ANA598 Receives Fast Track Designation From the FDA

Hi Bill and all friends,

Help me to check following today news. And kindly give comments for this article:

http://biz.yahoo.com/prnews/081201/la49254.html?.v=1

Following is detail:ANA598 Receives Fast Track Designation From the FDA for the Treatment of Chronic Hepatitis C Infection

Monday, December 01, 2008 6:38 PM



SAN DIEGO, Dec. 1 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) today announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation to ANA598 for the treatment of chronic hepatitis C virus (HCV) infection. ANA598 is Anadys' investigational hepatitis C non-nucleoside polymerase inhibitor. Anadys is currently enrolling patients in a Phase Ib study evaluating ANA598 for the treatment of patients chronically infected with HCV.


Under the FDA Modernization Act of 1997, fast track designation is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions. Compounds selected must demonstrate the potential to address an unmet medical need for such a condition. Mechanisms intended to facilitate development include opportunities for frequent dialogue with FDA reviewers and for timely review of submitted protocols. However, the designation does not guarantee approval or expedited approval of any application for the product. The granting of fast track status for the ANA598 development program is consistent with the need for HCV treatments with novel mechanisms of action, oral administration, non-overlapping resistance profiles and improved safety and efficacy over the existing standard of care for both treatment-naive and treatment-experienced patients.


'The FDA's fast track designation for ANA598 acknowledges the need for new HCV therapies to improve treatment outcomes,' commented James Freddo, M.D., Anadys' Senior Vice President, Drug Development and Chief Medical Officer. 'We anticipate continuing to work closely with the FDA on the development and regulatory review of ANA598, one of the few non-nucleoside polymerase inhibitors in clinical development for the treatment of HCV. We continue to believe this class of antivirals holds great promise as a component of future HCV treatment regimens.'


About ANA598


Anadys recently initiated patient dosing in a Phase Ib study of ANA598 in HCV patients. In the Phase Ib study, naive genotype 1a and 1b patients are to receive ANA598 over three days at doses of 200 mg bid (twice-a-day), 400 mg bid or 800 mg bid. Ten patients will be enrolled at each dose level, eight receiving active drug and two receiving placebo.


In a Phase I study in healthy volunteers, ANA598 was administered as capsules at single oral doses of 400 mg, 800 mg, 1400 mg, 2000 mg (fed and fasted) and 3000 mg. In addition, a separate cohort received two 800 mg doses 12 hours apart. ANA598 was well tolerated at all doses and there were no serious adverse events or withdrawals from the study, although definitive conclusions regarding product safety and tolerability cannot be made until the results of future clinical trials of longer duration in more patients are known.

[aungkyawsan]

Hi All,
Any comment for above ??? Thank you guys..

[copyman]

my only comment would be it is another new drug added to the many that are in trials already. The two leaders Boceprevir & Telaprevir are way ahead of these other comapnies.  Bottom line is money. The comapny that find the "cure" will become a multi BILLION dollar company overnight upon FDA approval.

[foofighter]

You are finding some good stuff out there! All of this is good news, especially for those that will be able to wait a couple more years before treating.

A drug has to get to at least Phase 2 before people can get too excited and even then, they can fall out.  I screened for a Phase 2 that was stopped because of toxicity and I think that R1626 is in a holding pattern at Phase 2 as well.

The big hope is that a few years down the road they will add the protease and polymerase to one big cocktail that will cure people once and for all. Or who knows, maybe something completely different.

I hope that your wife will be one that can safely wait and get that cure with a shorter, more tolerable treatment.

[aungkyawsan]

Thank you guys for enlightening me... I think I am too much excited on those news.. for my wife..
Thanks you guys...

[pjhep80]

and some make it all the way to phase iii and then fail to meet the specs... like the virimadine trial i was on...

i have heard the PI telepriv and bocepriv trials are due to end may 2010, i wonder how long after that it would be fda approved if all the results are good...??  not too much i hope.... its looking like i might not get in on the trials so im one of those watching and waiting also

[copyman]

there is talk of 2011 but who knows with the FDA

[can-do-man]

The phase 3 trials for both of these drugs (relapsers and nonresponders) should be finished about this time next year, then theres the 6 month follow up. I think copyman has hit it just right.

[FlGuy]

Although all I've read about this is in this thread, it's interesting that there's no mention of Peg or Riba.

[Bill1954]

Good catch FL; and no mention of the other meds here, either:

http://clinicaltrials.gov/ct2/show/NCT00782353?term=hcv&intr=ANA598&rank=1

This is only a small, phase 1 trial; monotherepy only. Maybe due to it’s phase 1 status?
It’s interesting to see that someone in the FDA decided to push this one through fast too; I wonder what parameters are involved in the fast-track designation?

Aung- All of the other experimental drugs currently in development require the additional use of interferon and ribavirin to prevent the development of viral mutation.

[aungkyawsan]

Thank you all..........