Saturday, April 25, 2009 8:13:06 PM
INFORM:
I was a little disappointed in the higher dosing groups not appearing to have a greater impact on viral load reduction. The overall BLQ looked quite good and BLD was also encouraging especially considering its 14 days and such low 191 doses were used. Dr. Gane made the point that in the highest cohort 2 who were not BLD were at 15 and (I believe) 17 and he thought in the next couple days would have been so that is basically 50% BLD in the highest dose cohort. The slopes of the curve seemed encouraging as well. Certainly way outside my realm so to call it a guess I would think based on the low dose efficacy adding a third, fourth agent may be the most promising route for all oral and sticking with the low dose. Of note 191 is a macrocyclic protease inhibitor.
Some brief notes from the PR/Call/Presentation:
. Baseline viral loads had to be > 5 logs
. .6 log better (at least early low dose groups) synergy of two compounds (then each alone added together).
. Over 2/3 BLQ at day 14 (part of reason given for 3 higher treatment groups having similar viral load reduction curves).
. Safety profile quite good (no grade 3 AE’s and type and degree not substantially different across cohorts).
. Going forward 3 more cohorts planned for INFORM-1 (talked about formulation being more convenient but didn’t quite catch it).
1) 8 active 2 placebo (Treatment failure, NOT Null Responders) 1000 mg BID 7128, 600 mg BID 7227
2) 8 active 2 placebo (Null Responders) 1000 mg BID 7128, 900 mg BID 7227
3) 8 active 2 1000 mg BID 7128, 900 mg BID 7227
. Some things to be careful about in over interpreting small samples. It was pointed out the baseline viral load in 1 of high dose was lower so likely skewed the data somewhat in that cohort
. Discussions about formal joint guidelines being developed (but nothing given to companies yet) about further developing combination. Think intrigued but want to be cautious. In active discussions to move beyond 14 days.
. Asked about warehousing and what SVR (only considering that) would make decision easier and thought 10% incremental improvement. Also thought treatment failures (depending on stage of disease) would be more likely to wait for this type of regimen.
. Roche open in longer term to explore adding other therapies (not under their control).
. Absolutely will consider 4 drug (adding SOC). Think some degree of customization will be the norm. Think 4 drug would likely be in the more difficult to treat (failures).
. Breakthrough was in low dose group (quickly suppressed after addition of SOC) and remains undetectable. Had .5 log increase (considered breakthrough).
The full slide presentation is available on InterMune’s website at:
http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9MzIzMnxDaGlsZElEPS0xfFR5cGU9Mw==&t=1
This slide shows the Viral load reductions in the various cohorts presented.
I was a little disappointed in the higher dosing groups not appearing to have a greater impact on viral load reduction. The overall BLQ looked quite good and BLD was also encouraging especially considering its 14 days and such low 191 doses were used. Dr. Gane made the point that in the highest cohort 2 who were not BLD were at 15 and (I believe) 17 and he thought in the next couple days would have been so that is basically 50% BLD in the highest dose cohort. The slopes of the curve seemed encouraging as well. Certainly way outside my realm so to call it a guess I would think based on the low dose efficacy adding a third, fourth agent may be the most promising route for all oral and sticking with the low dose. Of note 191 is a macrocyclic protease inhibitor.
Some brief notes from the PR/Call/Presentation:
. Baseline viral loads had to be > 5 logs
. .6 log better (at least early low dose groups) synergy of two compounds (then each alone added together).
. Over 2/3 BLQ at day 14 (part of reason given for 3 higher treatment groups having similar viral load reduction curves).
. Safety profile quite good (no grade 3 AE’s and type and degree not substantially different across cohorts).
. Going forward 3 more cohorts planned for INFORM-1 (talked about formulation being more convenient but didn’t quite catch it).
1) 8 active 2 placebo (Treatment failure, NOT Null Responders) 1000 mg BID 7128, 600 mg BID 7227
2) 8 active 2 placebo (Null Responders) 1000 mg BID 7128, 900 mg BID 7227
3) 8 active 2 1000 mg BID 7128, 900 mg BID 7227
. Some things to be careful about in over interpreting small samples. It was pointed out the baseline viral load in 1 of high dose was lower so likely skewed the data somewhat in that cohort
. Discussions about formal joint guidelines being developed (but nothing given to companies yet) about further developing combination. Think intrigued but want to be cautious. In active discussions to move beyond 14 days.
. Asked about warehousing and what SVR (only considering that) would make decision easier and thought 10% incremental improvement. Also thought treatment failures (depending on stage of disease) would be more likely to wait for this type of regimen.
. Roche open in longer term to explore adding other therapies (not under their control).
. Absolutely will consider 4 drug (adding SOC). Think some degree of customization will be the norm. Think 4 drug would likely be in the more difficult to treat (failures).
. Breakthrough was in low dose group (quickly suppressed after addition of SOC) and remains undetectable. Had .5 log increase (considered breakthrough).
The full slide presentation is available on InterMune’s website at:
http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9MzIzMnxDaGlsZElEPS0xfFR5cGU9Mw==&t=1
This slide shows the Viral load reductions in the various cohorts presented.
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