Idenix Suspends Testing of HCV Polymerase Inhibitor Valopicitabine (NM283)
On
July 13, Idenix Pharmaceuticals announced the suspension of clinical trials of
its experimental hepatitis C virus (HCV) polymerase inhibitor, valopicitabine
(formerly NM283), after the U.S. Food and Drug Administration indicated that
the drug's risk of gastrointestinal (GI) side effects appeared to outweigh its
benefits.
However,
the drug produced a high rate of side effects such as nausea, vomiting, and diarrhea
at the doses initially tested. For this reason, researchers reduced the dose from
800 to 200 mg. The lower dose improved the drug's adverse events profile, but
it was still associated
with considerable GI toxicity.
Below
is the text of an Idenix press release announcing the latest developments and
its drug development plans:
Valopicitabine
Development Program Placed on Clinical Hold in the United States
Cambrige,
Mass., July 13 -- PRNewswire-FirstCall -- Idenix Pharmaceuticals, Inc. (Nasdaq:
IDIX) today announced that after discussions with the United States Food and Drug
Administration (FDA) the development program of valopicitabine (NM283) for the
treatment of hepatitis C has been placed on clinical hold in the United States
based on the overall risk/benefit profile observed to date in clinical testing.
"We
are disappointed with the FDA's perspective on the program and are working with
Novartis to evaluate our options for valopicitabine," said Jean- Pierre Sommadossi,
PhD, chairman and chief executive officer of Idenix. "We remain committed
to building a leading antiviral franchise and will continue to focus on ensuring
a successful launch of Tyzeka/Sebivo [telbivudine, an approval therapy for hepatitis
B] and on advancing our pipeline. We have a novel non-nucleoside reverse transcriptase
inhibitor being evaluated in phase I clinical testing for the treatment of HIV.
Additionally, we have a comprehensive HCV discovery effort, which includes a second-generation
nucleoside polymerase inhibitor that is being evaluated in IND-enabling preclinical
testing and novel HCV non-nucleoside polymerase inhibitor and HCV protease inhibitor
programs."
As of June 30, 2007, Idenix had approximately $160 million
of cash, cash equivalents and marketable securities.
"Over the next
few weeks, we will be taking a critical look at our expenses with the goal of
investing in programs that we believe will create shareholder value," said
Ronald Renaud, chief financial officer of Idenix. "Our balance sheet is strong
and we believe that we have enough cash to fund early clinical development of
the pipeline."
