Silence Therapeutics Announces Positive Topline Results from Phase 1 Multiple Dose Study of Zerlasiran in Subjects with High Lipoprotein(a) and Stable Atherosclerotic Cardiovascular Disease
01 Novembre 2023 - 12:00PM
Business Wire
Zerlasiran showed very significant and
durable reductions in lipoprotein(a) of up to 99%
Lp(a) levels remained around 90% lower than
baseline at study endpoint
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 positive
topline results from the multiple dose component of the APOLLO
phase 1 study of zerlasiran (formerly SLN360) in 36 adults with
baseline lipoprotein(a), or Lp(a), levels at or over 150 nmol/L and
stable atherosclerotic cardiovascular disease (ASCVD). 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 approximately 20% of the world’s population.
In the double-blind placebo-controlled treatment period,
zerlasiran (200 mg, 300 mg and 450 mg) was administered twice
subcutaneously at two different dosing intervals to ASCVD patients.
These data demonstrated a significant reduction from baseline in
Lp(a) of up to 99% at 90 days following injection of repeated
doses. Lp(a) levels remained approximately 90% lower than baseline
at 201 days (end of treatment period) at the two highest doses. A
dose dependent reduction in low-density lipoprotein cholesterol
(LDL cholesterol) and apolipoprotein B (ApoB) was also observed.
Zerlasiran was well tolerated; no clinically important safety
concerns were identified.
“We are extremely pleased to see the excellent results we saw in
healthy volunteers translate to our target population,” said Craig
Tooman, President and CEO of Silence. “Zerlasiran delivered
essentially complete Lp(a) knockdown on repeated dosing with
greater durability than seen with single doses. The safety profile
also continues to be very well suited for chronic use in a very
large global population. We look forward to building on this
dataset with the ongoing phase 2 study expected to readout in the
first half of next year.”
Silence plans to present further results from the APOLLO
multiple dose study at a future cardiovascular medicines
conference.
Results from the single ascending dose portion of the APOLLO
study were simultaneously presented in a late breaker at the 2022
American College of Cardiology (ACC) Annual Meeting and published
in the Journal of the American Medical Association (JAMA),
available here.
Zerlasiran is currently being evaluated in the fully enrolled
ALPACAR-360 phase 2 study in patients with Lp(a) levels at or over
125 nmol/L at high risk of ASCVD events. Silence expects to report
topline 36-week data in the first quarter of 2024 and topline
48-week data in the second quarter of 2024.
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 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/20231101637440/en/
Enquiries: Silence Therapeutics plc Gem Hopkins,
Head of IR and Corporate Communications ir@silence-therapeutics.com
Tel: +1 (646) 637-3208
Grafico Azioni Silence Therapeutics (NASDAQ:SLN)
Storico
Da Mag 2024 a Giu 2024
Grafico Azioni Silence Therapeutics (NASDAQ:SLN)
Storico
Da Giu 2023 a Giu 2024