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The FDA places GSK2248761 ('761', formerly IDX899) a NNRTI on clinical hold
 
 
  ViiV has said the reason for the FDA development hold on 'GSK-761', a drug developed by Idenix and licensed to ViiV and currently in Phase 2B trials, involved four reports of seizures as part of a clinical trial involving treatment-experienced patients. So the drug has been put on 'clinical hold' while the company gathers further information in trying to decide the future course of action and for FDA review.
 
Letters have been sent to the study investigators who are to contact their patients and inform them of the risk of seizures and bring them in as soon as possible to change their medication from GKS761 and provide followup care. ViiV said the overall development program of GSK-761 has not been halted. This is the most recent halt on a drug developed by Idenix, an HCV drug program was also put on hold last year.
 
"GSK2248761, a nonnucleoside (NNRTI) in phase 2 development at GlaxoSmithKline, selected no mutations in reverse transcriptase in 36 antiretroviral-naive people who took the drug as monotherapy for 7 days [1]. Viral load reductions over the 7 days ranged from 0.97 to 1.87 log with the 5 doses studied.......Previous in vitro data indicate a higher barrier to resistance and a good overall resistance profile.....IDX899 remained active against EFVR (efavirenz-resistance) virus pools containing up to 4 mutations. Among the 4 tested drugs, IDX899 showed the best activity against both TMC125R and EFVR virus pools, and the best overall activity against all 24 NNRTI-selected virus pools and no patients discontinued."
 
GSK New NNRTI Selects No Resistance Mutations in 7 Days of Monotherapy
GSK veteran chief virologist Marty St. Clair presented resistance data from two dose-ranging monotherapy studies of 761. Both were double-blind, ... www.natap.org/2010/ICAAC/ICAAC_30.htm
 
New GSK761 NNRTI
New GSK761 NNRTI. "Previous in vitro data indicate a higher barrier to resistance and a good overall ... GSK Acquires New HIV NNRTI IDX899 From Idenix ...www.natap.org/2010/ICAAC/ICAAC_24.htm
 
FROM THIS MORNING:
Idenix was informed by ViiV Healthcare Company (ViiV), an affiliate of GlaxoSmithKline (GSK), that '761, a non-nucleoside reverse transcriptase inhibitor drug candidate for the treatment of HIV/AIDS licensed by Idenix to GSK, was placed on clinical hold by the FDA. ViiV has full responsibility for the development of '761, including any regulatory interactions.
 
Idenix Pharmaceuticals Provides Updates on Three Clinical Development Programs
 
* The FDA removes the full clinical hold on IDX184, and places it on partial clinical hold; Idenix anticipates initiating a Phase IIb study in the second half of 2011
 
* The company discontinues clinical development of IDX320
 
* The FDA places GSK2248761 ('761, formerly IDX899) on clinical hold
 
CAMBRIDGE, Mass., Feb. 9, 2011 /PRNewswire/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced updates to three clinical development programs.
 
IDX184, a liver-targeted HCV nucleotide prodrug
 
The U.S. Food and Drug Administration (FDA) has verbally informed Idenix that the full clinical hold for IDX184 has been removed. The program has been placed on partial clinical hold, and Idenix anticipates initiating a Phase IIb12-week trial of IDX184 in combination with pegylated interferon and ribavirin in the second half of 2011.
 
The clinical hold was issued in September 2010 as a result of three cases of elevated liver function tests observed during a drug-drug interaction study of the combination of IDX184 and IDX320, an HCV protease inhibitor, in healthy volunteers. Idenix reviewed available data and conducted additional preclinical studies. With the help of independent experts and an external safety committee, the company concluded that the observed toxicity was likely caused by IDX320. Idenix submitted a response to the clinical hold to the FDA in January 2011.
 
IDX320, an HCV protease inhibitor
 
Based on Idenix's conclusion that the observed toxicity in the drug-drug interaction study was likely caused by IDX320, the company has discontinued the development of IDX320. Next generation protease inhibitors that may potentially avoid the observed hepatotoxicity are in preclinical development at Idenix.
 
GSK2248761 ('761, formerly IDX899), an HIV non-nucleoside reverse transcriptase inhibitor
 
Idenix was informed by ViiV Healthcare Company (ViiV), an affiliate of GlaxoSmithKline (GSK), that '761, a non-nucleoside reverse transcriptase inhibitor drug candidate for the treatment of HIV/AIDS licensed by Idenix to GSK, was placed on clinical hold by the FDA. ViiV has full responsibility for the development of '761, including any regulatory interactions.
 
Under the collaboration arrangement between Idenix and GSK, Idenix has received $60.5 million in license fees, equity investment and milestone payments to date and is eligible to receive up to $390.0 million in additional milestone payments as well as double-digit tiered royalties on worldwide product sales.
 
 
 
 
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