Replies to post #95154 on Biotech Values

[go seek]

IDIX: I agree. JP did not have to say it... yet he did.
IDIX would not have made such a bold move w/o a nod from NVS.

Plus the partner(s) IDIX is negotiating with wants to see this combination trial, as much as IDIX does.

You and I have been listened to enough IDIX CC's to know "the story" ...by reading between the lines.

It is a very exciting time for IDIX and IDIX shareholders.


We continue to have discussions with potential corporate partners on the IDX184 program and remain optimistic about our prospect for securing partnership for this program this year.

We are also very excited about the pre-clinical and clinical data observed with IDX320, our HCV protease inhibitor. Based on the in vitro potency seen in the replicon model combined with multi-genotypic coverage and the potential for once-daily dosing suggested by its PK profile in the phase I study that was presented at EASL. We hope that IDX320 may offer substantial improvements over all the protease inhibitors.

Based on the emerging profiles of IDX184 and IDX320, we intend to accelerate our timeline for evaluating these two direct acting antiviral drug candidates. Subject to discussions with regulatory authorities, our plan is to conduct, first, a drug-drug interaction study of IDX184 and IDX320 in healthy volunteers and then to initiate a combination study in HCV-infected patients in the second half of this year. JP Sommadossi, CEO

[DewDiligence]

IDIX’s drug-drug-interaction study of IDX184+IDX320 is close to dosing the first subject insofar as clinicaltrials.gov (as of Jul 2) now has an entry for this trial at http://clinicaltrials.gov/ct2/show/NCT01157104 . (Thanks to the new iHub poster, delmar512, for this find.) I expect IDIX to issue a PR when the first subject in this trial has been dosed.

The trial design is typical for a 2-drug DDI study. In each of two 8-subject cohorts, subjects take IDX184 or IDX320 monotherapy in the first week and switch to IDX184+IDX320 combination therapy in the second week; this design allows the PK/PD of the drug combination to be distinguished from the PK/PD of each drug individually.

During the one-week monotherapy period, subjects receive a lookalike placebo for the drug they are not taking, which enables the subjects and clinicians to be blinded from the treatment protocol of a given subject. Each of the two cohorts also has two subjects who take placebos throughout the 2-week dosing period, which means there are 20 subjects in all (2x(8+2)).

Viral resistance is a non-issue in this trial because the subjects are healthy volunteers, not HCV patients.

The one trial center already listed at clinicaltrials.gov is in Lincoln, NE, which is where the main campus of University of Nebraska is located. College students are presumably a good source of volunteers for these kinds of studies.

Please see #msg-49731578 and #msg-49732533 for background info on where all-oral IDX184+IDX320 combination treatment fits into IDIX’s plans in the HCV arena.