Epicrispr & Springbok Partner on AI Muscle Analysis for First FSHD Human Study
Epicrispr Biotechnologies, a company dedicated to developing curative gene-modulating therapies, has announced a strategic partnership with Springbok Analytics. The collaboration will integrate advanced AI-based muscle MRI imaging and analysis into Epicrispr’s first-in-human clinical trial of EPI-321—a promising, first-in-class treatment candidate for facioscapulohumeral muscular dystrophy (FSHD).
The global exploratory trial of EPI-321, recently cleared to begin in the United States and New Zealand, aims to evaluate the safety, tolerability, and biological activity of a single intravenous dose in adults with FSHD. Regulatory submissions are also underway in additional countries. As part of the study, Springbok Analytics will provide its cutting-edge muscle imaging technology to gather precise, early insights into how EPI-321 affects muscle tissue.
High-Resolution Insights from Day One
“High-quality, objective data is essential in early clinical development, especially when advancing a first-in-class therapeutic,” said Amber Salzman, Ph.D., CEO of 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 AI platform is designed to analyze muscle-level MRI data with exceptional granularity. Using advanced algorithms, the technology can automatically segment and quantify dozens of individual muscles from MRI scans. It assesses critical biomarkers including muscle volume, fat infiltration, and inflammation—metrics that are highly relevant in the progression and treatment of neuromuscular diseases like FSHD.
Unlike conventional functional assessments, which may take months or years to reveal therapeutic effects, quantitative muscle imaging offers a faster, more sensitive method to evaluate biological response in the early stages of drug development. This capability is especially valuable in a first-in-human trial like this one, where researchers are exploring uncharted territory in terms of treatment effect and biological markers.
Accelerating Insight with AI-Powered Imaging
While MRI-based biomarkers are considered exploratory in this Phase 1 study and are not formal endpoints, they play a pivotal role in guiding future clinical development. Early detection of subtle changes in muscle health may significantly inform dose selection, trial design, and regulatory strategy.
“Quantitative imaging has the potential to dramatically capture more information in early-stage trials in neuromuscular disease,” said Scott Magargee, CEO and Co-Founder of 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: Whole-body MRI protocols that allow efficient data collection in under 45 minutes, reducing patient burden while maintaining data quality.
- Advanced Analytics: Automated segmentation and analysis of muscle groups, generating high-resolution insights into muscle composition and pathology across the entire body.
- Scalable Support Infrastructure: A robust quality management system and turnkey onboarding process to facilitate smooth implementation across global study sites.
A New Chapter in FSHD Research
EPI-321 represents the first clinical application of epigenetic gene modulation in a neuromuscular disease. Epicrispr’s proprietary Gene Expression Modulation System (GEMS) is designed to enable precise, durable control of gene expression. In the case of FSHD, this approach offers a potentially transformative option for patients suffering from a condition that currently lacks approved disease-modifying treatments.
Epicrispr is advancing EPI-321 with the backing of a $68 million Series B financing round, co-led by Ally Bridge Group and SOLVE FSHD. The funds are supporting both the clinical trial and the development of imaging biomarkers that could serve as valuable tools for future phases and regulatory engagement.
About the Companies
Epicrispr Biotechnologies
Epicrispr is a biotechnology company pioneering gene-modulating therapies, starting with treatments for neuromuscular diseases. Its GEMS platform allows precise, long-lasting control over gene expression, creating opportunities for first-in-class therapies for previously untreatable conditions. Epicrispr’s lead candidate, EPI-321, is currently in clinical trials for FSHD. The company also maintains a research partnership with Kite Pharma focused on next-generation CAR T-cell therapies.
Springbok Analytics
Springbok Analytics leverages artificial intelligence and advanced MRI analysis to deliver high-resolution muscle insights. Its proprietary technology enables fast, accurate assessments of muscle health, volume, and pathology, making it an ideal partner for clinical trials in musculoskeletal and neuromuscular disorders.
Together, Epicrispr and Springbok are charting a new path forward in FSHD research—using next-generation imaging to support next-generation therapies.
