Silence Therapeutics Announces Positive Topline 36-Week Data from Ongoing Phase 2 Study of Zerlasiran in Patients with High Lipoprotein(a)
13 March 2024 - 10:00PM
Business Wire
Study met primary endpoint and demonstrated
highly significant reductions in Lp(a) to week 36
Lipoprotein(a) reduction was consistent with
phase 1 results
Topline 48-week data expected in 2Q 2024
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 36-week data from the ongoing 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
36 weeks (primary endpoint). Median percentage reduction in Lp(a)
of 90% or greater were observed for both doses at week 36. No new
safety concerns were identified during this treatment period.
The 60-week study is ongoing and secondary endpoints, including
change in Lp(a) from baseline to 48 weeks (end of treatment
period), 60 weeks (end of study) and potential effects on other
lipids/lipoproteins, will be evaluated.
“We are excited about the emerging phase 2 data, which are very
consistent with phase 1 results and support a competitive profile
for treating patients with high Lp(a),” said Steven Romano, MD,
Head of Research and Development at Silence. “We look forward to
reviewing the 48-week data and advancing zerlasiran as a potential
treatment to address this major unmet need in cardiovascular
disease.”
Silence plans to report topline 48-week data from the
ALPACAR-360 study in the second quarter of this year.
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
high levels of lipoprotein(a) and divesiran designed to address
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
Certain statements made in this announcement are forward-looking
statements within the meaning of the U.S. Private Securities
Litigation Reform Act of 1995 and other securities laws, including
with respect to the Company’s cash runway and forecast operating
cash flow, the Company’s clinical and commercial prospects,
regulatory approvals of the Company’s product candidates, potential
partnerships or collaborations or payments under new and existing
collaborations, the initiation or completion of the Company’s
clinical trials and the anticipated timing or outcomes of data
reports from the Company’s clinical trials. These forward-looking
statements are not historical facts but rather are based on the
Company's current assumptions, beliefs, expectations, estimates and
projections about its industry. Words such as “anticipate,”
“expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” and
similar expressions are intended to identify forward-looking
statements. These statements are not guarantees of future
performance and are subject to known and unknown risks,
uncertainties, and other factors, some of which are beyond the
Company's control, are difficult to predict, and could cause actual
results to differ materially from those expressed or forecasted in
the forward-looking statements, including those risks identified in
the Company’s most recent Admission Document and its Annual Report
on Form 20-F filed with the U.S. Securities and Exchange Commission
on March 15, 2023. The Company cautions security holders and
prospective security holders not to place undue reliance on these
forward-looking statements, which reflect the view of the Company
only as of the date of this announcement. The forward-looking
statements made in this announcement relate only to events as of
the date on which the statements are made. The Company will not
undertake any obligation to release publicly any revisions or
updates to these forward-looking statements to reflect events,
circumstances, or unanticipated events occurring after the date of
this announcement except as required by law or by any appropriate
regulatory authority.
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version on businesswire.com: https://www.businesswire.com/news/home/20240313160113/en/
Inquiries: Silence Therapeutics plc Gem Hopkins,
VP, IR and Corporate Communications ir@silence-therapeutics.com
Tel: +1 (646) 637-3208
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