>IDIX – what do you think the path forward and timeline for IDX899 is likely to be?<
Please see the graphic in #msg-26915885. After the phase-2 trial shown in yellow is completed (provided of course that it’s successful), IDIX will seek a development and commercialization partner.
Under the terms of the relationship between IDIX and NVS, there will be a 90-day window following completion of the phase-2 trial during which NVS has an exclusive option to negotiate a license with IDIX for worldwide development and commercialization. If a license is consummated, NVS will fund all remaining phase-2 and phase-3 development and will pay IDIX clinical and regulatory milestones. IDIX, in turn, has the option to co-promote and split profits with NVS in the US, Germany, France, UK, Italy, and Spain. (If IDIX declines this option, it will receive royalties from NVS in the above countries.) In all other countries, NVS will have exclusive commercialization rights and will pay IDIX royalties.
If NVS does not exercise its option to pursue an IDX899 license during the 90-day window, IDIX is then free to strike a deal with another partner. (Inasmuch as NVS currently has no presence in the HIV arena, it’s not crazy to think that NVS may pass on its option even if the IDX899 data are compelling.)
>Assuming a partnership is done, would they commence a P3 for IDX899 alone or immediately do a combination study.<
The phase-2b and phase-3 studies will surely employ combination regimens. (It would be unethical to give AIDS patients anything less.) The most likely design, IMO, is the same as the one to be employed in the first phase-2 study: IDX899+Truvada vs Sustiva+Truvada in first-line (and possibly second-line) patients. The main difference between the phase-3 and the phase-2 studies is, of course, that the phase-3 studies will be larger and longer.
Depending on the breadth of the phase-3 program (i.e. depending on how much money IDIX’s partner wants to spend on development), other studies may be run to test IDX899+Truvada vs Reyataz+Truvada and/or Kaletra+Truvada. Additional studies may be restricted to the second-line setting or to special patient populations (e.g. HIV/HCV co-infection).
Let’s talk biotech! “The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
>I haven't followed HIV drugs before, so would appreciate some info on the typical P3 duration and endpoints.<
The main efficacy endpoint in late-stage HIV studies is typically the proportion of patients who achieve and maintain viral load below a pre-specified threshold (e.g. 400 copies/ml of plasma). Typical secondary endpoints include: a) the proportion of patients who reach a more stringent viral-load threshold (e.g. 50 copies/ml); and b) the mean increase relative to baseline in CD4 cell count.
The primary efficacy endpoint is typically evaluated at 48 weeks, but it may be done at 96 weeks or even 144 weeks. In any case, patients in phase-3 trials are generally followed for at least 144 weeks to evaluate safety.
Unlike trials in HCV, which evaluate the proportion of patients who are cured of their disease, HIV trials merely seek to show whether the virus can be held in check. Thus, there is no HIV endpoint that is comparable to the sustained virologic response (SVR) endpoint that is universally employed in late-stage HCV trials.
>Seems to me that not that many patients are required given the clear impact of the drug.<
Absolutely correct––this is the beauty of drug development in the antiviral arena. You find out very early whether or not a drug has efficacy at suppressing viral replication. By the time an antiviral drug gets into phase-2, there is usually little question about its efficacy, and hence the rest of the clinical-development program seeks to determine safety, tolerability, and (in the case of non-curable conditions such as HIV) cross-resistance to therapies that may have to be used later on.
Let’s talk biotech! “The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
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