Apellis Pharmaceuticals Announces Poster Presentations at the American Society of Hematology Annual Meeting
November 01 2018 - 10:50AM
Apellis Pharmaceuticals Inc. (Nasdaq:APLS), a clinical-stage
biopharmaceutical company focused on the development of novel
therapeutic compounds to treat disease through the inhibition of
the complement system, announced today that two abstracts related
to the company’s hematology program have been accepted for poster
presentations at the 60th American Society of Hematology (ASH)
Annual Meeting and Exposition, to be held in San Diego, California,
from December 1-4, 2018. The abstracts were published today on the
ASH conference website.
One abstract provides updates on PADDOCK, a
Phase 1b open-label, dose-escalation trial designed to assess the
safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD)
and efficacy of multiple doses of APL-2, administered by daily
subcutaneous injection (SC), in patients with paroxysmal nocturnal
hemoglobinuria (PNH). The second abstract provides updates on
PLAUDIT, a Phase 2, open-label trial assessing the safety,
tolerability, efficacy, and PK of multiple subcutaneous (SC) doses
of APL-2 administered daily in patients with autoimmune hemolytic
anemia (AIHA), including warm autoimmune hemolytic anemia (wAIHA)
and cold agglutinin disease (CAD).
Poster Presentation 1: Inhibition of C3
with APL-2 Results in Normalization of Markers of Intravascular and
Extravascular Hemolysis in Patients with Paroxysmal Nocturnal
Hemoglobinuria (PNH)Session Name: 101. Red Cells and
Erythropoiesis, Structure and Function, Metabolism, and Survival,
Excluding Iron: Poster IIDate: Sunday, December 2, 2018Presentation
Time: 6:00 PM - 8:00 PMLocation: San Diego Convention Center, Hall
GH
Poster Presentation 2: Inhibition of C3
with APL-2 Results in Normalization of Markers of Intravascular and
Extravascular Hemolysis in Patients with Autoimmune Hemolytic
Anemia (AIHA)Session Name: 101. Red Cells and
Erythropoiesis, Structure and Function, Metabolism, and Survival,
Excluding Iron: Poster III Date: Monday, December 3, 2018
Presentation Time: 6:00 PM - 8:00 PM Location: San Diego Convention
Center, Hall GH
In accordance with ASH policies, abstracts
submitted to the ASH Annual Meeting are embargoed from the time of
submission. To be eligible for presentation at the ASH Annual
Meeting, information contained in the abstract, as well as
additional data and information to be presented at the Annual
Meeting, may not be made public before the abstract has been
presented in connection with the ASH Annual Meeting.
About APL-2 APL-2 is
designed to inhibit the complement cascade centrally at C3 and may
have the potential to treat a wide range of complement-mediated
diseases more effectively than is possible with partial inhibitors
of complement. APL-2 is a synthetic cyclic peptide conjugated to a
polyethylene glycol (PEG) polymer that binds specifically to C3 and
C3b, effectively blocking all three pathways of complement
activation (classical, lectin, and alternative).
Clinical trials Apellis is
currently evaluating APL-2 in two Phase 1b trials (PHAROAH and
PADDOCK) for systemic administration in paroxysmal nocturnal
hemoglobinuria. Previously reported interim data from these trials
showed improvements in lactate dehydrogenase and hemoglobin levels
in patients who are suboptimal responders to eculizumab and
untreated patients, respectively. Apellis is also testing
APL-2 for systemic administration in a Phase 2 clinical trial in
autoimmune hemolytic anemia (AIHA) and a Phase 2 clinical trial in
complement dependent nephropathies, as well as a Phase 3 trial for
patients with PNH.
About Apellis Apellis
Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical
company focused on the development of novel therapeutic compounds
for the treatment of a broad range of life-threatening or
debilitating autoimmune diseases based upon complement
immunotherapy through the inhibition of the complement system at
the level of C3. Apellis is the first company to advance chronic
therapy with a C3 inhibitor into clinical trials. For additional
information about Apellis and APL-2, please
visit http://www.apellis.com. For additional information
regarding our clinical trials,
visit www.apellis.com/clinical-trials.html.
Forward-Looking
Statements Statements in this press release
about future expectations, plans and prospects, as well as any
other statements regarding matters that are not historical facts,
may constitute “forward-looking statements” within the meaning of
The Private Securities Litigation Reform Act of 1995. These
statements include, but are not limited to, statements relating to
the implications of preliminary clinical data. The words
“anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,”
“intend,” “may,” “plan,” “potential,” “predict,” “project,”
“should,” “target,” “will,” “would” and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Actual
results may differ materially from those indicated by such
forward-looking statements as a result of various important
factors, including: whether preliminary or interim results from a
clinical trial will be predictive of the final results of the
trial; whether results obtained in preclinical studies and clinical
trials such as the results reported in this release will be
indicative of results that will be generated in future clinical
trials; whether APL-2 will successfully advance through the
clinical trial process on a timely basis, or at all; whether the
results of such clinical trials will warrant regulatory submissions
and whether APL-2 will receive approval from the United States
Food and Drug Administration or equivalent foreign regulatory
agencies for GA, PNH or any other indication; whether, if Apellis’
products receive approval, they will be successfully distributed
and marketed; and other factors discussed in the “Risk Factors”
section of Apellis’ Quarterly Report on Form 10-Q filed with
the Securities and Exchange Commission on July 31,
2018 and the risks described in other filings that Apellis may
make with the Securities and Exchange Commission. Any
forward-looking statements contained in this press release speak
only as of the date hereof, and Apellis specifically disclaims any
obligation to update any forward-looking statement, whether as a
result of new information, future events or otherwise.
Media Contact: Tully
Nicholastnicholas@denterlein.com 617.482.0042 (office)
860.490.0218 (mobile)
Investor Contact: Alex
Kane akane@w2ogroup.com 212.301.7218 (office) 929.400.2691
(mobile)
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