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Satellos Announces Promising Preliminary Data in Facioscapulohumeral Muscular Dystrophy

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Satellos Bioscience Inc. announces positive preliminary data for SAT-3247 in treating degenerative muscle diseases. The company is set to start clinical trials for Duchenne muscular dystrophy in mid-2024.
Positive
  • Positive preliminary data for SAT-3247 in improving skeletal muscle function in FSHD mouse model
  • Plans to initiate first-in-human clinical trial for Duchenne muscular dystrophy in mid-2024
  • Potential of SAT-3247 to improve muscle regeneration in degenerative muscle diseases
  • Successful improvement in phenotype of FSHD mice with SAT-3247 treatment
  • SAT-3247 designed to inhibit AAK1, a protein kinase member of the Notch pathway
Negative
  • None.
  • Data support potential for SAT-3247 in multiple degenerative muscle diseases
  • On track to initiate first-in-human clinical trial mid-2024 for Duchenne muscular dystrophy

TORONTO--(BUSINESS WIRE)-- Satellos Bioscience Inc. (“Satellos” or the “Company”) (TSXV: MSCL) (OTCQB: MSCLF), a public biotech company developing new small molecule therapeutic approaches to improve the treatment of muscle diseases and disorders, announced today positive preliminary data showing SAT-3247 can improve skeletal muscle function in a mouse model of facioscapulohumeral muscular dystrophy (FSHD).

Frank Gleeson, Cofounder and CEO of Satellos, said, “These data in FSHD, in combination with our preclinical Duchenne studies, collectively demonstrate the impact of SAT-3247 on improving muscle regeneration in degenerative muscle diseases. We look forward to presenting these data at the MDA Clinical and Scientific Conference 2024 and advancing SAT-3247 into clinical trials for Duchenne muscular dystrophy mid-year.”

Neil Camarta, Co-Founder and CEO of the FSHD Canada Foundation, said “I’m very pleased. It’s early days, but these results provide hope for FSHD patients. I’m looking forward to working with Satellos to accelerate the development of this promising drug candidate, because time is muscle!”

FSHD is the third most common muscular dystrophy behind Duchenne (& Beckers) and myotonic dystrophy. FSHD is an adult onset muscular dystrophy that results in the progressive destruction of muscle tissue, owed to the erroneous expression of a gene product called DUX4. Most treatments in development for FSHD are focused on trying to block the expression of DUX4.

In research conducted under a grant from the FSHD Canada Foundation, Satellos tested whether treating with SAT-3247 could counter the progressive destruction of muscle tissue seen in FSHD. Satellos demonstrated that treatment with SAT-3247 successfully improved the phenotype of FSHD mice, which was observed as a significant impact on improving skeletal muscle function.

Satellos’s SAT-3247 is a small molecule designed 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, our ability to initiate clinical studies in mid-2024, our ability to accelerate development plans,, statements regarding the anticipated benefits to patients from a small molecule treatment for Duchenne or other indications; 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, 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.

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

Source: Satellos Bioscience Inc.

FAQ

What is the significance of the preliminary data announced by Satellos Bioscience Inc. regarding SAT-3247?

The preliminary data shows that SAT-3247 can improve skeletal muscle function in a mouse model of FSHD, indicating its potential in treating degenerative muscle diseases.

When is Satellos Bioscience Inc. planning to start the first-in-human clinical trial for Duchenne muscular dystrophy?

Satellos is on track to initiate the first-in-human clinical trial for Duchenne muscular dystrophy in mid-2024.

What is the mechanism of action of SAT-3247 in improving muscle regeneration?

SAT-3247 is designed to inhibit AAK1, a protein kinase member of the Notch pathway, which has the capacity to regulate polarity to restore asymmetric muscle stem cell division, generate muscle progenitor cells, and enable muscle regeneration.

What is the focus of most treatments in development for FSHD?

Most treatments in development for FSHD are focused on trying to block the expression of DUX4, a gene product responsible for the progressive destruction of muscle tissue in FSHD.

What positive impact did SAT-3247 treatment have on FSHD mice?

Treatment with SAT-3247 successfully improved the phenotype of FSHD mice, showing a significant impact on improving skeletal muscle function.

SATELLOS BIOSCIENCE INC

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