A UVA Discovery Just Took Its Biggest Step Toward Saving Lives
A therapy developed at the UVA School of Medicine has entered first-in-human clinical trials, a milestone that brings a potential new weapon against two of the deadliest conditions in the intensive care unit: sepsis and acute respiratory distress syndrome (ARDS). The therapy, hCitH3mAb, is the first to directly target a key molecular driver of the runaway inflammation that makes these conditions so difficult to treat.
The research behind hCitH3mAb began with a long-term collaboration between Dr. Jianjie Ma, director of the Division of Surgical Sciences at the UVA School of Medicine, and Dr. Yongqing Li, professor of surgery at the University of Michigan, whose team identified a molecule called CitH3 as a critical driver of the inflammatory escalation that damages organs during severe infections. When the immune system encounters a serious threat, CitH3 can push it past the point of protection and into a cycle that harms the patient. The team developed hCitH3mAb, a monoclonal antibody designed to neutralize CitH3 and break that cycle. “If we can block CitH3, we may be able to prevent the cascade of damage that leads to respiratory failure and death,” Ma said.
If we can block CitH3, we may be ableJMJianjie Ma
to prevent the cascade of damage that leads to respiratory failure and death.
The clinical journey begins with a Phase 1a study evaluating safety, tolerability, and dosing in healthy volunteers, establishing the foundation for patient trials. Pending positive results, the therapy will advance to a multicenter Phase 2a study in patients with sepsis-induced ARDS. That study will assess safety in critically ill patients and look for early signals of the therapy’s impact on inflammation, lung injury, and clinical outcomes. If successful, hCitH3mAb would be the first therapy to target the molecular mechanisms driving ARDS rather than treating its symptoms alone.
The trial also reflects the emerging role of the Paul and Diane Manning Institute of Biotechnology, which is designed to move UVA discoveries into clinical applications more quickly.
This is exactly what the Manning Institute was built to do. The hCitH3mAb program highlights UVA’s ability not only to discover, but to deliver.MEMark Esser
Getting there required partnerships across the research enterprise, including UVA’s Licensing and Ventures Group: the UVA spin-off HTIC, Inc. worked with SparX Biopharmaceutical Corp. to manufacture the antibody to FDA standards, and support from the Virginia Catalyst Program helped advance it through key preclinical and regulatory milestones.
“This clinical trial is the result of coordinated work across research labs, clinical teams, and biotech partners,” Ma said. “Together, we are moving a potential lifesaving therapy into the hands of clinicians.”
This story originally appeared in the 2026 Annual Research Report, produced by the Office of the Vice President of Research. Find more stories from this report here: https://news.research.virginia.edu/category/annual-report/
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Video transcript:
Our research is really broad, in regenerative medicine, aging, diabetes, cancer. Being able to move the stage to start our laboratory discovery, moving into the first humans trial, that is the dream. And we have a team here at UVA. We get all the support from the leadership, from our collaborators.
We reach also outside. We have partners who can manufacture the antibody for us. So it is really a team effort. Within the last three years, we made this far. We are now conducting the clinical trial, and we can put all our energy together so maybe our discovery will bring benefits for the human.