- Dosing Initiated in Phase 1 Study to Evaluate
the Safety, Tolerability and Antiviral Activity of ACH-3422, NS5B
Uridine-Analog Nucleotide Prodrug -
- Initiated Phase 2 Study Evaluating ACH-3102,
Second-Generation NS5A Inhibitor, With Sofosbuvir for 8 Weeks of
Treatment or Less in Genotype 1 HCV Treatment-Naïve Patients -
Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN)
today announced that is has begun dosing study participants with
ACH-3422, Achillion's proprietary uridine-analog nucleotide
inhibitor, in a Phase 1 clinical trial. ACH-3422 is being developed
for use in combination regimens to treat chronic hepatitis C viral
infection (HCV). Achillion also announced the initiation of dosing
in a Phase 2 pilot study evaluating ACH-3102, Achillion's
second-generation NS5A inhibitor, in combination with sofosbuvir
for eight and potentially six weeks of treatment for patients with
chronic genotype 1 treatment-naïve HCV.
"We believe that a nucleotide inhibitor and NS5A combination is
the cornerstone for pan-genotypic commercially competitive
regimens, having demonstrated high response rates and short
duration of therapy. With the addition of a third direct-acting
antiviral such as a protease inhibitor, we believe we can
potentially shorten therapy to less than eight weeks," commented
Milind Deshpande, Ph.D., President and Chief Executive Officer of
Achillion.
ACH-3422: Phase 1 Study in Healthy Subjects and
Proof-of-Concept in HCV-infected Patients
Achillion is conducting a Phase 1 randomized, double-blind,
placebo-controlled trial to investigate the safety, tolerability,
pharmacokinetics and antiviral activity of ACH-3422. Cohorts of
healthy subjects will be enrolled at each dose level to receive a
single-ascending dose followed by multiple-ascending doses for 14
days. At each dose level, patients with treatment-naïve genotype 1
HCV will receive 7 days of ACH-3422 to assess safety and antiviral
activity. The starting dose in this trial will be 50 mg of ACH-3422
with the study expected to enroll a total of approximately 100
healthy volunteers and HCV-infected patients. Preliminary results,
including safety and antiviral activity, are expected to be
reported during the fall of 2014. This study is being conducted
outside of the United States.
Dr. Deshpande further commented, "ACH-3422 has been rigorously
evaluated in preclinical studies, which we believe support clinical
advancement of ACH-3422. Preclinical data indicate that ACH-3422
has potency comparable to sofosbuvir against GT1 HCV, and has
potency up to 7-fold higher against GT3 HCV. As we work to complete
the healthy subject and HCV-infected patient cohorts in this
ACH-3422 study, we are simultaneously exploring the characteristics
of ACH-3102 in combination with sofosbuvir in a pilot trial that
will evaluate an eight week or shorter treatment regimen and that
we expect will be highly informative for initiation of combination
studies of ACH-3422 and ACH-3102. We are eager to begin reporting
preliminary results from these two programs starting late this
summer and through the remainder of this year."
ACH-3102: Phase 2 Pilot Study Evaluating 8-week
treatment in combination with sofosbuvir for genotype 1
treatment-naïve HCV
Achillion is conducting a Phase 2, open-label, randomized,
partial-crossover study to evaluate the efficacy, safety, and
tolerability of eight weeks or six weeks of ACH-3102 and sofosbuvir
in treatment-naïve genotype 1 HCV-infected patients. The primary
objective for the study is determination of sustained viral
response 12 weeks (SVR12) after the completion of therapy. Twelve
patients will be enrolled and receive eight weeks of treatment
consisting of 50 mg of ACH-3102 and 400 mg of sofosbuvir
administered once daily. The trial protocol also allows for the
enrollment of additional HCV-infected patients who may be eligible
to receive six weeks of treatment consisting of 50 mg of ACH-3102
and 400 mg of sofosbuvir administered once daily. Preliminary
results from the eight-week treatment duration cohort are
anticipated during the summer of 2014. This study is being
conducted outside the United States.
David Apelian, M.D., Ph.D., Executive Vice President and Chief
Medical Officer commented, "Our focus is to safely and
expeditiously advance our all-oral regimens for the treatment of
HCV. The initiation of our first clinical study with our nucleotide
inhibitor ACH-3422 is an important milestone for the Achillion
portfolio. We expect that evaluation of our NS5A inhibitor ACH-3102
in combination with sofosbuvir will provide significant insights
for our ultimate use of ACH-3422 and ACH-3102 in combination.
Furthermore, we believe the breadth of our portfolio, which
includes our protease inhibitors, could enable us to potentially
develop commercially-competitive regimens that can be safe,
effective, ribavirin-free and that can be used for eight weeks or
less to potentially cure HCV."
About HCV
The hepatitis C virus is the most common cause of viral
hepatitis, which is an inflammation of the liver. It is currently
estimated that more than 150 million people are infected with HCV
worldwide including more than 5 million people in the United
States. Three-fourths of the HCV patient population is undiagnosed;
it is a silent epidemic and a major global health threat. Chronic
hepatitis, if left untreated, can lead to permanent liver damage
that can result in the development of liver cancer, liver failure
or death. Few therapeutic options currently exist for the treatment
of HCV infection.
About Achillion Pharmaceuticals
Achillion is an innovative pharmaceutical company dedicated to
bringing important new treatments to patients with infectious
disease. Achillion's discovery, clinical development, and
commercial teams have advanced multiple novel product candidates
with proven mechanisms of action into studies and toward the
market. Achillion is focused on solutions for the most challenging
problems in infectious disease including HCV and resistant
bacterial infections. For more information on Achillion
Pharmaceuticals, please visit www.achillion.com or call
1-203-624-7000.
Cautionary Note Regarding Forward-Looking
Statements
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other important
factors that could cause actual results to differ materially from
those indicated by such forward-looking statements, including
statements with respect to: the Company's expectations that the
phase I study of ACH-3422 inform the potential initiation of
combination studies of ACH-3422 and ACH-3102; the Company's
expectations that it may report preliminary results from its Phase
1 program during the fall of 2014 and Phase 2 pilot study beginning
in late summer 2014; the Company's goal to safely and expeditiously
advance its all-oral regimens for the treatment of HCV and its
expectation that the breadth of its portfolio could enable it to
potentially develop commercially-competitive regimens that can be
safe, effective, ribavirin-free and that can be used for eight
weeks or less to potentially cure HCV. Achillion may use words
such as "expect," "anticipate," "project," "intend," "plan," "aim,"
"believe," "seek," " estimate," "can," "focus," "will," and "may"
and similar expressions to identify such forward-looking
statements. Among the important factors that could cause actual
results to differ materially from those indicated by such
forward-looking statements are risks relating to, among other
things Achillion's ability to: demonstrate in any current and
future clinical trials the requisite safety, efficacy and
combinability of its drug candidates; advance the preclinical and
clinical development of its drug candidates, including ACH-3422,
ACH-3102 and its protease inhibitors, under the timelines it
projects in current and future clinical trials; satisfactorily
respond to the clinical hold placed on sovaprevir by the FDA;
obtain and maintain necessary regulatory approvals; obtain and
maintain patent protection for its drug candidates and the freedom
to operate under third party intellectual property; establish
commercial manufacturing arrangements; identify, enter into and
maintain collaboration agreements with appropriate third-parties;
compete successfully with other companies that are seeking to
develop improved therapies for the treatment of HCV; manage
expenses; manage litigation; raise the substantial additional
capital needed to achieve its business objectives; and successfully
execute on its business strategies. These and other risks are
described in the reports filed by Achillion with the U.S.
Securities and Exchange Commission, including its Annual Report on
Form 10-K for the year ended December 31, 2013, and its subsequent
SEC filings.
In addition, any forward-looking statement in this press release
represents Achillion's views only as of the date of this press
release and should not be relied upon as representing its views as
of any subsequent date. Achillion disclaims any duty to update any
forward-looking statement, except as required by applicable
law.
CONTACT: Company Contact:
Glenn Schulman
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
gschulman@achillion.com
Media:
Emily Johnson
Ogilvy PR
Tel. (212)880-5316
emily.johnson@ogilvy.com
Investors:
Mary Kay Fenton
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
mfenton@achillion.com
Investors:
Tricia Truehart
The Trout Group, LLC
Tel. (646) 378-2953
ttruehart@troutgroup.com
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