Silence Therapeutics Presents New Analysis from SLN360 Phase 1 Single Dose Study in High Lipoprotein(a) at the American Heart Association (AHA) 2022 Annual Meeting
November 05 2022 - 10:30AM
Business Wire
– Assessment showed participants who
received a single dose of SLN360 maintained median reductions over
80% over a five-month period
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 presented data from
an analysis of its APOLLO phase 1 single dose study of SLN360, an
investigational short interfering ribonucleic acid (“siRNA”), in
healthy adults with high lipoprotein(a) (“Lp(a)”), a key genetic
risk factor for heart disease, at the American Heart Association
(“AHA”) 2022 Annual Meeting.
The moderated poster entitled, “Time Averaged Lipoprotein(a)
Reduction with SLN360, A Novel SiRNA Targeting Lp(a) in Healthy
Adults with Elevated Lp(a),” assessed Lp(a) levels of participants
in the APOLLO single dose study during five months of follow
up.
In the top two SLN360 single dose groups (300 mg and 600 mg),
median time-averaged Lp(a) reductions over 150 days exceeded 80%.
At day 365, some participants still exhibited substantial knockdown
of Lp(a) to approximately 50% of baseline. Additionally, extension
data to day 365 showed no new drug related safety findings in
either dose group.
Primary safety, tolerability and Lp(a) lowering effects from the
APOLLO single dose study were presented earlier this year and
published in the Journal of the American Medical Association
(“JAMA”). In the trial, participants who received single doses of
SLN360 (300 mg or 600 mg) saw median maximal reductions of 96% and
98% respectively.
High Lp(a) is estimated to affect up to 20% of the world’s
population and is a known, independent risk factor for
cardiovascular disease. There are no approved medicines that
selectively lower Lp(a).
“These findings suggest that SLN360 has the potential to sustain
meaningful reductions in Lp(a) levels with infrequent dosing,” said
Curtis Rambaran, MD, lead author of the poster and Head of Clinical
Science at Silence. “High Lp(a) is a very common, genetically
determined risk factor that can lead to premature heart attack,
stroke and aortic stenosis. We remain encouraged by the profile
SLN360 has shown and look forward to evaluating further in the
clinic.”
Silence is evaluating SLN360 in the multiple dose portion of the
APOLLO phase 1 study in patients with stable atherosclerotic
cardiovascular disease (“ASCVD”) and high Lp(a). The Company plans
to initiate the SLN360 phase 2 ASCVD study in the second half of
2022, pending regulatory discussions.
About SLN360
Silence’s wholly owned lead product candidate, SLN360, is a gene
‘silencing’ therapy – one that is designed to temporarily block a
specific gene’s message that would otherwise trigger an unwanted
effect. In this case, it aims to ‘silence’ LPA, a gene that tells
the body to make a specific protein that is only found in Lp(a). By
silencing LPA, the levels of Lp(a) are lowered, which in turn is
expected to lower the risk of heart diseases, heart attacks and
strokes. SLN360 is being studied in the APOLLO clinical trial
program. For more information about the APOLLO study, please click
here.
About Lipoprotein(a)
Lipoprotein(a), known as Lp(a) for short, is a particle made by
the liver, which consists of cholesterol, fats and proteins. Most
people have some Lp(a) in their body, but about 1 in 5 people have
high levels of Lp(a), because of a specific gene variation in their
DNA. Most people are unaware if they have elevated Lp(a). People
living with elevated Lp(a) have a higher risk of developing early
heart disease, heart attacks and strokes. Most standard cholesterol
tests do not currently include screening for Lp(a). Current
medicines that are used to lower other lipid levels in the blood do
not have a meaningful effect on Lp(a) and are less effective
overall in people with high levels of Lp(a).
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 SLN360 designed to address the high and prevalent unmet
medical need in reducing cardiovascular risk in people born with
high levels of lipoprotein(a) and SLN124 designed to address rare
hematological diseases. Silence also maintains ongoing research and
development collaborations with AstraZeneca, Mallinckrodt
Pharmaceuticals, 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 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 'anticipates,'
'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,'
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
(the “SEC”) on March 17, 2022. 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/20221105005027/en/
Enquiries: Silence Therapeutics plc Gem Hopkins,
Head of IR and Corporate Communications Tel: +1 (646) 637-3208
ir@silence-therapeutics.com Media Relations MKC
Strategies Mary Conway Tel: +1 (516) 606-6545
mconway@mkcstrategies.com
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