Satellos Completes Enrollment for Phase 1 SAT-3247 Trial in Healthy Volunteers
Satellos Bioscience Inc. (TSX: MSCL, OTCQB: MSCLF), a biotech company focused on developing small molecule therapies to treat muscle diseases, has announced the completion of enrollment for all four multiple-ascending dose (MAD) cohorts in its Phase 1 clinical trial of SAT-3247 in healthy volunteers. This marks a key milestone for the company as it progresses towards developing therapies for patients with degenerative muscle conditions, including Duchenne muscular dystrophy (DMD).
Frank Gleeson, Co-founder and CEO of Satellos, commented, “The completion of healthy volunteer enrollment in our Phase 1 trial is a significant achievement in our mission to create transformative therapies for degenerative diseases. We believe SAT-3247 represents a novel and well-tolerated treatment, offering a more favorable option as an oral, once-daily therapy designed to restore muscle regeneration and repair in DMD patients. This progress positions us to present the first Phase 1 data at an upcoming major medical conference and further supports our commitment to providing meaningful solutions to the DMD community.”
About the Phase 1 DMD Trial
The Phase 1 clinical trial is designed in two parts. The first part consists of a blinded, randomized, placebo-controlled, staggered, parallel design study involving 72 healthy volunteers. These participants were randomized across five single-ascending dose (SAD) cohorts, four multiple-ascending dose (MAD) cohorts, and one food effect dose cohort. This component is aimed at assessing the safety and pharmacokinetic properties of SAT-3247.
The second part of the trial, the Phase 1b portion, is currently ongoing. It will enroll up to 10 adult volunteers with genetically confirmed DMD, who will participate in a 28-day, open-label, single-dose cohort. This part of the trial is focused on evaluating safety and pharmacokinetics in DMD patients, while also exploring potential pharmacodynamic markers that may provide insights into how SAT-3247 impacts muscle regeneration.
About SAT-3247
SAT-3247 is a proprietary oral small molecule drug developed by Satellos to target muscle regeneration. It is being evaluated as a novel treatment for Duchenne muscular dystrophy (DMD) and other degenerative muscle conditions. The drug works by restoring the function of muscle stem cells, which are essential for skeletal muscle repair and regeneration. Importantly, SAT-3247 is being developed as a potential treatment for DMD regardless of the patient’s dystrophin status or exon mutation, which are typically key factors in DMD therapies.
SAT-3247 aims to regenerate muscle tissue that is lost due to degenerative conditions like DMD. The drug is designed to help repair and strengthen muscle, independent of dystrophin, providing a potential treatment option for a broader range of patients. The therapy could be used as a stand-alone treatment or as an add-on to existing therapies, offering more flexibility and potential for better patient outcomes.
Satellos Bioscience Inc.
Satellos is a clinical-stage drug development company focused on creating life-improving therapies for degenerative muscle diseases. The company’s lead product, SAT-3247, is a first-of-its-kind, orally administered small molecule drug designed to restore muscle regeneration in conditions where muscle loss occurs, such as DMD and other injuries or degenerative diseases.
Satellos has accumulated extensive preclinical evidence supporting SAT-3247’s ability to correct muscle stem cell polarity, a key process involved in muscle regeneration. By restoring this polarity, SAT-3247 has the potential to repair and strengthen muscle that has degenerated or been damaged. This innovative approach could significantly impact the treatment of DMD and other conditions involving muscle degeneration.
In addition to DMD, Satellos is exploring the use of SAT-3247 for other muscle degenerative diseases. The company leverages its proprietary discovery platform, MyoReGenX™, to identify additional conditions where muscle regeneration deficits occur and where SAT-3247 could provide therapeutic benefit. Satellos is dedicated to advancing clinical development to help improve the lives of patients suffering from muscle diseases and disorders, with the ultimate goal of creating disease-modifying treatments.
