.
An early-stage study of the drug, codenamed PSI-938, as a monotherapy was found to be safe and well-tolerated, Pharmasset said.
The Princeton, New Jersey-based company's shares, which have risen 50 percent in the last three months, closed at $46.59 on Wednesday on Nasdaq. (Reporting by Shravya Jain in Bangalore; Editing by Sriraj Kalluvila)
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Thursday, January 06, 2011
Pharmasset Reports Interim Study Results For Its Hepatitis C Drugs
Pharmasset (NASDAQ:VRUS) announced today interim results for the Phase 2b study for its PSI-7977 drug and the Phase 1 study for its PSI-938 drug. Both drugs are designed to treat Hepatitis C.
The Phase 2b study consisted of evaluating the effects of various PSI-7977 dosages in patients with Hepatitis C genotype 1, 2 or 3. The patients also received antiviral drugs commonly used to fight Hepatitis C.
Hepatitis genotype 1 patients received dosages of PSI-7977 and antiviral drugs over a 12-week period followed by 12 or 36 weeks of just antiviral drugs. Heptatitis genotype 2 and 3 patients received dosages of PSI-7977 and antiviral drugs over 12 weeks with no therapy afterward.
For the patients with Hepatitis C genotype 2 or 3, the data shows no serious adverse events and no discontinuations due to adverse events, the New Jersey-based company said. All patients showed viral suppression.
Results for the patients with Hepatitis C genotype 1 will be released in the second quarter of 2011, the company said.
During the second quarter of 2011, the company also expect to initiate a 24-week Phase 2b study of PSI-7977 with pegylated interferon and ribavirin.
In a separate Phase 1 study, the company also tested the PSI-938, a Hepatitis drug in a different chemical form than the PSI-7977.
Over a period of 14 days, patients were given dosages of only PSI-938 and showed no serious adverse events as well as no dose modifications or discontinuations, the company said. Also, the patients did not see an increase in the severity of viral infection while on therapy.
PSI-938 will also be tested in combination with PSI-7977, with the results scheduled to be reported sometime this quarter.
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