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Silence Therapeutics PLC
16 November 2020
Silence Therapeutics Presents Positive Pre-Clinical Data for
SLN360 for the Treatment of Elevated Lipoprotein(a) at American
Heart Association 2020
- Pre-clinical safety data show no adverse or off-target effects
and targeted biodistribution of the company's wholly owned
gene-silencing candidate SLN360
- Profile supports SLN360's progression to in-human testing for
the treatment of elevated lipoprotein(a), an independent risk
factor for premature heart disease, heart attack and stroke
16 November 2020
LONDON, Silence Therapeutics plc , AIM: SLN and 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, has presented positive pre-clinical
safety data for its wholly owned lead product candidate, SLN360, at
the American Heart Association (AHA)'s virtual Scientific Sessions
2020, being held 14-16 November.(1) The results, available here ,
demonstrated that the potent and sustained reduction of
lipoprotein(a) - Lp(a) - levels in in vitro and animal models
treated with SLN360 was not associated with any adverse or
off-target effects.(1)
Giles Campion, Head of R&D and Chief Medical Officer of
Silence Therapeutics commented: "The strength of our pre-clinical
safety data, coupled with the efficacy data presented at the AHA
congress this time last year, demonstrates the precision with which
we are able to target the appropriate gene and deliver robust
knockdown of Lp(a) levels with long duration of action. Safety is
always important but particularly when a therapy has the potential
to be administered to a large population as a long-term
preventative measure. These results give us confidence to move
SLN360 into the clinic, to develop a transformational medicine for
the millions of people facing a higher risk of cardiovascular
disease due to elevated Lp(a). "
Recent evidence has shown that elevated Lp(a) serum levels is a
key independent, genetic and causal risk factor for premature heart
disease, heart attack and stroke.(2) It is estimated to affect 20%
of individuals worldwide, with limited treatment strategies
currently available. By directly targeting and silencing the LPA
gene within the liver, SLN360 is designed to lower levels of Lp(a),
which in turn is expected to lower the risk of premature
cardiovascular disease.
Results presented today show that the distribution of SLN360 is
confined to the liver (target organ) and kidney (route of
elimination) as intended, with levels of SLN360 in other organs
(including reproductive organs) less than 1% of peak liver levels.
Its restricted biodistribution and the absence of off-target
effects supports the progression of SLN360 to in-human testing.
The Phase I APOLLO trial is now recruiting (NCT04606602), to
investigate the safety, tolerability, pharmacokinetic and
pharmacodynamic response of SLN360 in people with elevated Lp(a).
If successful in clinical trials, SLN360 may provide a novel
therapeutic approach to address Lp(a)-related cardiovascular
disorders. More information on the trial can be found here.
References
1. Rider D, et al. Pre-clinical Safety Assessment of SLN360, A
Novel Short Interfering Ribonucleic Acid Targeting LPA, presented
at the American Heart Association (AHA) Scientific Sessions,
November 2020.
2. Tsimikas S, A Test in Context: Lipoprotein(a): Diagnosis,
Prognosis, Controversies, and Emerging Therapies, J Am Coll
Cardiol. 2017;69(6):692-711.
Enquiries:
Silence Therapeutics plc Tel: +1 (646) 637-3208
Gem Hopkins, Head of IR and Corporate Communications
ir@silence-therapeutics.com
Investec Bank plc (Nominated Adviser and Tel: +44 (0) 20
Broker) 7597 5970
Daniel Adams/Gary Clarence
European IR Tel: +44 (0) 20
Consilium Strategic Communications 3709 5700
Mary-Jane Elliott/Chris Welsh/Angela Gray
silencetherapeutics@consilium-comms.com
U.S. IR Tel: +1 (443) 213-0505
Westwicke Partners
Peter Vozzo
peter.vozzo@westwicke.com
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. Silence is evaluating SLN360 in its APOLLO Phase 1 dose
escalation study designed to assess the safety, tolerability,
pharmacokinetic and pharmacodynamic response of SLN360 in people
with elevated Lp(a). More information on the trial can be found
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
medical need. Silence's proprietary technology can be used to
engineer short interfering ribonucleic acids (siRNAs) that bind
specifically to and silence, through the RNAi pathway, almost any
gene in the human genome to which siRNA can be delivered. 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 to address beta-thalassemia and
myelodysplastic syndrome. Silence is also developing SLN500, a C3
targeting programme, in partnership with Mallinckrodt
Pharmaceuticals to reduce the expression of the C3 protein for the
treatment of complement pathway-mediated diseases. Silence
maintains ongoing research and collaborations with AstraZeneca,
Mallinckrodt Pharmaceuticals and Takeda. For more information,
please visit: https://www.silence-therapeutics.com/
Forward-Looking Statements
Certain statements made in this announcement are forward-looking
statements, including with respect to the Company's clinical and
commercial prospects. These forward-looking statements are not
historical facts but rather are based on the Company's current
expectations, estimates, and projections about its industry; its
beliefs; and assumptions. 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. 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
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