– SLN360 reduced Lp(a) – a key genetic risk
factor for heart disease - by up to 98% with reductions of up to
81% persisting at 150 days
– Results were simultaneously published in
The Journal of the American Medical Association (JAMA)
Silence Therapeutics plc, Nasdaq: SLN (“Silence” or “the
Company”), a leader in the discovery, development and delivery of
novel short interfering ribonucleic acid (siRNA) therapeutics for
the treatment of diseases with significant unmet medical need,
today presented detailed results from its phase 1 APOLLO trial that
showed SLN360, an investigational siRNA, reduced levels of
lipoprotein(a) (“Lp(a)”), an important genetic risk factor for
heart disease, by up to 98% in healthy adults with high Lp(a).
Findings from the “APOLLO Trial: Magnitude and Duration of
Effects of a Short-interfering RNA Targeting Lipoprotein(a): A
Placebo-controlled Double-blind Dose-ranging Trial” were presented
today during a Late Breaking Science Session at the American
College of Cardiology’s 71st Annual Scientific Session (ACC.22) and
simultaneously published online in the Journal of the American
Medical Association, linked here.
“We thought it would work, but we were surprised by the
magnitude and the duration of the effect,” said Steven E. Nissen,
M.D., Chief Academic Officer of the Heart, Vascular and Thoracic
Institute at Cleveland Clinic and the study’s lead author.
“Lipoprotein(a) is the last frontier in lipids, and there has never
been a treatment that’s been shown to benefit these patients. These
findings from the APOLLO study support further development of
SLN360.”
High Lp(a) affects around 20% of the world’s population and is
associated with a high risk of heart attack, stroke and aortic
stenosis. There are no approved medicines that selectively lower
Lp(a). SLN360 is a siRNA that is designed to lower Lp(a) production
by targeting messenger RNA transcribed from the LPA gene.
The phase 1 APOLLO trial evaluated SLN360 in 32 adults at five
medical centers in the U.S., UK and Netherlands. All participants
had plasma concentrations at screening of Lp(a) ≥150 nmol/L with a
median level of 224 nmol/L (75 nmol/L or less is considered
normal). Individuals were randomly assigned to receive a single
subcutaneous dose of SLN360 (30 mg, 100 mg, 300 mg or 600 mg) or
placebo and were observed closely for the first 24 hours, then
periodically assessed for 150 days.
There were no serious safety concerns reported and the most
common side effect was temporary redness at the injection site.
Participants receiving 300 mg and 600 mg of SLN360 had up to 96%
and 98% median reduction in Lp(a) levels, respectively, and median
reductions of up to 71% and 81% from baseline persisted at 150
days. Those receiving a placebo saw no change in Lp(a) levels. The
study follow-up period has been extended to 365 days to further
assess the duration of action.
Other efficacy measures included the effects of SLN360 on
low-density lipoprotein cholesterol (LDL cholesterol) and
apolipoprotein B (ApoB), both of which are associated with an
increased risk of cardiovascular events. The highest doses of
SLN360 reduced LDL cholesterol and ApoB by about 25%.
“These first-in-human data for SLN360 demonstrate its potential
to address a major unmet need in cardiovascular disease affecting 1
in 5 people worldwide,” said Giles Campion, MD, EVP, Head of
R&D and Chief Medical Officer at Silence. “The study showed
SLN360 was well tolerated and substantially reduced Lp(a) levels
with long lasting effects. We remain very encouraged by these data
and look forward to further evaluating SLN360 in the clinic.”
Silence is evaluating SLN360 in the multiple-ascending dose
portion of the APOLLO phase 1 study in patients with high Lp(a)
that have a confirmed history of stable atherosclerotic
cardiovascular disease (“ASCVD”). Silence 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, 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/20220403005043/en/
Enquiries: Silence Therapeutics plc Gem Hopkins,
Head of IR and Corporate Communications +1 (646) 637-3208
ir@silence-therapeutics.com
Media Relations MKC Strategies Mary Conway +1
(516) 606-6545 mconway@mkcstrategies.com
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