Silence Therapeutics Announces Positive Topline 48-Week Data from Phase 2 Study of Zerlasiran in Patients with Elevated Lipoprotein(a)
20 June 2024 - 9:30PM
Business Wire
Study demonstrated highly significant and
sustained reductions in Lp(a) to week 48
Data support advancing zerlasiran into phase 3
with 300 mg dose
Silence Therapeutics plc, Nasdaq: SLN (“Silence” or the
“Company”), an experienced and innovative biotechnology company
committed to transforming people’s lives by silencing diseases
through precision engineered medicines, today announced positive
topline 48-week data from the ALPACAR-360 phase 2 study of
zerlasiran (SLN360) in 178 subjects with baseline lipoprotein(a),
or Lp(a), levels at or over 125 nmol/L at high risk of
atherosclerotic cardiovascular disease (ASCVD) events. Zerlasiran
is a siRNA (short interfering RNA) designed to lower the body’s
production of Lp(a), a key genetic risk factor for cardiovascular
disease affecting up to 20% of the world’s population.
In the double-blind placebo-controlled treatment period,
zerlasiran was administered at 300 mg subcutaneously every 16 or 24
weeks and 450 mg every 24 weeks to patients with a median baseline
Lp(a) of approximately 215 nmol/L. These data demonstrated a highly
significant reduction from baseline in Lp(a) compared to placebo to
48 weeks (end of treatment and dosing period). Median maximum Lp(a)
reduction of approximately 90% or greater was observed for both
doses during the treatment period. Zerlasiran was well tolerated
with no serious safety concerns. As previously announced, the study
met its primary endpoint with a highly significant reduction from
baseline in Lp(a) compared to placebo to 36 weeks. The study is
ongoing, and patients will be followed through to week 60 (end of
study).
“We are encouraged by the strength of the phase 2 data and
emerging competitive profile of zerlasiran, which support an
infrequent dosing regimen of at least quarterly with the 300 mg
dose,” said Steven Romano, MD, Head of Research and Development at
Silence. “We look forward to advancing zerlasiran to phase 3 as a
potential treatment for this major unmet need in cardiovascular
disease.”
The Company plans to provide full results at a future scientific
meeting or publication following completion of the study.
About Silence Therapeutics Silence Therapeutics is
developing a new generation of medicines by harnessing the body's
natural mechanism of RNA interference, or RNAi, to inhibit the
expression of specific target genes thought to play a role in the
pathology of diseases with significant unmet need. Silence's
proprietary mRNAi GOLD™ platform can be used to create siRNAs
(short interfering RNAs) that precisely target and silence
disease-associated genes in the liver, which represents a
substantial opportunity. Silence's wholly owned product candidates
include zerlasiran designed to address the high and prevalent unmet
medical need in reducing cardiovascular risk in people born with
elevated levels of lipoprotein(a) and divesiran designed to address
rare hematological diseases, including polycythemia vera. Silence
also maintains ongoing 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 Private
Securities Litigation Reform Act of 1995. All statements in this
press release other than statements of historical facts are
“forward-looking statements. 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. Forward-looking statements in this
press release include, but are not limited to, statements
regarding: the Company’s clinical development plans of zerlasiran;
the assessment of the data from the ALPACAR-360 study of
zerlasiran; the efficacy and safety of zerlasiran; the estimated
world’s [adult population] who have Lp(a), a key genetic risk
factor for cardiovascular disease; the Company’s plans to advance
zerlasiran into a Phase 3 registrational program in patients with
baseline Lp(a); the potential clinical benefits of zerlasiran; and
the Company’s plans to submit additional data from the ALPACAR-360
study for publication at a conference or in a peer-reviewed
journal. These forward-looking statements are based on the
Company’s expectations and assumptions as of the date of this press
release. Each of these forward-looking statements involves risks
and uncertainties that could cause the Company’s clinical
development programs, future results or performance to differ
materially from those expressed or implied by the forward-looking
statements. Many factors may cause differences between current
expectations and actual results, including: the potential that
success in preclinical testing and earlier clinical trials does not
ensure that later clinical trials will generate the same results or
otherwise provide adequate data to demonstrate the efficacy and
safety of a product candidate; the impacts of 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; 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. Other factors that may cause the Company’s actual
results to differ from those expressed or implied in the
forward-looking statements in this press release are identified in
the section titled "Risk Factors" in the Company’s 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
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240620544030/en/
Inquiries: Silence Therapeutics plc Gem Hopkins,
VP, IR and Corporate Communications ir@silence-therapeutics.com +1
(646) 637-3208
Silence Therapeutics (NASDAQ:SLN)
Historical Stock Chart
From Dec 2024 to Dec 2024
Silence Therapeutics (NASDAQ:SLN)
Historical Stock Chart
From Dec 2023 to Dec 2024