Omeros Corporation Provides Update on Interim Analysis of ARTEMIS-IGAN Phase 3 Trial of Narsoplimab in IgA Nephropathy
16 Ottobre 2023 - 1:30PM
Business Wire
- The ARTEMIS-IGAN trial did not reach statistical significance
on the primary endpoint of reduction in proteinuria from baseline
compared to placebo
- Proteinuria reduction in the placebo group was substantially
greater than reported in other IgA nephropathy clinical trials
- Webcast conference call planned for 8:30 a.m. ET today
Omeros Corporation (Nasdaq: OMER), a clinical-stage
biopharmaceutical company committed to discovering, developing and
commercializing small-molecule and protein therapeutics for
large-market and orphan indications targeting immunologic disorders
including complement-mediated diseases, cancers, and addictive and
compulsive disorders, today provided an update regarding the
interim analysis outcome in ARTEMIS-IGAN, the Company’s Phase 3
trial evaluating narsoplimab for the treatment of immunoglobulin A
(IgA) nephropathy.
The primary endpoint is reduction in proteinuria assessed by
24-hour urine protein excretion (UPE) at 36 weeks compared to
placebo in the intent-to-treat population of 180 IgA nephropathy
patients with high baseline proteinuria (24-hour UPE > 2 g/day).
Topline results show that narsoplimab did not achieve statistically
significant improvement over placebo. The UPE reduction in the
placebo group was markedly greater than that reported in trials of
other agents in IgA nephropathy. Based on the absence of
statistical significance and as previously agreed with FDA, Omeros
will not submit an application for approval of narsoplimab in this
indication and will discontinue the ARTEMIS-IGAN clinical
trial.
“We want to thank all the patients and investigators who
participated in the trial,” said Gregory A. Demopulos, M.D,
chairman and chief executive officer of Omeros. “We will conduct
more detailed analyses of the data to understand better the
outsized placebo effect and the overall trial results and to try to
identify useful biomarkers. The funds earmarked for
commercialization in IgAN and continuation of the ARTEMIS-IGAN
trial will be redirected to our other later-stage programs,
including our ongoing Phase 2 and upcoming Phase 3 programs for our
alternative pathway inhibitor OMS906. In addition, our near-term
focus remains the planned resubmission of our biologics license
application for narsoplimab in hematopoietic stem-cell
transplant-associated thrombotic microangiopathy.”
Consistent with the safety profile observed in other narsoplimab
studies, results from the interim analysis in ARTEMIS-IGAN indicate
that narsoplimab has been generally well tolerated without any
safety signal of concern.
Conference Call Details
Omeros’ management will host a conference call and webcast to
discuss the results. The call will be held today at 5:30 a.m.
Pacific Time; 8:30 a.m. Eastern Time.
For online access to the live webcast of the conference call, go
to Omeros’ website at
https://investor.omeros.com/upcoming-events.
To access the live conference call via phone, participants must
register at this link to receive a unique PIN. Once registered, you
will have two options: (1) Dial in to the conference line provided
at the registration site using the PIN provided to you, or (2)
choose the “Call Me” option, which will instantly dial the phone
number you provide. Should you lose your PIN or registration
confirmation email, simply re-register to receive a new PIN.
A replay of the call will be made accessible online at
https://investor.omeros.com/archived-events.
About Omeros Corporation
Omeros is an innovative biopharmaceutical company committed to
discovering, developing and commercializing small-molecule and
protein therapeutics for large-market and orphan indications
targeting immunologic disorders including complement-mediated
diseases, cancers, and addictive and compulsive disorders. Omeros’
lead MASP-2 inhibitor narsoplimab targets the lectin pathway of
complement and is the subject of a biologics license application
pending before FDA for the treatment of hematopoietic stem cell
transplant-associated thrombotic microangiopathy (TA-TMA).
Narsoplimab is also in multiple late-stage clinical development
programs focused on other complement-mediated disorders, including
COVID-19. Omeros’ long-acting MASP-2 inhibitor OMS1029 is currently
in a Phase 1 clinical trial. OMS906, Omeros’ inhibitor of MASP-3,
the key activator of the alternative pathway of complement, is
advancing across multiple clinical programs for alternative
pathway-related diseases, including paroxysmal nocturnal
hemoglobinuria (PNH) and complement 3 (C3) glomerulopathy. For more
information about Omeros and its programs, visit
www.omeros.com.
Forward-Looking Statements
This press release contains “forward-looking statements” as that
term is defined in the Private Securities Litigation Reform Act of
1995. Without limiting the foregoing, these statements are often
identified by the words “may”, “might”, “believes”, “thinks”,
“anticipates”, “plans”, “expects”, “intends” or similar
expressions. In addition, expressions of our strategies, intentions
or plans are also forward-looking statements. Such forward-looking
statements include, but are not limited to, references to the
Company’s current and anticipated strategies in relation to its
clinical development programs. Such forward-looking statements are
based on current information available to the Company and involve
inherent risks and uncertainties, including factors that could
delay, divert or change any such forward-looking statements, and
could cause actual outcomes and results to differ materially from
current expectations. No forward-looking statement can be
guaranteed. Among the factors that could cause actual results to
differ materially from those indicated in the forward-looking
statements are risks and uncertainties associated with the
regulatory review and approval process. In addition, such risks and
uncertainties may include those described in the Company’s annual,
quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form
8-K) as filed or furnished with the SEC, which are available at the
Company’s website (www.omeros.com) under “Investors & News”.
You are cautioned not to place undue reliance on any
forward-looking statements as there are important factors that
could cause actual results to differ materially from those in any
forward-looking statements, many of which are beyond our control.
Except to the extent required by law, the Company undertakes no
obligation to publicly update any forward-looking statement.
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version on businesswire.com: https://www.businesswire.com/news/home/20231016616955/en/
Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations IR@omeros.com
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