re: idix and smith barney
>> latest data show disparity in undetectable viral load of 15% between nm-283+peg vs peg-ribavirin (favoring nm-283). We have yet to know how this spread will translate to differences in svr, but i figure should be mroe or less the same. <<
I hope you're right about this but I won't feel confident till I see some SVR data , even if only 3-month , that supports the notion that on-treatment HCV-negativity translates to eventual SVR at similar rates for NM283 plus pegifn as it does for riba plus pegifn. In order for end-of-treatment HCV-negativity to result in SVR , it's generally believed that the immune response must be functioning properly and many think that riba contributes to the necessary 'resetting' of the immune response , something that hasn't been suggested for NM283. VX950 might have a better shot in a riba-free tx. , since it does presumably help correct the disruption in ifn signalling caused by the HCV protease.
Assuming the in-vivo studies do show a significant negative interaction between riba and NM283 , I think they should try a two-stage tx. regimen to avoid the total loss of riba's benefit. For example , 24 weeks of NM283 plus pegifn followed by 24 wks of pegifn plus riba ( +/- NM283 , depending on whether they believe NM283 would add any benefit in the second stage ). This might complicate a P3 trial , since I assume the FDA would want to see the corresponding placebo control arm , in addition to the regular SOC control arm. Ideally this would have been examined in P2 trials ; maybe the current studies have some arms like this.
Although I agree with the gist of the SB report as regards NM283 , I don't agree with this :
>> We caution that the stock could be volatile to downside if this interaction is shown in the current 90-patient clinical study when data is released in Q1:07 since this could lead to termination of further development efforts of NM283 <<
NM283 can still make a splash if it's the first polymerase inhibitor to market , even if it's way behind VX950 in efficacy. The reason is that there will be the opportunity to try combos of the two drugs (NM283 and VX950 ) , each with new and different MOAs , with the potential to greatly reduce or eliminate the need for BOTH riba and pegifn. I don't think NVS / IDIX will give up on NM283 , even in the face of unfavorable drug-drug interaction results with riba ( as long as they think they can design a successful P3 ).
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AI
