- Marks successful completion of full enrollment of SAD cohorts and the first two MAD cohorts in the healthy volunteer study
- Up to 10 adult participants with genetically confirmed Duchenne Muscular Dystrophy ("DMD") to be enrolled in the now ongoing Phase 1b trial in DMD patients
- Phase 1 data to be presented at major medical conference in Q1 2025
TORONTO, December 11, 2024--(BUSINESS WIRE)--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, announced today that the first participant with Duchenne muscular dystrophy ("DMD") has been dosed in the Phase 1b safety and pharmacokinetics ("PK") trial in DMD patients.
"The dosing of our first DMD participant is a major milestone in evaluating SAT-3247’s potential benefit for DMD patients," said Frank Gleeson, Satellos Co-founder and CEO. "We are very pleased to have safely completed the full enrollment and dosing of all five cohorts in the single ascending dose ("SAD") study and the first two multiple ascending dose ("MAD") cohorts. This reinforces our view that SAT-3247 has potential to be a safe and tolerable, once-daily, oral treatment option for DMD patients. We look forward to continuing to advance SAT-3247 as a potential disease modifying therapy for degenerative muscle conditions."
Satellos expects to enroll up to 10 adult participants with genetically confirmed DMD in a 28-day, open-label, single dose cohort to assess safety and PK properties in patients and explore potential pharmacodynamic markers.
Clinical data results to date:
Healthy volunteers dosed with SAT-3247 in the SAD cohorts of the study and the first cohort of the MAD did not experience any adverse side effects and the drug was well tolerated. Safety findings include:
No drug-related adverse events reported
No abnormal findings on clinical labs
No abnormal findings on vitals
No abnormal findings on ECG
No abnormal findings on physical exams
In addition, the PK profile of SAT-3247 in healthy volunteers translated effectively from pre-clinical models into human subjects.
About the Phase 1 DMD Trial
The Phase 1 clinical trial is comprised of two components. In the first component, 72 healthy adult volunteers are being enrolled in a blinded, randomized, placebo-controlled study to assess the safety and pharmacokinetic properties of SAT-3247. Volunteers are 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 and up to 10 adult participants 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 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 initially in Duchenne muscular dystrophy (DMD). Satellos has generated a significant body of preclinical evidence in DMD to support its discovery that correcting muscle stem cell polarity with SAT-3247 has the potential to restore skeletal muscle regeneration to repair and strengthen muscle that has been damaged. The Company’s lead drug candidate, SAT-3247, is currently in clinical development as a potential disease-modifying treatment for DMD. Additionally, Satellos is leveraging its breakthrough research and proprietary discovery platform MyoReGenX™, to identify degenerative muscle diseases 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; the expectations regarding enrollment in the Company's 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 into 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
