Silence Therapeutics Completes Enrollment in Phase 2 Study of Zerlasiran (SLN360) in Subjects with Elevated Lipoprotein(a) at High Risk of Atherosclerotic Cardiovascular Disease Events
May 01 2023 - 7:00AM
Business Wire
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 that it has
completed enrollment in the ALPACAR-360 phase 2 study of zerlasiran
(SLN360) in subjects with elevated lipoprotein(a) (“Lp(a)”) at high
risk of atherosclerotic cardiovascular disease (“ASCVD”)
events.
“The fact that it took less than four months to enroll this
trial really speaks to the incredible market opportunity, growing
awareness of Lp(a) as a key cardiovascular risk factor and strong
execution by our team,” said Craig Tooman, President and CEO of
Silence. “We are now tracking well ahead of our original timelines
and currently anticipate reporting topline data in mid-2024.
There’s a great deal of interest and excitement around this
program, and we look forward to providing further updates at the
appropriate time.”
The ALPACAR-360 phase 2 study is evaluating approximately 160
subjects with high Lp(a) ≥ 125 nmol/L at high risk of ASCVD events.
The primary endpoint is time averaged change in Lp(a) from
baseline. In the phase 1 APOLLO single dose study evaluating
healthy volunteers with high Lp(a) ≥ 150 nmol/L, participants who
received zerlasiran (300 mg and 600 mg doses) saw median maximal
Lp(a) reductions of 96% and 98%, respectively. A further analysis
showed median time-averaged reductions during 150 days of follow up
exceeded 80% in 300 mg and 600 mg treatment groups. Zerlasiran was
well tolerated with no serious safety issues identified. The
Company remains on-track to report topline data from the multiple
dose portion of the APOLLO program in the fourth quarter of this
year.
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
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 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 15, 2023. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230501005060/en/
Inquiries: Silence Therapeutics plc Gem Hopkins,
Head of IR and Corporate Communications ir@silence-therapeutics.com
Tel: +1 (646) 637-3208
Silence Therapeutics (NASDAQ:SLN)
Historical Stock Chart
From Apr 2024 to May 2024
Silence Therapeutics (NASDAQ:SLN)
Historical Stock Chart
From May 2023 to May 2024