- Here are my notes from the Isis Pharma $ISIS presentation at the Bank of America Merrill Lynch Healthcare conference on 5/10/2011:
- ISIS company plan- stay small and remain focused on research thru p2 POC organization and then work with partners to bring drugs to market
- EU mipo filing in July and FDA thereafter based on four phase 3 postive trials. >700 pts, >100 on treatment over a year
- Select mipo-related slides from the deck have been added to the ISIS research page
- Mipomersen side effect profile is appropriate for these high risk pts
- 8% persisten increase in ALT liver enzyme lvels-some increase is normal for any lipid lowering therapy (and correlates with drug effect). This is monitorable and managable. Increases in liver fat plateau or decrease w/ monitoring over time
- Similar dropout rate to other 6 month subQ therapies
- With SNY/GENZ will start 12 month study this year
- 24 pipeline pgms- each have a lead drug at least initiating IND supporting packages...less than 1 yr to clinical trials...does not include research programs
- ApoC-III will enter p2 late 2011 or early 2012
- FXI will enter p2 late 2011 or early 2012
- PCSK9 moving forward towards clinic
- FGFR4 will enter p1 late 2011 or early 2012
- LLY (survivin inhibitor) p2 finishing up, data 2011 or early 2012
- STAT3 p1 late 2011 or early 2012
- Neurological diseases- have a large research pgm behind this small pipeline
- SOD1 will enter p2 2011
- SMN will start p1 very shortly
- Re EXC 001 -scar revision is a potentially very large market. If a patient scars the first time, doctors don't like to do revision surgery because the pt is likely to scar again the 2nd time
- ISIS will add 3-5 new drugs to pipeline in 2011, including at least one w/ generation 2.5 chemistry (have not yet announced which target or indication)
- q&a session:
- 2.5 chemistry -makes drugs bind more tightly to mRNA target and bind for longer time
- Mipomersen and PCSK9 aim for overlapping population. most severe patients would be mipomersen pts, but high risk pool of pts could use both drugs to get towards cholesterol goal level
- The setbacks to the 3 leading obesity drugs unrelated to antisense drugs (ie, CNS toxicity), is a positive for ISIS. Know that FDA will have a high safety threshold.
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