WALTHAM, Mass.–(BUSINESS WIRE)–Dyne Therapeutics, a biotechnology company pioneering targeted therapies for patients with serious muscle diseases, today announced its support for the ReSolve study, an ongoing natural history study designed to inform the development of therapies for facioscapulohumeral muscular dystrophy (FSHD). ReSolve (Clinical Trial Readiness to Solve Barriers to Drug Development in FSHD) is an observational study run by the FSHD Clinical Trial Research Network (CTRN), a network of medical centers across the U.S. and Europe that aims to validate new clinical outcome assessments and refine trial planning strategies in FSHD.
“Dyne is working to deliver life-changing therapies to patients with serious muscle diseases, including FSHD, by leveraging our muscle-targeted FORCE™ platform technology,” said Romesh Subramanian, Ph.D., president and chief executive officer of Dyne. “We are proud to contribute to initiatives like the ReSolve study that seek to accelerate the development of new therapeutic options.”
The 18-month, longitudinal ReSolve study is enrolling approximately 160 patients with FSHD across eight sites in the U.S., plus an additional 60 patients across three sites in Europe. The specific goals of the study are to validate new clinical outcome assessments and evaluate physiological biomarkers to support the design and implementation of future clinical trials.
To date, approximately 140 patients have been enrolled in the study. Funding from Dyne will lead to an expansion of the number of sites and participants in Europe, as well as fund a muscle biopsy study to advance biomarker development. In addition to Dyne, supporters of the ReSolve study and the CTRN include the National Institutes of Health, Muscular Dystrophy Association, FSHD Society, AFM, Fulcrum Therapeutics and Friends of FSH Research.
“With the advancement of targeted treatments for FSHD, it is now more critical than ever to develop reliable clinical outcome assessments and methodologies,” said Dr. Jeffrey Statland, M.D., co-principal investigator of the ReSolve study. “We are grateful for Dyne’s support and look forward to working with them to advance this important work.”
For more information about the ReSolve study, including eligibility criteria and a full list of study locations and contacts, please visit clinicaltrials.gov.
About Dyne Therapeutics
Dyne Therapeutics is pioneering therapies that target muscle tissue with unprecedented precision to restore muscle health. The company’s FORCE™ platform delivers oligonucleotides and other molecules to skeletal, cardiac and smooth muscle to treat a range of serious muscle diseases. Dyne is advancing a treatment for myotonic dystrophy type 1 (DM1) in addition to programs for Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Dyne launched in 2019 and is based in Waltham, Mass. For more information, please visit www.dyne-tx.com.
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