Silence Therapeutics and Mallinckrodt Announce Submission of Clinical Trial Application for SLN501
March 23 2022 - 7:00AM
Business Wire
Silence to receive $3 million research
milestone payment from Mallinckrodt
Phase 1 study expected to begin in the first
half of 2022
Silence Therapeutics plc (Nasdaq: SLN), 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, and Mallinckrodt plc
(OTCMKTS:MNKKQ), a global biopharmaceutical company, today
announced filing of a clinical trial application (CTA) for SLN501,
an siRNA targeting the complement C3 protein, triggering a $3
million milestone payment to Silence.
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Craig Tooman, President and Chief Executive Officer at
Silence, commented: “The CTA submission for SLN501 represents
another key milestone in our Mallinckrodt collaboration leveraging
our proprietary mRNAi GOLD™ platform for complement-mediated
diseases. This highlights the importance of partnerships to expand
our pipeline opportunities while also providing non-dilutive
financing to support our development activities.”
Mark Trudeau, President and Chief Executive Officer of
Mallinckrodt, said: “We remain excited about the potential of
Silence’s mRNAi GOLD™ platform to address the unmet needs of
patients suffering from a range of complement-mediated diseases. We
look forward to entering into the clinic with our first product
candidate, SLN501, in the first half of this year as well as
progressing work on two other complement targets.”
Under the collaboration, Silence is responsible for executing
the development program for SLN501 until the end of phase I, after
which Mallinckrodt will assume responsibility for clinical
development and global commercialization. The phase I study is
expected to start in the first half of 2022.
In July 2019, Silence and Mallinckrodt initiated a collaboration
focused on leveraging Silence’s proprietary mRNAi GOLD™ platform to
develop siRNAs for complement-mediated diseases. Under the
agreement, Silence received an upfront payment of $20 million from
Mallinckrodt for an exclusive worldwide license to siRNAs developed
against one complement target, C3, and options to license siRNAs
against up to two additional complement targets, each of which
Mallinckrodt exercised in 2021 at $2 million per target. Silence is
responsible for preclinical activities and for executing
development of each target through phase 1, after which
Mallinckrodt will assume responsibility for clinical development
and global commercialization. Silence is also eligible to receive
tiered double-digit royalties on net sales for each product
candidate and up to $2 billion in total milestone payments across
all three targets.
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 rare
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/.
About Mallinckrodt Mallinckrodt is a global business
consisting of multiple wholly owned subsidiaries that develop,
manufacture, market and distribute specialty pharmaceutical
products and therapies. The company's Specialty Brands reportable
segment's areas of focus include autoimmune and rare diseases in
specialty areas like neurology, rheumatology, nephrology,
pulmonology, ophthalmology, and oncology; immunotherapy and
neonatal respiratory critical care therapies; analgesics; cultured
skin substitutes and gastrointestinal products. Its Specialty
Generics reportable segment includes specialty generic drugs and
active pharmaceutical ingredients. To learn more about
Mallinckrodt, visit www.mallinckrodt.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 clinical and
commercial prospects and the anticipated timing of data reports
from the clinical trials. These forward-looking statements are not
historical facts but rather are based on current expectations,
estimates, and projections about the industry; 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 companies’ 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 from time to time in filings the
Company and/or Mallinckrodt make with the U.S. Securities and
Exchange Commission (“SEC”), including in the Company’s most recent
Admission Document and its Annual Report on Form 20-F filed with
the SEC on March 17, 2022 and/or Mallinckrodt’s most recent Annual
Report on Form 10-K and other filings with the SEC. Each company
cautions security holders and prospective security holders not to
place undue reliance on these forward-looking statements, which
reflect the view of each 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 companies 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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Silence Therapeutics plc Gem Hopkins, Head of IR and
Corporate Communications ir@silence-therapeutics.com Tel: +1 (646)
637-3208 US Media Relations MKC STRATEGIES, LLC Mary
Conway MConway@MKCStrategies.com Tel: +1 (516) 606-6545
Mallinckrodt Investor
Relations Daniel J. Speciale Global Corporate
Controller & Chief Investor Relations Officers
Daniel.speciale@mnk.com Jamie Tinsley H+K Strategies
jamie.tinsley@hkstrategies.com M: +1 713 301 4874 Ron
Bartlett H+K Strategies ron.bartlett@hkstrategies.com M:
+1 813 545 2399
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