Regeneron's baloncibart reduces standing heart rate response in Phase 2 POTS trial
REGN•Regeneron said its investigational baloncibart reduced excessive heart-rate increases upon standing in the Phase 2 PINNACLE trial for POTS. A higher dose improved orthostatic symptoms through four weeks, and the company plans a potentially pivotal Phase 3 trial in the first half of 2027.
1. Phase 2 results
Baloncibart reduced excessive heart-rate increases upon standing in the Phase 2 PINNACLE trial for postural orthostatic tachycardia syndrome (POTS). A single higher dose improved orthostatic symptoms through four weeks, while the lower dose’s heart-rate benefit was not sustained. The results were presented for the first time at the American Autonomic Society’s annual meeting.
2. Safety and next steps
Treatment was generally well tolerated, with mostly mild or moderate adverse events. Two serious events occurred, but none prompted discontinuation. Regeneron plans a potentially pivotal Phase 3 trial in the first half of 2027; the brief says POTS has no FDA-approved treatments.
