Chicago, Illinois – April 30th, 2018 – Exicure, Inc., the pioneer
in gene regulatory and immunotherapeutic drugs utilizing three-dimensional
spherical nucleic acid (SNA™)
constructs, today announced results from the Phase 1b clinical trial of
its compound, AST-005, designed to reduce the expression of tumor necrosis
factor (TNF). In 2016, Exicure entered
into a research collaboration, option and license agreement with Purdue Pharma
L.P. As part of Exicure's collaboration
with Purdue Pharma, a Phase 1b clinical trial was conducted in Germany to
evaluate the effect of AST-005 gel in patients with chronic plaque psoriasis. The
trial evaluated the safety, tolerability, and plaque thickness following
topical application of different strengths of AST-005 formulated as a topical
gel.
The trial
demonstrated that AST-005 is safe and tolerable in patients at higher doses
than were previously studied. Seventy-five areas of skin were treated with
AST-005 gel across twenty-five patients. One mild and one moderate adverse event
in a single patient was reported in a placebo treated area. No serious adverse events
were observed in any patient. As designed, however, the study did not result in
a statistically significant decrease in echo lucent band thickness, one of the
key indicators of efficacy in patients with psoriasis.
Purdue Pharma has notified Exicure it has declined to exercise its
option to develop AST-005 at this time, but that it also intends to retain
rights relating to the TNF target, and Purdue reserves its right to continue joint
development, with Exicure, of new anti-TNF drug candidates and to retain its exclusivity
and other rights to AST-005.
About Exicure, Inc.
Exicure,
Inc. is a clinical stage biotechnology company developing a new class of
immunomodulatory and gene regulating drugs against validated targets. Exicure's
proprietary 3-dimensional, spherical nucleic acid (SNA™) architecture unlocks
the potential of therapeutic oligonucleotides in a wide range of cells and
tissues. Exicure's lead programs address inflammatory diseases, genetic
disorders and oncology. Exicure is based outside of Chicago, Illinois. www.exicuretx.com
Forward Looking Statements
This press
release contains forward-looking statements (including within the meaning of
Section 21E of the United States Securities Exchange Act of 1934, as amended,
and Section 27A of the United States Securities Act of 1933, as amended) concerning
the Company, the collaboration with Purdue, potential joint development, and
other matters. Forward-looking statements generally include statements that are
predictive in nature and depend upon or refer to future events or conditions,
and include words such as "may," "will,"
"should," "would," "expect," "plan,"
"believe," "intend," "look forward," and other
similar expressions among others. Statements that are not historical facts are
forward-looking statements. Forward-looking statements are based on current
beliefs and assumptions that are subject to risks and uncertainties and are not
guarantees of future performance. Actual results could differ materially from
those contained in any forward-looking statement as a result of various
factors, including, without limitation: unexpected costs, charges or expenses;
that Exicure's programs do not advance into the clinic or result in approved
products on a timely or cost-effective basis or at all; regulatory
developments; and the ability of Exicure to protect its intellectual property
rights. Exicure's pipeline programs are in early stages of research and
development, and the process by which pre-clinical or clinical therapeutic
candidates could potentially lead to an approved therapeutic is long and
subject to significant risks and uncertainties. Risks facing the Company and
its programs are set forth in the Company's filings with the SEC. Except as
required by applicable law, the Company undertakes no obligation to revise or
update any forward-looking statement, or to make any other forward-looking
statements, whether as a result of new information, future events or otherwise.
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Media Contact
Karen Sharma
ksharma@macbiocom.com
781-235-3060