As part of the partial clinical hold placed on IDX184, the
FDAhas requested additional cardiac testing of patients in the ongoing phase IIb clinical trial of IDX184. More than 50 patients have been scheduled for echocardiograms, and the Company is on track to submit these data to the FDAin the coming weeks. To date, echocardiograms have been performed on a small number of these patients, and the results are normal.
FDA places clinical hold on Idenix Pharmaceuticals’ hepatitis C drug IDX19368
Last Updated:August 27, 2012 12:25
Idenix Pharmaceuticals' shares fell as much as 12 percent on Monday on news that the FDA placed a clinical hold on its hepatitis C compound IDX19368 due to cardiac-related concerns about Bristol-Myers Squibb's BMS-986094, which belongs to the same nucleotide polymerase inhibitor drug class. The company also said the FDA had requested additional cardiac testing of patients in an ongoing Phase IIb trial of its other hepatitis C treatment, IDX184, as part of a recent partial clinical hold on the compound stemming from the BMS-986094 concerns, and that it expects to submit the data in the coming weeks.
CEO Ron Renaud stated that "based on our discussions with the FDA, we understand the clinical hold [on IDX19368] is a precautionary decision." Idenix confirmed that no patients were exposed to IDX19368 thus far. Last week, Bristol-Myers Squibb reported that it would halt development of its therapy after one patient died and eight others were hospitalised in clinical trials.
Renaud explained that while "both IDX184 and IDX19368 fall into the same broader class of NS5B inhibitors, and share the same active metabolite as BMS-986094,…there are many attributes of our compounds, particularly the prodrug approach, that we believe favourably differentiate the toxicity profiles" from BMS-986094. He added that Bristol-Myers Squibb "agreed to share relevant information on BMS-986094 with us and hope this helps us to resolve this issue quickly."
Commenting on the news, Brean Murray Carret & Co. analyst Brian Skorney remarked, "I don’t think it takes both Idenix drugs off the table, but it does slow them down."
Idenix Drops After FDA Places Hold on Hepatitis C Drug - (Bloomberg)
Idenix Provides Update on IDX19368 Development Program - (GlobeNewswire)
Idenix: FDA Places Hepatitis C Treatment on Clinical Hold - (Morningstar)
Idenix Hep C Fortunes Fade Fast - (TheStreet)
Press Release - Idenix Provides Update on IDX19368 Development Program
IDX19368, for Which Idenix Has Submitted an IND Application, Has Been Placed on Clinical Hold by FDA
"Based on our discussions with the
As part of the partial clinical hold placed on IDX184, the
IDX19368 is an unpartnered liver-targeted nucleotide prodrug of 2'-methyl guanosine and was selected from a prodrug series of approximately 350 compounds. It has shown high triphosphate levels in vivo, with a low potential for drug-drug interactions.
In the third quarter of 2012, Idenix submitted an investigational new drug (IND) application for IDX19368 with plans to initiate clinical trials in the third quarter of 2012. However, these clinical trials will not commence until the
IDX184 is an unpartnered, novel, liver-targeted nucleotide prodrug of 2'-methyl guanosine, which includes Idenix's proprietary liver-targeting technology. This technology enables the delivery of nucleoside monophosphate to the liver, leading to the formation of high levels of nucleoside triphosphate, potentially maximizing drug efficacy and limiting systemic side effects with low, once-daily dosing.
This press release contains "forward-looking statements" for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding the Company's development of drug candidates and its future business performance. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "expect," "plans," "anticipates," "intends," "will," and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the Company's potential pipeline candidates, including any expressed or implied statements regarding the Company's ability to continue clinical development of IDX184 and IDX19368, the efficacy and safety of IDX184 and IDX19368; the likelihood and success of any future clinical trial involving IDX184 and IDX19368 and the successful development of these compounds. Actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including but not limited to the following: there can be no guarantees that the Company will advance any clinical product candidate or other component of its potential pipeline to the clinic, to the regulatory process or to commercialization; management's expectations could be affected by unexpected regulatory actions or delays; uncertainties relating to, or unsuccessful results of, clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates and clinical trials of compounds under development by other companies; changes in the Company's business plan or objectives; competition in general; and the Company's ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management's expectations are described in greater detail under the heading "Risk Factors" in the Company's annual report on Form 10-K for the year ended
All forward-looking statements reflect the Company's estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the Company's views, expectations or beliefs at any date subsequent to the date of this release. While Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the Company's estimates change.
CONTACT: Idenix Pharmaceuticals Contacts:
Kelly Barry(617) 995-9033 (media) Daniella Beckman(617) 224-4471 (investors)
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