Satellos Announces Completed Enrollment of all Four Multiple-Ascending Dose Cohorts for the Phase 1 Clinical Trial of SAT-3247 in Healthy Volunteers
10 February 2025 - 11:00PM
Business Wire
- Company remains on track to report Phase 1a
data from both the Single- and Multiple-Ascending Dose (SAD and
MAD) cohorts in the healthy volunteer portion of the study in 1Q
2025 at an upcoming major medical meeting
- The Phase 1b portion of the trial, in DMD
patients, is underway with the intention of enrolling up to 10
adult volunteers with genetically confirmed DMD during 1Q 2025
- Phase 2 IND filing on track to be submitted
by end of 1Q 2025
Satellos Bioscience Inc. (TSX: MSCL, OTCQB: MSCLF)
(“Satellos” or the “Company”), a public biotech
company developing new small molecule therapeutic approaches to
improve the treatment of muscle diseases and disorders, today
announced it has completed enrollment of all four
multiple-ascending dose (MAD) cohorts for the Phase 1 clinical
trial of SAT-3247 in healthy volunteers.
“The completion of healthy volunteer enrollment in our Phase 1
trial marks a significant milestone in our mission to develop
transformative therapies for patients with degenerative diseases,”
said Frank Gleeson, Satellos Co-founder and CEO. “We believe
SAT-3247 represents a novel, well-tolerated, and more favorable
treatment option as an oral, once-daily therapy designed to restore
muscle regeneration and repair in all DMD patients, whether used as
a stand-alone drug or an add-on therapy. This progress sets the
stage for us to present the first Phase 1 data at an upcoming major
medical conference and advances our commitment to deliver
meaningful solutions to the DMD community.”
About Phase 1 DMD Trial
The Phase 1 clinical trial is comprised of two components. In
the first component, 72 healthy volunteers have been enrolled in a
blinded, randomized, placebo-controlled, staggered, parallel design
study to assess the safety and pharmacokinetic properties of
SAT-3247. Participants were randomized across five SAD cohorts,
four MAD cohorts, and one food effect dose cohort. The second
component, the Phase 1b portion of the trial, is currently ongoing.
Up to 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 Satellos Bioscience Inc.
Satellos is a clinical-stage drug development company dedicated
to developing life-improving medicines to treat degenerative muscle
diseases. Satellos has invented SAT-3247 as a first-of-its-kind,
orally administered small molecule drug designed to restore
skeletal muscle regeneration in degenerative or injury conditions
by correcting muscle stem cell polarity. Satellos has generated a
body of preclinical evidence with SAT-3247 to support its discovery
that correcting muscle stem cell polarity has the potential to
restore skeletal muscle regeneration to repair and strengthen
muscle that has degenerated or been damaged. SAT-3247 is currently
in clinical development as a potential disease-modifying treatment
initially for DMD. Additionally, Satellos is leveraging its
breakthrough research and proprietary discovery platform
MyoReGenX™, to identify additional degenerative muscle diseases or
injury conditions where deficits in muscle regeneration occur that
are amenable to therapeutic intervention for future clinical
development. 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 expected timing for the presentation of
Phase 1 data and the filing of the Phase 2 IND; the expectations
regarding enrollment in the Company's Phase 1b trial; the potential
for SAT-3247 to represent a disease modifying approach to the
therapeutic treatment of people living with Duchenne; anticipated
benefits to patients from a small molecule treatment for Duchenne;
the advancement SAT-3247 through clinical trials; the
pharmacodynamic properties and mechanism-of-action of SAT-3247; 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; 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/20250210946404/en/
Investors: Liz Williams, CFO, ir@satellos.com
Media: Jessica Yingling, Ph.D., jessica@litldog.com
Clinical Trial Info: medicalinfo@satellos.com
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