Apellis Provides Update on APL-9 for Severe COVID-19
March 04 2021 - 4:05PM
Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global
biopharmaceutical company and leader in targeted C3
therapies, today announced that the company will not pursue
additional development of APL-9, an investigational targeted C3
therapy designed for acute interventions, for the treatment of
severe COVID-19. The decision followed an interim review of
mortality data from the Phase 1/2 study by an independent data
monitoring committee (DMC), which found no meaningful reduction in
the overall mortality rate in patients treated with APL-9 in
combination with standard of care therapy compared to standard of
care alone. No safety signals were observed by the DMC.
“We initiated the clinical development of APL-9 in patients with
severe COVID-19 because we believed that complement dysregulation
may play a key role in disease mortality. We felt a responsibility
to learn if controlling complement could help save lives during
this devastating pandemic,” said Lukas Scheibler, Ph.D., chief
innovation officer at Apellis. “While the mortality results from
this study were not what we had hoped, we extend our heartfelt
thanks to the patients and their families, healthcare providers,
and investigators who joined us in working to address an urgent
public health need. We remain confident in the potential of
targeting C3 for complement-driven diseases and are committed to
bringing transformative treatments to patients.”
No additional endpoints were analyzed as part of the interim
review by the DMC. Enrollment is complete, and the study reached
the last patient visit. Apellis plans to provide full results in a
scientific forum following completion of the full data
analysis.
About APL-9APL-9 is an investigational drug
designed to control the complement cascade centrally at C3 and may
have the potential to treat a range of diseases caused by excessive
or uncontrolled activation of complement. APL-9 leverages the same
mechanism of action as Apellis’ lead compound, pegcetacoplan
(APL-2), but has a lower molecular weight and shorter half-life.
APL-9 is designed to be intravenously administered for acute
use.About Apellis Apellis Pharmaceuticals,
Inc. is a global biopharmaceutical company that is committed to
leveraging courageous science, creativity, and compassion to
deliver life-changing therapies. Leaders in targeted C3 therapies,
we aim to develop transformative therapies for a broad range of
debilitating diseases that are driven by excessive activation of
the complement cascade, including those within hematology,
ophthalmology, nephrology, and neurology. For more information,
please visit http://apellis.com.
Apellis Forward-Looking
Statement 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 the company’s clinical trials will be
fully enrolled and completed when anticipated; 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 will be indicative of results that will
be generated in future clinical trials;
whether pegcetacoplan will successfully advance through
the clinical trial process on a timely basis, or at all; whether
the results of the company’s clinical trials will warrant
regulatory submissions and whether pegcetacoplan will
receive approval from the FDA or equivalent foreign regulatory
agencies for GA, PNH, CAD, C3G, IC-MPGN, ALS or any other
indication when expected or at all; whether, if Apellis’ products
receive approval, they will be successfully distributed and
marketed; and other factors discussed in the “Risk Factors” section
of Apellis’ Annual Report on Form 10-K filed with the Securities
and Exchange Commission on February 25, 2020 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: Lissa
Pavluk media@apellis.com 617.977.6764
Investor Contact:Argot
Partnersapellis@argotpartners.com+1 212.600.1902
Apellis Pharmaceuticals (NASDAQ:APLS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Apellis Pharmaceuticals (NASDAQ:APLS)
Historical Stock Chart
From Apr 2023 to Apr 2024