Komodo Health’s Real-World Evidence and Technology Platform Powers Two Real-World Analyses in Primary Biliary Cholangitis for Intercept Pharmaceuticals

Rhea-AI Summary

Komodo Health announced a collaboration with Intercept Pharmaceuticals (NASDAQ: ICPT) to enhance clinical research using Komodo's platform. This partnership enabled a retrospective study on long-term outcomes for Ocaliva, a treatment for primary biliary cholangitis (PBC). The study demonstrated significant improvement in event-free survival for patients treated with Ocaliva. Despite previous challenges with a placebo-controlled study, this new approach leverages real-world evidence to validate treatment effectiveness, supported by the FDA's recent guidance on real-world data usage in regulatory submissions.

Positive

• Collaboration with Intercept Pharmaceuticals to enhance clinical research.
• Successful retrospective study showing significant improvement in event-free survival for Ocaliva-treated patients.

Negative

• Previous termination of the placebo-controlled clinical outcomes study due to feasibility challenges.

SAN FRANCISCO--(BUSINESS WIRE)-- Today, Komodo Health announced a collaboration with Intercept Pharmaceuticals (Nasdaq: ICPT), powering clinical research and new real-world evidence with Komodo’s platform. Intercept leveraged Komodo’s technology to fuel a retrospective study on long-term outcomes for Ocaliva, a therapeutic to treat primary biliary cholangitis (PBC), a rare liver disease. Results of the study focused on the real-world impact of Ocaliva and were announced last week at the American Association for the Study of Liver Diseases (AASLD).

Intercept initially developed a placebo-controlled clinical outcomes study, COBALT, to evaluate patients with advanced PBC using Ocaliva, but terminated it due to feasibility challenges. Recognizing these challenges, Intercept initiated several real-world evidence studies including a retrospective observational study, HEROES-US, by linking data from Komodo’s Healthcare Map with other key data sources using Sentinel. Researchers compared clinical outcomes in a pre-defined group of patients with PBC who were treated with Ocaliva to outcomes for a comparable group of PBC patients who were eligible, but who were not treated with Ocaliva. This real-world analysis ultimately demonstrated statistically significant improvement in event-free survival for PBC patients receiving Ocaliva.

As real-world data sources continue to proliferate, the biomedical community is increasingly turning toward that data as a reliable, powerful source of evidence to understand the safety and effectiveness of medical therapies in a real-world setting.

Arif Nathoo, Komodo Health Co-Founder and Chief Executive Officer, said: "Komodo launched Sentinel to enable real-world evidence at scale. Intercept’s HEROES study embodies our view of the future, one that is based on using real-time patient insights to improve patient outcomes. These kinds of important studies, which link Komodo's Healthcare Map to labs, demographics, and multiple other data sources, are finally unlocking an insight-driven transformation across the industry."

In September, the FDA issued additional guidance for the Life Sciences industry on the use of RWE in regulatory submissions, and ongoing regulatory guidance continues to create more structure around the definitions and applications of RWE. Based on the FDA’s guidance around data sources, standards, and processes, the size and completeness of Komodo’s foundational data asset is uniquely positioned to drive regulatory-grade insights for Life Sciences and other healthcare entities pursuing real-world research.

Komodo already has a proven track record of providing research-grade RWE insights to academic institutions, providing the data-driven tools for high-fidelity HEOR studies, and powering synthetic control arms in clinical trials to ensure studies are reflective of the entire patient population.

About Komodo Health
Komodo Health is a technology platform company creating the new standard for real-world data and analytics by pairing the industry’s most complete view of patient encounters with enterprise software and machine learning that connects the dots between individual patient journeys and large-scale health outcomes. Across Life Sciences, payer, provider, and developers, we help our customers unearth patient-centric insights at scale — marrying clinical data with advanced algorithms and AI-powered software solutions to inform decision making, close gaps in care, address disease burden, and help the enterprise create a more cost-effective, value-driven healthcare system. For more information, visit komodohealth.com.

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media@komodohealth.com

Source: Komodo Health

FAQ

What is the collaboration between Intercept Pharmaceuticals and Komodo Health about?

The collaboration focuses on using Komodo's platform to enhance clinical research and real-world evidence for Intercept's Ocaliva treatment.

What were the results of the study on Ocaliva conducted by Intercept Pharmaceuticals?

The study demonstrated statistically significant improvement in event-free survival for patients treated with Ocaliva.

Why was the COBALT study on Ocaliva terminated?

The COBALT study was terminated due to feasibility challenges.

How does Komodo Health's platform contribute to real-world evidence studies?

Komodo's platform links multiple data sources to provide insights into the safety and effectiveness of treatments in real-world settings.

What recent FDA guidance affects the use of real-world evidence in clinical studies?

The FDA issued guidance for the Life Sciences industry on the use of real-world evidence in regulatory submissions.