Achillion Announces Acceptance of Late Breaking Abstract for ACH-4471 at the 21st Congress of the European Hematology Associa...
May 19 2016 - 6:05AM
- Interim results, including safety,
pharmacokinetics and pharmacodynamics, to be presented from ongoing
phase 1 single-ascending dose trial with ACH-4471 in healthy
volunteers -
Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN)
today announced the upcoming presentation of an e-poster
summarizing a late breaking abstract accepted for the 21st Congress
of the European Hematology Association (EHA). The e-poster
presentation will report interim results from the ongoing phase 1
single-ascending dose healthy volunteer study being led by Roderick
B. Ellis-Pegler and Christian Schwabe of Auckland Clinical Studies
Ltd, Aukland, New Zealand and a group of researchers from
Achillion. The study, initiated in February 2016, aims to assess
the safety and tolerability of single-ascending oral doses of
ACH-4471 and evaluation of its pharmacokinetic (PK) and
pharmacodynamic (PD) profile and PK/PD relationship as measured by
alternative pathway (AP) activity ex vivo in hemolysis and Wieslab
assays. As described in the abstract, oral dosing of ACH-4471
resulted in rapid, nearly complete and sustained inhibition of
complement alternative pathway activity. ACH-4471 was well
tolerated at the single dose levels examined to date with no
drug-related serious adverse events, treatment emergent adverse
events (TEAE) leading to study discontinuation, or study
drug-related grade 3/4 TEAEs reported.
The congress is being held June 9 – 12, 2016 in
Copenhagen, Denmark. Abstracts can be accessed on the EHA website
at https://www.ehaweb.org and a reprint of the poster
will be available following its presentation under the resources
section of the Achillion website at http://www.achillion.com.
EHA E-Poster Information:
Abstract:
EHA-4145Title: An Orally Administered Small
Molecule Factor D Inhibitor (ACH-4471) For Treatment of PNH and
Complement Diseases: Preliminary Phase I Results in Healthy
VolunteersSession Name: 12. Bone marrow failure
syndromes incl. PNH - Clinical Display Date/Time:
Friday, June 10, 09:30 CET to Saturday, June 11, 19:00 CET
About the Achillion Complement Factor D
Platform
Achillion has leveraged its internal discovery
capabilities and a novel complement-related platform to develop
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 plays a critical
role. Potential indications being evaluated for these compounds
include paroxysmal nocturnal hemoglobinuria (PNH), C3
Glomerulopathy (C3G), dry age-related macular degeneration (dry
AMD), and chronic obstructive pulmonary disease (COPD). Achillion
anticipates that its platform could play a role in addressing the
needs of all PNH patients, including patients who have suboptimal
response to, or fail to respond to, the currently available
treatments, as well as for patients suffering from other
alternative pathway complement-mediated diseases. Achillion
nominated ACH-4471 for clinical development in December 2015, and
initiated clinical development in February 2016.
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 pursue best-in-class
oral antiviral therapy for chronic hepatitis C (HCV) and 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,”
“intend,” “plan,” “aim,” “believe,” “seek,” “ estimate,” “can,”
“focus,” “will,” “look forward,” “goal,” and “may” and similar
expressions to identify such forward-looking statements. These
forward-looking statements also include statements about: the
potential disease indications for the Company’s complement
platform, and its belief that its platform could play a role in
addressing the needs of specified types of patients; the Company’s
plans and strategies; and its clinical development of ACH-4471.
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: replicate in later clinical studies any favorable
findings in preclinical or early-stage healthy volunteers studies
of ACH-4471; 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;
demonstrate in any current and future clinical trials the requisite
safety, efficacy and combinability of its drug candidates; obtain
and maintain necessary regulatory approvals; establish commercial
manufacturing arrangements; identify, enter into and maintain
collaboration 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 March 31, 2016, 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.
Investors:
Glenn Schulman
Senior Director, Investor Relations
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
gschulman@achillion.com
Media:
Liz Power
Senior Director, Public Relations
Achillion Pharmaceuticals, Inc.
Tel: (203) 752-5509
lpower@achillion.com
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