- The drug target for the Duchenne program is AAK1, a protein
kinase in the Notch pathway, which the Company discovered can be
modulated to enable muscle regeneration
- Satellos is conducting IND-enabling studies and GMP
manufacturing, nominates SAT-3247 as lead drug candidate, files
patent applications for its drug target and drug development
candidates, and remains on track to initiate clinical development
in mid-2024
- The Company has appointed Ms. Courtney Wells, a 20-year
industry veteran with Duchenne clinical trial experience, as Senior
Vice President, Clinical Development Operations to lead and execute
the Company’s clinical development plan
Satellos Bioscience Inc. (“Satellos” or the “Company”) (TSXV:
MSCL) (OTCQB: MSCLF), a publicly traded biotech company developing
new small molecule therapeutic approaches to improve the treatment
of muscle diseases and disorders, announced today the following
updates: AAK1 is the drug target of the Company’s lead drug program
in Duchenne muscular dystrophy (“Duchenne” or “DMD”); IND-enabling
studies and GMP manufacturing are ongoing; SAT-3247 has been
nominated as its lead drug candidate; intellectual property
applications have been filed to seek protection for the Company’s
target and small molecule discoveries; and Ms. Courtney Wells has
been appointed as Senior Vice President, Clinical Development
Operations.
Frank Gleeson, Cofounder and CEO of Satellos, said, “Deploying
our proprietary MyoReGenXTM screening platform, we identified AAK1
as having the potential to affect muscle regeneration by regulating
asymmetric muscle stem cell polarity, independent of dystrophin. We
have generated multiple series of small molecule inhibitors of AAK1
with pharmaceutical properties designed to meet our therapeutic
objectives in treating Duchenne. We are excited to have generated
two novel drug candidates, SAT-3247 and SAT-3153, to serve as lead
and back-up development candidates, respectively.”
Mr. Gleeson continued, “We are also pleased to welcome a
clinical development professional of Courtney’s stature and
experience who chose to join Satellos and lead the execution of our
clinical development plan for SAT-3247 at this critical junction in
our evolution to becoming a clinical stage company in 2024.”
Preclinical data generated by Satellos has demonstrated that
SAT-3153 and SAT-3247 have a similar capacity to affect stem cell
polarity, enhance muscle regeneration, and improve muscle force in
the mdx mouse model of Duchenne. SAT-3247 also exhibited improved
oral bioavailability, target specificity, and tissue distribution,
when compared directly to SAT-3153. Based on this data, the Company
will prioritize SAT-3247 as its lead development candidate to
advance into clinical trials with SAT-3153 becoming its back-up
candidate. Both small molecule candidates as well as the discovery
that AAK1 can be modulated to enable muscle regeneration are
covered by patent applications filed by the Company.
“The data in our Duchenne program continue to support our drug
target, mechanism of action, and proprietary small molecule leads,”
said Phil Lambert, Ph.D., Chief Scientific Officer of Satellos. “In
addition, previously published external clinical programs with AAK1
inhibitors have demonstrated the ability to safely inhibit this
target, which further encourages us in our development plans. With
our team’s expertise, we have created small molecules that are
selective for and effective at inhibiting AAK1 to modulate muscle
stem cell polarity leading to the repair and regeneration of
functional muscle tissue in our preclinical models. We are excited
about the improved oral bioavailability, target selectivity, and
tissue distribution that SAT-3247 has exhibited in these models. We
look forward to expeditiously completing our ongoing IND-enabling
studies and GMP manufacturing and moving into clinical trials.”
Alan Jacobs, M.D. FAAN, Chief Medical Officer of Satellos,
added, “I am pleased to welcome Courtney to the Satellos team as
Senior Vice President of Clinical Development Operations to lead
and implement our clinical trial plans. With more than 20 years of
experience in clinical development operations for large
pharmaceutical companies and innovative biotech companies,
including orphan diseases and Duchenne, we believe her addition is
timely and that her expertise will be invaluable in leading and
advancing SAT-3247 through clinical development, which we plan to
initiate in mid-2024.”
About Muscle Progenitor Cells and Duchenne Muscular
Dystrophy
Duchenne patients suffer from an inability to regenerate, grow,
and repair muscle. Muscle tissue is regenerated through asymmetric
division of muscle stem cells into stem and progenitor cells.
Duchenne patients have abundant muscle stem cells, but lack muscle
progenitor cells, which leads to a defect in muscle tissue
regeneration and results in progressive muscle loss. Satellos
scientific founder, Dr. Michael Rudnicki, discovered and has
demonstrated how dystrophin is present in muscle stem cells and
coordinates a biological process known as “stem cell polarity” to
regulate asymmetric cell division. Furthermore, in the absence of
dystrophin, the ability to generate progenitor cells is lost, which
the Company believes is the underlying cause of Duchene. For the
Company’s Duchenne program, Satellos has designed small molecules
to inhibit AAK1, a protein kinase member of the Notch pathway. The
Company believes AAK1 inhibition, independent of dystrophin, has
the capacity to regulate polarity to restore asymmetric muscle stem
cell division, generate muscle progenitor cells, and enable muscle
regeneration.
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 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 general benefits of modulating stem cell polarity
by administering small molecule drugs; its/their prospective impact
on Duchenne patients and 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 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, and those risks listed in the “Risk Factors”
section of Satellos’ prospectus dated May 9, 2023 and Satellos’
Annual Information Form dated April 27, 2023 (both of which are 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.
No regulatory authority has approved or disapproved the
content of this press release. Neither the TSX Venture Exchange nor
its Regulatory Services Provider (as that term is defined in the
policies of the TSX Venture Exchange) accepts responsibility for
the adequacy or accuracy of this press release.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231114699220/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 (TSXV:MSCL)
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