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We spoke with OMNI-BD scientists about OMNI-BD’s involvement in the COVASTIL study and the work they have been doing in the COVID-19 space.
COVASTIL is a randomized, placebo-controlled Phase 2 clinical trial that evaluates the safety and efficacy of the two of our Phase 2drugs, anti-ST2 (MSTT1041A) and IL-22Fc (UTTR1147A) in approximately 300 patients hospitalized with severe COVID-19 pneumonia. Both drugs may prevent COVID-19 pneumonia progression to Acute Respiratory Distress Syndrome (ARDS) and/or promote recovery of patients with ARDS. ST2 is the receptor for IL-33 (an epithelial ‘alarmin’ released upon damage/virus infection), and inhibition of IL-33 signaling is predicted to reduce maladaptive hyperinflammatory responses. IL-22 is a cytokine that can promote epithelial and endothelial cell repair in the lung and induces anti-microbial peptides that may protect against secondary bacterial infections without compromising antiviral host defense. COVASTIL achieved FPI on June 2 with expected study readout at the end of 2020.
A unique challenge with COVASTIL was studying two molecules with independent MOAs in one trial. However, this has been an opportunity to take learnings from past/ongoing molecule trials and brought together individual Biomarker Subteam Leaders (BMSTLs) from anti-ST2 and IL-22Fc to co-lead the COVASTIL biomarker effort. Because this is a fragile patient population and study is being run during a pandemic, biomarker strategies were streamlined to balance patient burden and collection of samples to ensure we have the right data to answer key biomarker questions for this program and both drugs as well as to inform development and research efforts. The COVASTIL team was lucky to leverage all the work and learnings from the Actemra COVID teams who were one step ahead in this process and provided crucial guidance. The collective efforts of the entire COVASTIL team and many across gRED enabled this team to go from kick-off to IND filing in under two weeks!
The OMNI Biomarker Development organization is currently supporting three molecules across four COVID-19 trials: COVACTA, MARIPOSA, COVASTIL and REMDACTA. While each program has a targeted biomarker strategy and team lead, these efforts are intertwined with opportunities for synergy and sharing of data and insights.
A primary focus is to ensure that the biomarker teams deliver data to help answer these key questions facing the COVID-19 teams:
Who is the right patient?
What is the right dose?
When is the right time?
How does the drug work in COVID-19?
What are the longer term outcomes of COVID-19?
Therefore, OMNI-BD kicked-off a cross-functional COVID-19 Disease Area Biomarker Subteam (BMST) that, in addition to supporting project-related biomarker strategies, will focus on understanding disease level heterogeneity and progression, providing oversight on the use of biomarker samples from clinical studies for disease area COVID-19 questions, and managing collaborations with external KOLs and technology vendors. This BMST will be a cornerstone to streamline biomarker strategies across the COVID-19 molecule portfolio.
It has been extremely exciting and rewarding to be involved in the effort to fight COVID, as well as to see all of our DevSci colleagues bring together their unique expertise to move these activities forward at lightning speed. We look forward to trial data read-outset of COVASTIL and our other COVID-19 trials, continued learnings and synergistic collaborations across biomarker strategies and teams to deliver now what patients need now.
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