CORRECTION - Achillion Pharmaceuticals, Inc.
December 20 2017 - 12:12PM
In the news release issued earlier today by Achillion
Pharmaceuticals, Inc. (Nasdaq:ACHN), please be advised
the headline should read "Achillion Initiates Phase I
First-In-Human Study of ACH-5228, a Next-Generation Oral Small
Molecule Inhibitor of Complement Factor D." Complete corrected text
follows.
Achillion Initiates Phase I First-In-Human Study of
ACH-5228, a Next-Generation Oral Small Molecule Inhibitor of
Complement Factor D
Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN),
a pharmaceutical company focused on advancing small molecule
inhibitors of factor D in the complement alternative pathway, today
announced that the Company has begun dosing subjects in a
first-in-human phase 1 trial of ACH-5228, a next-generation, oral
small-molecule factor D inhibitor.
“During 2017, we reported interim data from our
on-going phase 2 clinical trials, in PNH and in C3G, which
demonstrated that factor D inhibition represents a truly novel,
first-in-class approach to potentially treating these devastating
diseases. As we continue to execute on our global clinical
development strategy with ACH-4471, our next-generation compounds,
including ACH-5228, represent strategic optionality as we look to
expand the breadth of diseases that could potentially be treated
via AP inhibition,” commented Milind Deshpande, Ph.D., President
and Chief Executive Officer of Achillion.
ACH-5228: Phase 1 Healthy Volunteer
Development Program
This initial phase 1 trial is a randomized,
placebo-controlled, single-ascending dose study of ACH-5228
administered to healthy volunteers. Approximately 28 subjects are
expected to be enrolled. The primary endpoint for the trial is
evaluation of safety and tolerability. Secondary endpoints include
assessments of PK, PD, and evaluation of alternative pathway
inhibition in ex vivo laboratory assessments of blood samples from
subjects in order to establish a PK/PD relationship for ACH-5228.
The Company expects to report interim clinical data from this study
during the second half of 2018. (ANZCTR UTN: U1111-1203-1371)
About the Achillion Complement Factor D
Platform
Achillion has leveraged its internal discovery
capabilities and a novel complement-related platform to develop
small molecule drug candidates that are oral inhibitors of
complement factor D. Factor D is an essential serine protease
involved in the complement pathway, a part of the innate immune
system. Achillion's complement platform is focused on seeking to
advance small molecule compounds that inhibit factor D and can
potentially be used in the treatment of immune-related diseases in
which complement alternative pathway plays a critical role.
Potential indications being evaluated for these compounds include
paroxysmal nocturnal hemoglobinuria (PNH), C3 glomerulopathy (C3G),
immune complex-mediated membranoproliferative glomerulonephritis
(IC-MPGN), and geographic atrophy (GA).
About Achillion
Pharmaceuticals
Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN) is
a science-driven, patient-focused company seeking to leverage its
strengths across the continuum from discovery to commercialization
in its goal of providing better treatments for people with serious
diseases. The company employs a highly-disciplined discovery and
development approach that has allowed it to build a platform of
potent and specific complement inhibitors. Achillion is rapidly
advancing its efforts to become a fully-integrated pharmaceutical
company with a goal of bringing life-saving medicines to patients
with rare diseases. More information is available at
http://www.achillion.com.
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.
Achillion may use words such as “expect,” “anticipate,” “project,”
“target,” “intend,” “plan,” “aim,” “believe,” “seek,” “estimate,”
“can,” “could” “focus,” “will,” “look forward,” “goal,” “may,”
“potential,” and similar expressions to identify such
forward-looking statements. These forward-looking statements also
include statements about: the Phase I clinical trial for ACH-5228,
Achillion’s next generation Factor D inhibitor, the timing of
reporting interim results from the Phase I study of ACH 5228 the
potential benefits of, and potential indications for, Achillion’s
compounds that inhibit factor D, including ACH-4471 and ACH-5228;
and statements concerning Achillion’s strategic goals, efforts,
plans, and prospects. 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 complement factor D inhibitors under
the timelines it projects in current and future preclinical studies
and clinical trials; obtain and maintain patent protection for its
drug candidates and the freedom to operate under third party
intellectual property; obtain and maintain necessary regulatory
approvals; establish commercial manufacturing arrangements;
identify, enter into and maintain collaboration and other
commercial agreements with third-parties; compete successfully in
the markets in which it seeks to develop and commercialize its
product candidates and future products; 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 Quarterly Report on Form 10-Q for the
fiscal quarter ended September 30, 2017, and any other SEC filings
that Achillion makes from time to time.
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.
Investors & Media:
Glenn Schulman, PharmD, MPH
Executive Director, Investor Relations
Achillion Pharmaceuticals, Inc.
Tel. (203) 752-5510
gschulman@achillion.com
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