Provided by NATAP
FOR IMMEDIATE RELEASE
IDENIX PHARMACEUTICALS REPORTS
THIRD QUARTER AND NINE MONTH 2013 FINANCIAL RESULTS
AND PROVIDES HCV PIPELINE UPDATE
- Enrollment initiated for a phase I/II clinical trial for IDX21437, a next-generation uridine nucleotide prodrug inhibitor for the treatment of hepatitis C virus infection (HCV)
- Initiation planned for HELIX-2 combination study in collaboration with Janssen Pharmaceuticals, Inc. including pan-genotypic HCV NS5A inhibitor, samatasvir
- Idenix to host conference call / webcast at 4:30 p.m. ET today
CAMBRIDGE, Mass., October 30, 2013 -- Idenix Pharmaceuticals, Inc. (NASDAQ: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today reported unaudited financial results for the third quarter ended September 30, 2013.
HCV Pipeline Review
Nucleotide Inhibitor Program
· IDX21437, a next-generation uridine nucleotide prodrug inhibitor, has received approval to enter clinical trials in Canada and Belgium. Idenix has initiated enrollment for the healthy volunteer portion of a phase I/II clinical trial. Extensive preclinical testing for IDX21437 demonstrated favorable antiviral activity across genotypes 1-6 and a safety profile which supported advancement into clinical trials.
· Idenix is conducting additional preclinical work as requested by the United States Food and Drug Administration for IDX20963, a uridine nucleotide prodrug candidate.
Samatasvir (IDX719), NS5A Inhibitor Program
All patients (n=63) have completed enrollment in Part A of the phase II 12-week HELIX-1 clinical trial evaluating an all-oral, direct-acting antiviral (DAA) HCV combination regimen of samatasvir, Idenix's once-daily pan-genotypic NS5A inhibitor, and simeprevir, a once-daily NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB, and ribavirin in treatment-naïve, non-cirrhotic, genotype 1b or 4 HCV-infected patients. SVR4 data for patients in Part A of the study are anticipated to be available in the fourth quarter of 2013. Part B of the ongoing HELIX-1 clinical trial includes exploratory cohorts which have been added to evaluate the safety and antiviral activity of a 25 mg dose of samatasvir in genotype 1b-infected patients and of a 100 mg dose of samatasvir in genotype 6-infected patients.
· Idenix is planning to initiate a second 12-week phase II clinical trial in collaboration with Janssen Pharmaceuticals, Inc., HELIX-2, which will evaluate the 3-DAA combination of samatasvir, simeprevir and TMC647055, a once-daily NS5B non-nucleoside polymerase inhibitor boosted with low-dose ritonavir being developed by Janssen R&D Ireland, with and without ribavirin in genotype 1-infected patients who are either treatment-naïve or have previously relapsed after treatment with pegylated interferon and ribavirin.
"A key objective for our development teams has been to commence a clinical trial for our nucleotide prodrug program this year," said Ron Renaud, Idenix's President and Chief Executive
Officer. "Based on the differentiated profile we've seen in our preclinical research, we believe IDX21437 has strong potential to be a key component of a fixed-dose all-oral pan-genotypic regimen, specifically in combination therapy with our NS5A inhibitor."
Mr. Renaud continued, "We are also pleased with the progress of the phase II program for samatasvir. The ongoing HELIX-1 study is building the safety and antiviral efficacy profile for samatasvir as part of a 12-week all-oral treatment regimen and supporting future combination studies, including the 3-DAA HELIX-2 study, as well as the evaluation of a pan-genotypic combination with IDX21437 in 2014."
CONFERENCE CALL AND WEBCAST INFORMATION
Idenix management will host a conference call at 4:30 p.m. ET today. To access the call, please dial (877) 640-9809 (U.S./Canada) or (914) 495-8528 (International) and enter passcode 90503423. A live webcast will be available through the Investor section of the Idenix website at www.idenix.com under "Events & Presentations". The archived webcast will be available for two weeks following the call on the Idenix website.
Idenix HCV Pipeline/ uridine nucleotide prodrug inhibitor IDX21437
Excerpted from yesterday's company conference call, seeking alpha.com: we're happy to tell you today that a novel next-generation uridine nucleotide prodrug inhibitor IDX21437 has received approval to enter clinical trials in both Canada and Belgium. Based on its promising early profile IDX21437 was selected as one of our lead drug candidates resulting from our comprehensive nucleotide discovery effort that we have been discussing over the past few years.
this is really our first public announcement. We've been working as you can imagine with done multiple passing with Ð first with 963, but we had this going on in parallel and we've talked about that we continue to look for other potent and safe nucleus type pro-drug candidates and that continues to go on as aggressively as we have ever been.
I'm pleased to report important progress with our HCV programs. First, we're happy to tell you today that a novel next-generation uridine nucleotide prodrug inhibitor IDX21437 has received approval to enter clinical trials in both Canada and Belgium. Based on its promising early profile IDX21437 was selected as one of our lead drug candidates resulting from our comprehensive nucleotide discovery effort that we have been discussing over the past few years.
Extensive preclinical testing demonstrated a clean safety profile including no cardiac or genotoxicity signals. This along with favorable antiviral activity across genotypes 1 through 6 supported the advanced of this compound into the clinic. We have initiated enrollment for the healthy volunteer portion of a Phase I/II study, which will evaluate the safety and pharmacokinetics of single doses of IDX21437 and we anticipate dosing to begin next week.
In parallel sequential single doses of IDX21437 will be administered to HCV infected patients. The single dose safety PK and antiviral activity will come from the selected doses for the seven-day proof-of-concept portion of the study which will evaluate patients in fact through genotypes 1 through 6 and cirrhotic HCV genotype 1 infected patients.
For IDX2963 an additional uridine nucleotide prodrug candidate we are conducting further preclinical work in response to the FDA's request related to the positive in vitro Ames test result observed in our IND enabling studies, prior to the initiation of clinical trials. A key objective for our development teams has been to commence a clinical trial for our nucleotide prodrug program this year.
With the rapidly evolving HCV treatment landscape, we know the bar for safety is high. And based on a differentiated and competitive profile we've seen in our preclinical research we believe IDX21437 has strong potential to be a key component of a fixed dose all-oral pan-genotypic regimen specifically in combination with samatasvir our NS5A inhibitor. Turning to samatasvir, this program has also shown good progress over the last several months.
We have completed enrollment with 63 patients in Part A of the Phase II 12 week HELIX-1 clinical trial evaluating an all-oral direct acting antiviral or DAA HCV combination regimen, this regimen includes samatasvir and simeprevir a once daily NS3/4A protease inhibitor jointly developed by Janssen and METAVIR and ribavirin and treatment-naïve, non-cirrhotic, genotype 1b or 4 HCV-infected patients, [indiscernible] data for all patients in Part A of the study are anticipated to be available late in the fourth quarter of 2013. Part B of the HELIX-1 clinical trial includes exploratory cohorts which have been added to evaluate the safety in anti-viral activity of a 25 milligram dose of samatasvir and genotype 1b infected patients and a 100 milligram dose of samatasvir and genotype 6 infected patients, Idenix is also planning to initiate a second 12 week Phase II clinical trial in collaboration with Janssen, this trial called HELIX-2 will evaluate the three-DAA combination of samatasvir, simeprevir and TMC647055 a once-daily NS5B non-nucleoside polymerase inhibitor boosted with low dose ritonavir, being developed by Janssen with and without ribavirin.
This trial will include genotype 1 infected patients who are either treatment naïve or previously relapsed after treatment with pegylated interferon and ribavirin. The ongoing HELIX-1 study is building the safety and antiviral efficacy profile for samatasvir as part of a 12 week all-oral treatment regimen and supporting future combination studies including the three-DAA HELIX-2 study as well as the evaluation of a pan-genotypic combination with IDX21437 in 2014. 963 is at this point it's kind of the back up to 437? That's probably not unreasonable given that our intention is to begin dosing patients with 437 next week.
I think with regard to 963, as you recall, we reported earlier in the summer of this year that we had a positive Ames test, a positive TA1535 with 963. We're continuing to evaluate that toc [ph] signal before we put it into the clinic. So as that data becomes available we'll make it available, but at this point we don't have any additional update there.
Can you maybe give us a sense of the timeline for those additional studies? They're ongoing. We are continuing to work on it, but 437 emerged with a very strong profile and in terms of it being a clinical candidate that is now the lead candidate and that's where we're focusing a significant part of our attention. We will continue to look at the preclinical profile of 963 and try to solve what we saw earlier this summer, what we reported on earlier this summer and as I said, when that becomes available I don't have a specific timing on, but when it becomes available we'll have that focus now.
Doug Mayers: This is a very clean molecule. We done significant genotoxicity testing and then so fast we were line up very cleanly against each other in this testing. We had good safety margins as Ron mentioned it has a clean genotype profile and we did extensive cardio attacks with biomarkers, Actos in the monkeys baseline in one month, and basically we seen nothing in the cardiac profile suggest any potential for injury.
It is one of our new generation, you are dealing nucleotide prodrug. So it does have high triphosphate and when we factor that all in, we think we will able to get very good activity and it does significantly lower than that for [indiscernible] currently in the clinic when we testing that over next of few months.