Silence Therapeutics Announces JAMA Publication of Additional Phase 1 Data for Zerlasiran in Subjects with Elevated Lipoprotein(a)
08 April 2024 - 5:48PM
Business Wire
Published findings demonstrate zerlasiran was
well-tolerated and significantly reduced Lp(a) after single and
multiple dosing
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 additional
results from the APOLLO phase 1 study of zerlasiran (SLN360) in
subjects with baseline lipoprotein(a), or Lp(a), levels at or over
150 nmol/L were published in the Journal of the American Medical
Association (JAMA), linked here.
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.
“Positive phase 1 data published in JAMA demonstrate treatment
with zerlasiran produced sustained reductions in Lp(a)
concentrations with a well-tolerated profile using varying dosing
regimens,” said Curtis Rambaran, MD, Chief Medical Officer at
Silence and senior author of the publication. “The promising
findings from this study are particularly encouraging as we
complete the phase 2 study for zerlasiran and underscore our
commitment to address this major unmet need in cardiovascular
disease.”
The single ascending and multiple dose trial enrolled 32 healthy
participants and 36 patients with atherosclerotic cardiovascular
disease (ASCVD) and Lp(a) concentrations ≥150 nmol/L. Results from
the single ascending dose portion of the trial in healthy
participants were previously published in the April 2022 issue of
JAMA, linked here. Today’s JAMA publication reviews findings from
the extended 365 day follow up of healthy participants who received
the two highest zerlasiran doses (300 or 600 mg) and 201 days of
follow up for ASCVD patients administered 2 doses.
Healthy participants were randomized and received a single
subcutaneous dose of placebo, 300 mg or 600 mg; ASCVD patients
received two doses of placebo, 200 mg at a 4-week interval or 300
mg or 450 mg at an 8-week interval. The primary outcome was safety
and tolerability. Secondary outcomes included the serum levels of
zerlasiran and effects on Lp(a) serum concentrations.
Zerlasiran was safe and well tolerated. The median change from
baseline in serum Lp(a) concentrations 365 days after single doses
for placebo, 300 mg, and 600 mg were +14%, −30%, and −29%
respectively. The maximal median change from baseline after two
doses of placebo, 200 mg, 300 mg and 450 mg were +7%, -97%, -98%
and -99%, attenuating to 0.3%, -60%, 90% and 89% respectively,
after 201 days.
Zerlasiran is currently being evaluated in the ALPACAR-360 phase
2 study in subjects with baseline Lp(a) levels at or over 125
nmol/L at high risk of ASCVD events.
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 13, 2024. 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/20240408451903/en/
Inquiries: Silence Therapeutics plc Gem Hopkins,
VP, 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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