Partnering with Odyssey Therapeutics to Transform Ulcerative Colitis Treatment

We’re excited to share our partnership with Odyssey Therapeutics, a biotechnology company pioneering a new standard of care for autoimmune and inflammatory diseases. With a pipeline built on precision immunology and a differentiated approach targeting upstream signaling in the innate immune system, Odyssey is redefining what’s possible in inflammatory bowel disease (IBD) treatment.

At Miracle, we’re honored to support Odyssey’s Phase 2a clinical trial evaluating OD-07656, an oral RIPK2 scaffolding inhibitor, as a first-in-class therapy for patients with moderately to severely active UC. This novel approach not only targets inflammation at its source, but also has potential to be combined with other drugs to break the therapeutic ceiling of efficacy observed with existing standard of care. Miracle is serving as the single pane of glass unifying information from across various clinical trial systems like Electronic Data Capture (EDC), Interactive Response Technology (IRT), and central to automate reporting, identify risks, accelerate trial execution and support this ambitious clinical program.

‍

‍The Challenge: Running an Innovative, Sequential Trial in a Complex Indication

Odyssey’s UC study is designed in two parts to address two questions: first, induction efficacy of monotherapy OD-07656, and second, can OD-07656 reset the immune response to improve efficacy of sequential standard of care treatment with vedolizumab. The protocol requires careful coordination across timelines, endpoints, and clinical trial systems, including EDC, IRT, and central labs.

With multiple systems tracking enrollment, dosing, labs, and safety events, the Odyssey team needed a unified, automated solution to maintain real-time visibility and ensure all stakeholders could align and access actionable insights quickly, ranging from medical and safety teams to clinical operations and senior leadership.

Key challenges included:

• Fragmented Trial Data across multiple systems, slowing decision-making and increasing the risk of oversight.
• Manual Data Aggregation and reporting workflows, pulling time away from strategic analysis and decision-making.
• Visibility Gaps across enrollment milestones, visit schedules, safety monitoring, and lab data.

To fully execute their data-driven vision, Odyssey needed a platform that could integrate all systems, centralize insights, and support proactive decision-making at scale.

‍Enter Miracle: Real-Time Insights for Trial Success

With Miracle’s out-of-the-box integrations, Odyssey was live with automated dashboards in days. From the start, we delivered immediate visibility into enrollment progress, safety, eligibility review, lab trends, and more.

Miracle’s platform enabled Odyssey to:

• Track Enrollment in Near Real Time: View screenings, randomizations, dropouts, and completion rates by site and cohort.
• Assess Efficacy & Safety: Monitor primary and secondary efficacy endpoints with ease and tracking of lab values, safety, and tolerability at the patient level.
• Forecast Study Timelines: Predict enrollment curves and site performance to stay on track.
• Monitor Lab Results & Medical Metrics: Identify trends, outliers, and signals at the subject and study level, in addition to implementing alerts to support robust real-time safety monitoring across all participants.
• Enable Cross-Team Collaboration: Provide tailored dashboards to medical, safety, clinical operations, data management, and leadership, aligning everyone around the same real-time data.

With our intuitive, self-serve analytics tools, Odyssey teams can now move from data gathering to data interpretation, freeing up time and enabling faster, better decisions across the board.

‍

‍Looking Ahead

Odyssey Therapeutics is setting a new bar for autoimmune disease drug development by addressing the root cause of inflammatory dysregulation. We’re thrilled to support their vision and provide the infrastructure to accelerate their clinical programs. Know someone with ulcerative colitis seeking a new treatment option who has interest in being part of a clinical trial?

To learn more, please reach out to clinicaltrials@odysseytx.com.                                                                    

About Miracle

Miracle is redefining clinical trial management by serving as the control room for clinical trials. Our platform integrates data from multiple clinical systems into one portal, offering real-time automated insights that reduce manual workflows, drive operational efficiency, and save time in clinical trials.

For more information, visit our website or contact us at sales@miracleml.com.