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Silence Therapeutics PLC
29 April 2021
Silence Therapeutics Announces First Patient Dosed in GEMINI II
Phase I Clinical Trial for SLN124
- First patient dosed in study evaluating Silence's wholly owned
lead product candidate for thalassemia and myelodysplastic syndrome
(MDS)
29 April 2021
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, today announced that the first
patient has been dosed in the GEMINI II Phase I clinical study of
its wholly owned lead product candidate, SLN124, for the treatment
of 'iron-loading' anemias, thalassemia and myelodysplastic syndrome
(MDS).
The first patient was dosed at the Jordan University Hospital,
Amman, Jordan; one of up to 25 trial sites for the global,
multi-center study, which spans Europe, the Middle East and
Southeast Asia.
GEMINI II is a single-blind, randomized, placebo-controlled
study that will enroll up to 112 total participants. It aims to
investigate the safety, tolerability, pharmacokinetic and
pharmacodynamic response of SLN124 in people with thalassemia and
MDS, whose bodies produce fewer healthy red blood cells than normal
and who can store too much iron in their bodies. Interim data is
expected to be reported in the second half of this year.
Giles Campion, MD, EVP, Head of R&D and Chief Medical
Officer of Silence Therapeutics said: "Today's announcement is an
exciting milestone in the development of SLN124. It is the result
of many years of hard work to engineer a durable, precisely
targeted molecule with the aim to reduce anemia by increasing the
naturally occurring hormone, hepcidin - a key regulator of iron
balance in the body. We look forward to evaluating the potential of
SLN124 in the clinic and expect to report interim data from the
single-ascending dose portion of the study in the second half of
this year."
SLN124 has Orphan Drug Designation for both conditions and rare
pediatric disease designation for beta-thalassemia. More
information on the GEMINI II study can be found here .
Silence is also evaluating SLN124 in the GEMINI study in healthy
volunteers. Enrolment in that study is complete and the Company
expects to report top-line data in the first half of this year.
This will be the first-in-human data from Silence's proprietary
mRNAi GOLD(TM) platform. More information on the GEMINI study can
be found here .
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 PR Tel: +44 (0) 20
Consilium Strategic Communications 3709 5700
Mary-Jane Elliott/ Angela Gray / Chris Welsh
silencetherapeutics@consilium-comms.com
About SLN124
SLN124 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, SLN124 aims to
temporarily 'silence' TMPRSS6, a gene that prevents the liver from
producing a particular hormone that controls iron levels in the
body - hepcidin. As hepcidin increases, it is hoped that iron
levels in the blood will decrease, which could in turn allow more
healthy red blood cells to be produced, thereby improving
anemia.
SLN124 is being studied in the GEMINI clinical trial program.
The GEMINI II is a phase 1 study to investigate the effects of
SLN124 in people with thalassemia or myelodysplastic syndrome
(MDS), whose bodies produce fewer healthy red blood cells than
normal and who can store too much iron in their bodies.
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 messenger RNAi GOLD(TM)
platform can be used to create siRNAs 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 iron
loading anemias. Silence also maintains ongoing research and
development collaborations with AstraZeneca, Mallinckrodt
Pharmaceuticals, and Takeda, 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, including with respect to the Company's clinical
development timeline 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, including the
potential impact of COVID-19 on the Company's clinical development
and regulatory timelines and plans. 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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