NATAP - Vertex Nuke Program ALS-2200

Vertex Nuke Program ALS-2200

Published today by National AIDS Treatment Advocacy Project

NATAP has provided us with a news archive (Sept-July) on the nucleotide polymerase inhibitor (nuke) - ALS2200, including a summarized report from Y. Katherine Xu, a New York-based analyst at William Blair, click here to read the full article.

ALS2158 Discontinued Because of Lack of Efficacy; ALS2200 Pushes Into Phase II studies

Y. Katherine Xu, Ph.D.

William Blair Stock Analysts

Excerpt: 

Combo of ALS2200 plus ribavirin delivers similar antiviral activity (4.18 log) to previously reported ALS2200 monotherapy (4.54 log, exhibit 1). Previously, only a purine-based nuke BMS094 (INX189, discontinued) demonstrated antiviral synergy with ribavirin in a seven-day study because ribavirin is a purine-based nuke as well. As ALS2200 is pyrimidine-based, it is not expected to demonstrate antiviral synergy with ribavirin in a ...........
 

Phase III studies are possible to start before year-end 2013, a timeline that could positions Vertex well in the HCV race for all-oral regimens. Vertex plans to initiate Phase III studies of oral regimens in parallel, likely before year end 2013. Should this timeline be achieved, Vertex would be among the front runners in the race of all-oral regimens. The composition of the regimen(s) to be taken into Phase III depends on data to be obtained over the next 12-15 months............

 

Vertex Nucleotide Analysis- (08/01/12)

Monday July 30 after markets closed, Vertex reported the long-anticipated viral kinetic data from one of the two Alios nukes. In a monotherapy study in genotype 1 (GT-1) patients, ALS-2200 demonstrated initial potency that appears to match that of GS-7977, the current nuke class leader. Should 12-week safety of ALS-2200 hold up, ALS-2200 could serve as a backbone for Vertex's future all-oral combination regimens, and put Vertex in position to initiate Phase III studies by year-end 2013. We summarize the ALS-2200 data together with other nukes in exhibit 1.

 

Vertex Announces Positive Results from Viral Kinetic Study of the Nucleotide Analogue ALS-2200 in People with Hepatitis C - (07/30/12)

 

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and its collaborator Alios BioPharma, Inc. today announced positive results from a viral kinetic study of the nucleotide analogue ALS-2200 for the treatment of hepatitis C. There was a median 4.54 log10 reduction in hepatitis C virus (HCV) RNA in people with genotype 1 chronic hepatitis C who were new to treatment (n=8) after seven days of dosing with 200 mg of ALS-2200 once daily. ALS-2200 was well-tolerated in this study, and no patients discontinued due to adverse events. Based on these data, Vertex plans to begin Phase 2 studies this year of 12-week all-oral regimens including ALS-2200 in people with genotype 1 hepatitis C, pending discussions with regulatory agencies

 

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