– Investigational New Drug (IND) enabling
preclinical and toxicology studies successfully completed
– Initiation of 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 submission on July 10,
2024, 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.
“We view this as a transformative development for Satellos as we
become a clinical-stage company,” said Frank Gleeson, CEO and
Co-founder of Satellos. “Our team is proud to have reached this
important milestone on the timeline we have been working towards
for the past year and see this achievement as a catalyst towards a
steady cadence of milestones to come.”
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) and other
degenerative or injury conditions. Subject to approval by the HREC
and acceptance of the CTN by Australia’s TGA, the Phase 1 clinical
trial is intended to enroll healthy volunteers to assess the safety
and pharmacokinetic properties of SAT-3247. Following completion of
this portion of its program, if successful, Satellos plans to
advance SAT-3247 into clinical trials with DMD patients commencing
in early 2025.
"We are pleased with the results from our preclinical studies
and look forward to initiating clinical development of SAT-3247,”
said Phil Lambert, Ph.D., Chief Scientific Officer of Satellos.
“Prior to submitting our regulatory documentation, we conducted our
preclinical and toxicology studies to the standards of relevant
global regulatory bodies. Thus, we expect to be able to leverage
these results for additional Phase 1 and subsequent clinical trials
in Australia and further jurisdictions including the United States
and Canada, where we plan to advance into trials with DMD
patients."
About SAT-3247
SAT-3247 is an oral, small molecule drug candidate designed to
target the root cause of muscle loss in degenerative diseases,
initially in Duchenne. SAT-3247 presents a novel mechanism of
action to restore impaired muscle regeneration caused by the
absence of functional dystrophin.
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
anticipated benefits to patients from a small molecule treatment
for Duchenne; the advancement of our lead drug candidate into
clinical trials; our belief that filing the regulatory application
will be a catalyst towards a steady cadence of milestones to come;
our belief that we can leverage the results from our preclinical
and toxicology studies for additional clinical trials; the
pharmacodynamic properties and mechanism-of-action of our lead drug
candidate; the potential of our approach in other degenerative
muscle diseases or in muscle injury or trauma; 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/20240711270123/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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