- The first healthy volunteer has been dosed in the first
component of the Phase 1 study
- Initial safety and pharmacokinetic data expected in Q4
2024
- Initiation of the second component of the Phase 1 study, in
adult DMD patients, expected in Q1 2025
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, announced today that the first participant
has been dosed in a Phase 1 clinical study of SAT-3247. SAT-3247 is
a novel, oral small molecule drug targeting AAK1 that is designed
to regenerate skeletal muscle in Duchenne muscular dystrophy (DMD
or Duchenne) and other degenerative or injury conditions involving
muscle tissue.
"We are excited to announce the dosing of the first participants
in our Phase 1 clinical trial of SAT-3247, transforming Satellos
into a clinical stage company. This milestone marks a significant
step in our commitment to developing innovative therapies to
regenerate muscle for those living with Duchenne and other muscle
degenerative or injury conditions," said Frank Gleeson, Co-founder
and CEO, Satellos. "We look forward to advancing this trial and
gaining valuable insights into the safety and pharmacological
profile of SAT-3247."
The Phase 1 clinical trial will comprise two components. In the
first component, 72 healthy volunteers will be enrolled in a
blinded, randomized, placebo-controlled, staggered, parallel design
study to assess the safety and pharmacokinetic properties of
SAT-3247. Participants will be randomized across five
single-ascending dose (SAD) cohorts, four multiple-ascending dose
(MAD) cohorts, and one food effect dose cohort. In the second
component, expected to begin in late Q4 2024, 10 adult volunteers
with genetically confirmed DMD will be enrolled in a 28-day,
open-label, single dose cohort to assess safety and pharmacokinetic
properties in patients and explore potential 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 or
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
MyoReGenXTM, 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 clinical 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 expected structure and progress of our
clinical trials and any potential insights or results that may be
obtained from them; the general benefits of modulating stem cell
polarity by administering small molecule drugs, including our lead
drug candidate; 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 our
lead drug candidate and of regenerating muscle by modulating
polarity generally; 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240918008946/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
Satellos Bioscience (TSX:MSCL)
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