New zerlasiran data show significant
time-averaged Lp(a) reductions with effects persisting 60 weeks
following the first dose
Represents first study to report time-averaged
Lp(a) results to further evaluate potential clinical benefits
Data simultaneously published in the Journal of
the American Medical Association
Silence Therapeutics plc, Nasdaq: SLN (“Silence” or the
“Company”), a global clinical stage biotechnology company committed
to transforming people’s lives by silencing diseases through
precision engineered medicines, today presented end-of-treatment
data from its Phase 2 ALPACAR-360 study of zerlasiran, a short
interfering RNA (siRNA), in atherosclerotic cardiovascular disease
(ASCVD) patients with high lipoprotein(a) [Lp(a)] levels (≥125
nmol/L). These data were presented during the Late-Breaking Science
Session of the American Heart Association (AHA) Scientific Sessions
2024 in Chicago, Illinois, and simultaneously published in the
Journal of the American Medical Association (JAMA).
Results presented today showed that zerlasiran (300 mg every 16
weeks, 300 mg every 24 weeks or 450 mg every 24 weeks) produced
greater than 80% mean time-averaged placebo-adjusted reductions
from baseline in Lp(a) concentrations over 36 weeks. This is the
first study to report time-averaged Lp(a) analyses, which more
accurately evaluates the effects of treatment over time, including
intervals between doses. Maximum Lp(a) reductions exceeded 90%. At
the final visit, 60 weeks following initial drug administration,
reductions in Lp(a) persisted and no safety concerns emerged with
infrequent dosing.
“These data provide additional information to select the best
dose and dosing interval for future zerlasiran Phase 3 trials,”
said Steven E. Nissen, MD, Chief Academic Officer of the Heart,
Vascular and Thoracic Institute at Cleveland Clinic and the study’s
lead author. “Elevated Lp(a) impacts at least 20% of the global
population and is a major cause for morbidity and mortality
globally. This is a genetic risk factor that we’ve been unable to
treat and I’m excited about the potential for gene-silencing
approaches to help these patients.”
“Additional results from the ALPACAR-360 study continue to
support the competitive profile of zerlasiran on key clinical
endpoints assessing time-averaged reduction, maximum effect and
tolerability,” said Curtis Rambaran, MD, Chief Medical Officer at
Silence. “The Phase 2 data show zerlasiran has the potential to
provide long term reductions in Lp(a) with infrequent dosing. We
look forward to progressing zerlasiran into Phase 3 as a
potentially promising new treatment for patients with high
Lp(a).”
About Lp(a)
Lp(a) is genetically determined1-5 and a presumed independent
risk factor for cardiovascular disease (CVD). Although an
agreed-upon threshold for high Lp(a) is not firmly established,
approximately 20% of adults have Lp(a) >125 nmol/L (or
approximately 50 mg/dL).3,4 Evidence has emerged from
pathophysiological, epidemiologic, and genetic studies on the
potential role of high Lp(a) in contributing to myocardial
infarction, stroke, and peripheral arterial disease.5
About ALPACAR-360
The ALPACAR-360 clinical program was designed to evaluate
Silence’s investigational zerlasiran in patients with
atherosclerotic cardiovascular disease (ASCVD) and high Lp(a)
levels to reduce the risk of cardiovascular events. The ALPACAR-360
trial was a multicenter, randomized, double-blind,
placebo-controlled dose-finding Phase 2 study in 178 patients with
ASCVD and Lp(a) ≥125 nmol/L. Baseline Lp(a) concentration was 213
nmol/L. Patients were randomly assigned to one of three active
subcutaneous doses of zerlasiran (300 mg Q16 weeks, 300 mg Q24
weeks, 450 mg Q24 weeks) or placebo. The primary endpoint was
time-averaged change in Lp(a) from baseline to 36 weeks. Secondary
endpoints included time-averaged changes in LDL-C as well as
time-averaged Lp(a) to 48 weeks (end of treatment period) and 60
weeks (end of study).
About Silence Therapeutics
Silence Therapeutics is a global clinical stage biotechnology
company committed to transforming people’s lives by silencing
diseases through precision engineered medicines created with
proprietary siRNA (short interfering RNA) technology. Silence
leverages its mRNAi GOLD™ platform to create innovative siRNAs
designed to precisely target and silence disease associated genes
in the liver, which represents a substantial opportunity. Silence
focuses on areas of high unmet medical need with programs advancing
in cardiovascular disease, hematology and rare diseases. Silence
also maintains research and development collaborations with
AstraZeneca and Hansoh Pharma, among others. For more information,
please visit https://www.silence-therapeutics.com/.
Forward-Looking Statements
This press release contains “forward-looking statements” within
the meaning of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. These statements may be identified
by words such as “aims,” “anticipates,” “believes,” “could,”
“estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,”
“plans,” “possible,” “potential,” “seeks,” “will” and variations of
these words or similar expressions that are intended to identify
forward-looking statements, although not all forward-looking
statements contain these words. All statements in this press
release, other than statements of historical facts, are
forward-looking statements. Forward-looking statements in this
press release include, but are not limited to, statements
regarding: the Company’s clinical development plans of zerlasiran
including selection of the dose and dosing interval and the
Company’s timing, plans and potential to move into Phase 3
registrational trial; the Company’s ability to create
gene-silencing approaches to help patients with ASCVD and high
Lp(a) levels to reduce the risk of cardiovascular events; and the
potential clinical benefits and efficacy and safety of zerlasiran.
Any forward-looking statements are based on management’s current
expectations and beliefs of future events and are subject to a
number of risks and uncertainties that could cause actual events or
results to differ materially and adversely from those set forth in
or implied by such forward-looking statements, many of which are
beyond the Company’s control. These risks and uncertainties
include, but are not limited to: the impact of worsening
macroeconomic conditions, including the conflict in Ukraine and the
conflict between Israel and Hamas, heightened inflation and
uncertain credit and financial markets, on the Company’s business,
clinical trials and financial position; the risk that success in
preclinical testing and earlier clinical trials is not replicated
in later clinical trials; the delay of any current or planned
clinical trials, whether due to patient enrollment delays or
otherwise; the Company’s ability to successfully demonstrate the
safety and efficacy of its product candidates and gain approval of
its product candidates on a timely basis, if at all; unexpected
safety or efficacy data observed during preclinical studies or
clinical trials; clinical trial site activation or enrollment rates
that are lower than expected; the Company’s ability to realize the
benefits of its collaborations and license agreements; changes in
expected or existing competition; changes in the regulatory
environment; the uncertainties and timing of the regulatory
approval process; and unexpected litigation or other disputes.
These and other risks and uncertainties are identified in the
section titled "Risk Factors" in the Company’s most recent Annual
Report on Form 20-F for the year ended December 31, 2023 filed with
the U.S. Securities and Exchange Commission (the “SEC”) on March
13, 2024 as updated by the section titled “Risk Factors” in the
Company’s Report on Form 6-K filed with the SEC on November 14,
2024 as well as its other documents subsequently filed with or
furnished to the SEC. The Company expressly disclaims any
obligation to update any forward-looking statements contained
herein, whether as a result of any new information, future events,
changed circumstances or otherwise, except as otherwise required by
law.
1 Wilson DP, et al. Clin Lipidol. 2019;13(3):374-92. 2
Reyes-Soffer G, et al. Arterioscler Thromb Vasc Biol.
2022;42(1):e48-e60. 3 Kronenberg F, et al. Eur Heart J.
2022;43(39):3925-3946. 4 Tsimikas S, Stroes ESG. Atherosclerosis.
2020;300:1-9. 5 Tsimikas S, et al. J Am Coll Cardiol.
2018;71(2):177–192.
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version on businesswire.com: https://www.businesswire.com/news/home/20241118316596/en/
Inquiries: Silence Therapeutics plc Gem Hopkins,
VP, Head of IR & Corporate Communications +1 (646) 637-3208
ir@silence-therapeutics.com Media Relations MKC
Strategies Mary Conway +1 (516) 606-6545
mconway@mkcstrategies.com
Silence Therapeutics (NASDAQ:SLN)
過去 株価チャート
から 11 2024 まで 12 2024
Silence Therapeutics (NASDAQ:SLN)
過去 株価チャート
から 12 2023 まで 12 2024
