Vertex abandons hep C drug
pharmafile | September 27, 2012 | News story | Research and Development, Sales and Marketing | Alios BioPharma, Vertex, hep C
Vertex Pharmaceutical’s pipeline has been dealt a blow with the abandonment of an investigational hepatitis C compound.
The US firm, which was developing the drug with Alios BioPharma, said seven days of dosing with up to 900 mg of ALS-2158 was well-tolerated in people with genotype 1 chronic hepatitis C.
However, the company said there was “insufficient antiviral activity to warrant proceeding” with further clinical development of the adenosine nucleotide analogue.
Another of its hepatitis C drugs, called ALS-2200, appears more promising and the company said it was looking to move to mid-stage trials shortly.
“We’re making good progress and expect to begin all-oral Phase II combination studies by the end of this year,” said Robert Kauffman, chief medical officer at Vertex.
Vertex plans to look at the uridine nucleotide analogue in two studies with two different drugs: Incivek (telaprevir), its own approved protease inhibitor for hep C patients, and Roche’s Copegus (ribavirin).
The primary endpoint will be SVR12 (sustained viral response: undetectable hepatitis C virus 12 weeks after the end of treatment) in people with genotype 1 chronic hepatitis C.
New data from an additional cohort of an ongoing viral kinetic study of ALS-2200 added to ribavirin showed a median 4.18 log reduction from baseline in HCV RNA after seven days of dosing with a once-daily 200 mg dose of ALS-2200 in treatment-naïve patients.
ALS-2200 appears to have a high barrier to drug resistance based on in vitro studies and is designed to inhibit the replication of the hepatitis C virus by acting on the NS5B polymerase.
Data from the study will be presented at The Liver Meeting, the 63rd Annual Meeting of the American Association for the Study of Liver Diseases in Boston in November.
Vertex gained worldwide rights to ALS-2200 through an exclusive licensing agreement with Alios in June 2011.
Hepatitis C is an area in which many companies are attempting to develop drugs, although there are risks.
Last month Bristol-Myers Squibb admitted that the death of a patient was behind its decision to stop development of a potential treatment, the investigational nucleotide polymerase (NS5B) nucleotide BMS-986094.
Adam Hill
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