Dosing of first participant in a Phase 1
clinical trial of SAT-3247 anticipated in Q3 2024
Satellos Bioscience Inc. (“Satellos” or the “Company”) (TSX:
MSCL, OTCQB: MSCLF), a public biotech company developing new small
molecule therapeutic approaches to improve the treatment of muscle
diseases and disorders, today announced acceptance of a clinical
research proposal to a Human Research Ethics Committee (HREC) in
Australia seeking regulatory authorization under their Therapeutic
Goods Administration’s (TGA’s) Clinical Trial Notification (CTN)
scheme to conduct a first-in-human Phase 1 clinical trial of
SAT-3247.
“Receiving clearance to commence clinical development of
SAT-3247 represents a watershed moment for Satellos as we advance
the first small molecule drug of its kind with the potential to
restore the innate muscle regeneration and repair process that we
discovered is dysfunctional in people living with Duchenne,” said
Frank Gleeson, CEO and Co-founder of Satellos. “We are excited to
be advancing SAT-3247 into first-in-human studies and begin this
next important chapter for Satellos in developing an oral pill
which we believe has the potential to be disease modifying.”
The Phase 1 clinical trial will comprise two components. In the
first component of the study, 72 healthy volunteers will be
enrolled in a blinded, randomized, placebo-controlled, staggered,
parallel design to assess the safety and pharmacokinetic properties
of SAT-3247. Participants will be randomized across 5
single-ascending dose (SAD) cohorts, 4 multiple-ascending dose
(MAD) cohorts and one food effect (FE) dose cohort. In the second
component of the study, 10 adult volunteers with genetically
confirmed DMD will be enrolled in a 28-day, open-label dose cohort
to compare safety and pharmacokinetic properties with the healthy
volunteer data and explore pharmacodynamic markers.
About SAT-3247
SAT-3247 is a proprietary, oral small molecule drug being
developed by Satellos as a novel treatment to regenerate skeletal
muscle which is lost in Duchenne muscular dystrophy (DMD of
Duchenne) and other degenerative or injury conditions. Satellos is
advancing SAT-3247 as a potential treatment for DMD, independent of
dystrophin and regardless of exon mutation status.
About Duchenne Muscular Dystrophy
Duchenne muscular dystrophy is an inherited disease caused by
mutations in the dystrophin gene that no longer allow the
dystrophin protein to function properly. Consequently, as
discovered by Satellos, muscle repair and regeneration are
impaired. Satellos designed SAT-3247 to restore the process of
muscle repair and regeneration by regulating a
dystrophin-independent pathway with the goal of increasing muscle
function. SAT-3247 is intended to work as a standalone therapeutic
without regard to a patient’s genetic mutation or ambulatory
status. Our approach has the potential to complement approaches
designed to restore dystrophin production.
About Satellos Bioscience Inc.
Satellos is a publicly traded biotechnology company dedicated to
developing life-improving medicines to treat degenerative muscle
diseases. Satellos has incorporated breakthrough research in muscle
stem cell polarity into a proprietary discovery platform, called
MyoReGenX™, to identify degenerative muscle diseases where deficits
in this process affect muscle regeneration and are amenable to
therapeutic intervention. With this platform, Satellos is building
a pipeline of novel therapeutics to correct muscle stem cell
polarity and promote the body’s innate muscle repair and
regeneration process. The Company’s lead program is an oral, small
molecule drug candidate in development as a potential
disease-modifying treatment for Duchenne muscular dystrophy.
Satellos is headquartered in Toronto, Ontario. For more
information, visit www.satellos.com.
Notice on Forward-Looking Statements
This press release includes forward-looking information or
forward-looking statements within the meaning of applicable
securities laws regarding Satellos and its business, which may
include, but are not limited to, statements regarding the value of
our DMD program; the advancement of our lead drug candidate into
clinical trials; the general benefits of modulating stem cell
polarity by administering small molecule drugs; its/their
prospective impact on Duchenne patients, patients with other
degenerative muscle disease or muscle injury or trauma, and on
muscle regeneration generally; the utility of regenerating muscle
by modulating polarity; adoption of Satellos’ approach by the
medical community; and Satellos’ technologies and drug development
plans. All statements that are, or information which is, not
historical facts, including without limitation, statements
regarding future estimates, plans, programs, forecasts,
projections, objectives, assumptions, expectations or beliefs of
future performance, occurrences or developments, are
“forward-looking information or statements.” Often but not always,
forward-looking information or statements can be identified by the
use of words such as “shall”, “intends”, “anticipate”, “believe”,
“plan”, “expect”, “intend”, “estimate”, “anticipate”, “potential”,
“prospective” , “assert” or any variations (including negative or
plural variations) of such words and phrases, or state that certain
actions, events or results “may”, “might”, “can”, “could”, “would”
or “will” be taken, occur, lead to, result in, or, be achieved.
Such statements are based on the current expectations and views of
future events of the management of the Company. They are based on
assumptions and subject to risks and uncertainties. Although
management believes that the assumptions underlying these
statements are reasonable, they may prove to be incorrect. The
forward-looking events and circumstances discussed in this release,
may not occur and could differ materially as a result of known and
unknown risk factors and uncertainties affecting the Company,
including, without limitation, risks relating to the pharmaceutical
and bioscience industry (including the risks associated with
preclinical and clinical trials and regulatory approvals), and the
research and development of therapeutics, the results of
preclinical and clinical trials, general market conditions and
equity markets, economic factors and management’s ability to manage
and to operate the business of the Company generally, including
inflation and the costs of operating a biopharma business, and
those risks listed in the “Risk Factors” section of Satellos’
Annual Information Form dated March 26, 2024 (which is located on
Satellos’ profile at www.sedarplus.ca). Although Satellos has
attempted to identify important factors that could cause actual
actions, events or results to differ materially from those
described in forward-looking statements, there may be other factors
that cause actions, events or results to differ from those
anticipated, estimated or intended. Accordingly, readers should not
place undue reliance on any forward-looking statements or
information. No forward- looking statement can be guaranteed.
Except as required by applicable securities laws, forward-looking
statements speak only as of the date on which they are made and
Satellos does not undertake any obligation to publicly update or
revise any forward-looking statement, whether resulting from new
information, future events, or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20240819805151/en/
Investors: Liz Williams, ir@satellos.com Business Development:
Ryan Mitchell, Ph.D., bd@satellos.com Media: Jessica Yingling,
Ph.D., jessica@litldog.com, +1.858.344.8091
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