AI
Friday, April 16, 2010 7:51:18 AM
ITMN:
I thought the results of the boosting study were impressive. The overall number of 72% below detection and 100% in the 200mg BID have to be among the highest seen in the 2 week treatment period. Unfortunately like Dew has pointed out the results would be much more impressive had the drug not been tainted by the Grade 4 tox in the higher dose of the 2B study. It may turn out the they never even needed to go that high and my sense is they won't make the same mistake with the boosting 2B.
The amend arms of the 1B boosting study are quite interesting IMO. It could be signaling a strategy Roche may be taking to enter the market. Given that in the treatment naive they are probably ~3 years behind and even the treatment failures have some data the null responder market may have an opportunity to enter the market quicker and may not be penetrated by anyone when (or if) the drug reaches the market place or if the data are impressive patients may wait over existing options. Also the fact that they are going with the 100mg BID and 200mg QD in this harder to treat patient population may be a sign they believe in 12 weeks there is no need to risk tox with a higher dose from what they have seen of the viral load curves.
The timing of initiation for INFORM-3 (the second INFORM study) is also interesting as I believe a couple of things could develop leading to the vague timeline (of course a pessimist would think the vague timeline may be a signal of its demise
). The 12 week null responder arms could be an indication they will examine that in more detail in that study. Also if QD continues to look impressive maybe Roche would license Pharmasset's more potent PSI-7977? Those two compounds would appear to be on a similar timeline with QD and lower doses (than 191 and RG7128) and would give them something novel if that combo would reach the marketplace.
I thought the results of the boosting study were impressive. The overall number of 72% below detection and 100% in the 200mg BID have to be among the highest seen in the 2 week treatment period. Unfortunately like Dew has pointed out the results would be much more impressive had the drug not been tainted by the Grade 4 tox in the higher dose of the 2B study. It may turn out the they never even needed to go that high and my sense is they won't make the same mistake with the boosting 2B.
The amend arms of the 1B boosting study are quite interesting IMO. It could be signaling a strategy Roche may be taking to enter the market. Given that in the treatment naive they are probably ~3 years behind and even the treatment failures have some data the null responder market may have an opportunity to enter the market quicker and may not be penetrated by anyone when (or if) the drug reaches the market place or if the data are impressive patients may wait over existing options. Also the fact that they are going with the 100mg BID and 200mg QD in this harder to treat patient population may be a sign they believe in 12 weeks there is no need to risk tox with a higher dose from what they have seen of the viral load curves.
The timing of initiation for INFORM-3 (the second INFORM study) is also interesting as I believe a couple of things could develop leading to the vague timeline (of course a pessimist would think the vague timeline may be a signal of its demise
). The 12 week null responder arms could be an indication they will examine that in more detail in that study. Also if QD continues to look impressive maybe Roche would license Pharmasset's more potent PSI-7977? Those two compounds would appear to be on a similar timeline with QD and lower doses (than 191 and RG7128) and would give them something novel if that combo would reach the marketplace.
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