Sanofi is set to trial an artificial intelligence (AI)-based tool named Muse to accelerate patient recruitment for its Phase 3 clinical trials in multiple sclerosis (MS). Developed in collaboration with Formation Bio and OpenAI, Muse aims to streamline the often slow and expensive process of clinical trial enrollment.
Patient recruitment challenges frequently delay trial completion, impacting the availability of new treatments. Less than 10% of patients participate in clinical trials, highlighting the need for innovative solutions.
How Muse Works
Muse leverages AI to develop recruitment strategies and generate targeted materials for diverse populations. It conducts extensive analysis of scientific literature, patient data, and existing therapies to define the optimal patient profile for a given study. This enables the creation of recruitment strategies tailored to include those patients.
The AI tool can also automatically generate recruitment materials and pre-screening questionnaires to reach specific patient subgroups, potentially improving representation of historically under-represented groups and diversifying patient populations in clinical trials.
Integration with Regulatory Guidelines
Muse incorporates a large language model (LLM) agent designed to adhere to institutional review board and regulatory guidelines. This feature aims to reduce the risk of regulatory setbacks and promote smoother trial progression.
According to a press release by Formation Bio, the LLM feature, combined with human expertise, ensures compliance and efficiency in trial progression.
Sanofi's MS Therapies
Sanofi is currently developing two therapies for MS: frexalimab and tolebrutinib. While the press release did not specify which therapy would be tested using Muse, the company aims to enhance recruitment efficiency and expedite the delivery of new medicines to patients.
Emmanuel Frenehard, Sanofi’s chief digital officer, stated that Muse represents a step towards Sanofi becoming the first pharma company powered by AI at scale. Ben Liu, PhD, Formation Bio’s co-founder and CEO, emphasized AI's potential to transform drug development, enhancing both efficiency and outcomes.
