- Advanced MRI analytics to enhance early signal detection and inform development of first-in-class epigenetic therapy

SOUTH SAN FRANCISCO, Calif.: #FSHD--Epicrispr Biotechnologies, a biotechnology company focused on developing curative therapies, today announced a partnership with Springbok Analytics to incorporate advanced, AI-driven muscle MRI imaging and analysis into its first-in-human clinical trial of EPI-321, a potential first-in-class treatment for facioscapulohumeral muscular dystrophy (FSHD).

The exploratory first-in-human global trial, recently cleared to begin in the United States and New Zealand, with additional regulatory approvals pending in other countries, is designed to evaluate the safety, tolerability, and biological activity of a single intravenous dose of EPI-321 in adults with FSHD. Through this collaboration, Springbok’s advanced MRI-based muscle analytics will be integrated into the study to detect early, objective insights of muscle-level changes and generate high-resolution data.

“High-quality, objective data is essential in early clinical development, especially when advancing a first-in-class therapeutic,” said Amber Salzman, Ph.D., CEO, Epicrispr Biotechnologies. “Springbok’s automated muscle analysis gives us a detailed view of how EPI-321 may be impacting muscle tissue, strengthening our ability to assess early signals and shape future development.”

Springbok’s proprietary technology uses proprietary AI to segment and quantify dozens of individual muscles from MRI scans, analyzing key biomarkers such as muscle volume, fat infiltration, and inflammation. These high-resolution analytics allow for rapid interpretation of complex imaging data to deliver actionable insights within hours and supporting data-driven clinical decisions from the earliest stages of development.

While MRI is an exploratory biomarker in this first-in-human trial, and not a primary study endpoint, the ability to detect subtle, muscle-level changes may be critical in shaping the design of future studies. In conditions like FSHD, where conventional functional endpoints may take longer to reflect therapeutic effect, quantitative muscle imaging offers an accelerated path to understanding biological response.

“Quantitative imaging has the potential to dramatically capture more information in early-stage trials in neuromuscular disease,” said Scott Magargee, CEO and Co-Founder, Springbok Analytics. “We’re proud to support Epicrispr as it pioneers a new therapeutic modality for FSHD and advances the role of imaging biomarkers in clinical development.”

Springbok’s Contributions to the EPI-321 Study Include:

• Streamlined Imaging Protocols: Enabling whole-body MRI to assess muscle volume and fat infiltration in under 45 minutes.
• High-Resolution Analytics: Automated segmentation and quantification of muscle volume, fat content, and inflammation across dozens of muscle groups.
• Scalability & Support: A robust quality management system and turnkey onboarding processes to support rapid deployment across global study locations.

Epicrispr is advancing EPI-321 with support from a $68 million Series B financing led by Ally Bridge Group and SOLVE FSHD. EPI-321 is the first clinical application of epigenetic gene modulation in neuromuscular disease, and data generated through this study will help define imaging biomarkers for later-phase trials and support regulatory engagement.

About Epicrispr Biotechnologies

Epicrispr Biotechnologies is a biotechnology company pioneering gene-modulating therapies, leading with treatments for neuromuscular diseases. The company’s proprietary Gene Expression Modulation System (GEMS) enables precise, durable control of gene expression, unlocking first-in-class treatments for previously untreatable conditions. Epicrispr’s lead program, EPI-321 is in clinical trials for FSHD, and the company is advancing additional gene-modulating therapies. Epicrispr also has a research collaboration with Kite Pharma to develop next-generation CAR T-cell therapies. Learn more at www.epicrispr.com or follow us on LinkedIn.

About Springbok Analytics

Springbok Analytics is a leading muscle health analytics company dedicated to advancing health and performance outcomes through innovative, AI-driven solutions that deliver a clearer, more comprehensive view of muscle health.

Built on more than 15 years of research and scientific validation, Springbok's FDA-cleared technology transforms MRI data into personalized, 3D visualizations of muscle health. These detailed analyses provide precise metrics, including individual muscle volume and composition, fat infiltration, asymmetries, scar tissue, edema, and tendon morphology. By offering a more accurate and complete understanding of musculoskeletal health, Springbok enhances diagnostic accuracy, treatment monitoring, research capabilities, and performance optimization.

Fonte: Business Wire