POTS Phase 2 Trial Shows Baloncibart, a First-in-Class NPR1 Blocking Antibody, Reduced Orthostatic Heart Rate and Improved Orthostatic Symptoms
Key Highlights
- ➤Baloncibart 450 mg cut standing heart-rate rise by 11.4 bpm at day 8
- ➤Baloncibart 450 mg improved orthostatic symptoms and physical functioning at day 29
- ➤Phase 3 baloncibart trial planned for the first half of 2027
- ➤Single-dose baloncibart up to 450 mg generally well tolerated; no discontinuations
Expert Statements
Satish R. Raj, Professor of Cardiac Science at the University of Calgary’s Cumming School of Medicine and trial investigator
“POTS causes debilitating symptoms that can profoundly disrupt daily life, and patients have no FDA-approved treatment options. In the trial, a single injection of baloncibart 450 mg reduced the exaggerated heart rate response to standing and improved orthostatic symptoms through four weeks”
Satish R. Raj, Professor of Cardiac Science at the University of Calgary’s Cumming School of Medicine and trial investigator
“The results are consistent with the rationale for NPR1 blockade in POTS, with biomarker changes pointing to an increase in blood volume alongside lower heart rate and better symptoms.”
Boaz Hirshberg, Senior Vice President, Clinical Development, Internal Medicine at Regeneron
“POTS is a condition that disproportionately impacts younger women and has been under-recognized and under-served for too long, which is why it was critical to incorporate the patient experience in our trial design and measure symptoms that reflect how patients actually feel and function”
Boaz Hirshberg, Senior Vice President, Clinical Development, Internal Medicine at Regeneron
“These initial results show the potential of baloncibart for people living with POTS and we look forward to advancing this novel therapy into a Phase 3 clinical trial in 2027.”
Data presented today for the first time at the American Autonomic Society (AAS) annual meeting
POTS (postural orthostatic tachycardia syndrome) is a debilitating condition characterized by a marked increase in heart rate upon standing and associated orthostatic symptoms, with no FDA-approved treatments available
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