SOUTH SAN FRANCISCO, Calif. — Epicrispr Biotechnologies has announced a new partnership with Springbok Analytics to incorporate advanced AI-powered muscle MRI analysis into its first-in-human clinical trial for EPI-321, an investigational therapy for facioscapulohumeral muscular dystrophy (FSHD). The trial marks the first clinical application of epigenetic gene modulation in a neuromuscular disease.
The global trial, recently cleared to begin in the United States and New Zealand, will evaluate the safety, tolerability, and biological activity of a single intravenous dose of EPI-321 in adults with FSHD. Additional regulatory approvals are pending in other countries. As part of the collaboration, Springbok’s muscle imaging platform will provide high-resolution, quantitative insights into muscle-level changes—data that could play a critical role in shaping the development of this first-in-class treatment.
Amber Salzman, Ph.D., CEO of Epicrispr, emphasized the importance of early, objective data in developing new therapies. “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,” she said.
Springbok’s proprietary technology uses artificial intelligence to segment and analyze dozens of individual muscles from MRI scans, delivering rapid assessments of biomarkers such as muscle volume, fat infiltration, and inflammation. These analytics are designed to streamline data interpretation, offering actionable insights within hours and supporting more informed decisions during the early phases of clinical development.
Although MRI is being used as an exploratory biomarker in the EPI-321 trial rather than a primary endpoint, the ability to detect subtle changes in muscle composition could help researchers identify early biological responses that conventional clinical measures may miss. This is especially important in diseases like FSHD, where traditional functional endpoints may take longer to reflect therapeutic impact.
“Quantitative imaging has the potential to dramatically enhance data collection in early-stage neuromuscular trials,” said Scott Magargee, CEO and Co-Founder of Springbok Analytics. “We’re proud to support Epicrispr as it pioneers a new therapeutic approach for FSHD and advances the role of imaging biomarkers in clinical development.”
Springbok’s contributions to the study include streamlined whole-body MRI protocols capable of capturing detailed muscle data in under 45 minutes, high-resolution analytics for muscle assessment, and scalable infrastructure to support global clinical sites.
Epicrispr’s development of EPI-321 is backed by a $68 million Series B funding round led by Ally Bridge Group and SOLVE FSHD. Data from this trial is expected to inform imaging biomarkers for future studies and support regulatory discussions as the company progresses toward later-stage development.
