Mixed Results from Vertex Studies
Vertex Pharmaceuticals Incorporated (VRTX) and its partner, Alios BioPharma, Inc. recently announced disappointing results from a viral kinetic study evaluating ALS-2158 which is being developed for the treatment of patients suffering from hepatitis C virus (:HCV).
In the study, patients suffering from genotype 1 chronic hepatitis C were dosed with up to 900 mg of ALS-2158 for seven days. Though the candidate was well tolerated, antiviral activity demonstrated in the study was not enough to support further development of the candidate. As a result, Vertex decided to stop further clinical development of the candidate.
On the other hand, Vertex presented positive data from an additional cohort of another ongoing viral kinetic study evaluating ALS-2200 along with ribavirin. The study was evaluating the combination to treat patients suffering from genotype 1 chronic hepatitis C virus.
Data from the study revealed that ALS-2200 along with ribavirin resulted in five patients achieving HCV RNA levels below the limit of qualification after seven days of treatment. The study also showed that in two of these five patients, HCV RNA levels were below the level of detection in the same period of time. Vertex also mentioned that ALS-2200 was well tolerated with no discontinuation due to adverse events.
The company plans to initiate several oral phase II combination studies by this year. Initially, Vertex is planning to conduct phase II studies with ALS-2200, one in combination with ribavirin and another in combination with Incivek (telaprevir) for patients suffering from genotype 1 chronic hepatitis C virus. We note that Incivek is already approved for the treatment of genotype 1 chronic hepatitis C and is marketed globally.
Notably, in June last year, Vertex signed an exclusive licensing agreement with Alios BioPharma to gain the worldwide rights to ALS-2200.
The HCV market is very lucrative and currently has players like Merck & Co. Inc. (MRK) and Gilead Sciences Inc. (GILD).
Our Recommendation
We currently have a Neutral recommendation on Vertex. The stock carries a Zacks #4 Rank (Sell rating) in the short run.
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