Historical brief · 2026-11-13

Regeneron's antibody curbs POTS heart rate spikes in mid-stage trial

Regeneron announced that its experimental monoclonal antibody, baloncibart, met its primary goal in a Phase 2 trial for postural orthostatic tachycardia syndrome, a chronic condition with no FDA-approved treatments.

Source image · BioSpace Drug Development

Clinical Trial Results

Regeneron reported data from its Phase 2 Pinnacle trial evaluating baloncibart, also known as REGN7544, in 82 patients with postural orthostatic tachycardia syndrome (POTS). Patients receiving a 450-mg injection experienced a mean drop in heart rate of 11.4 beats per minute compared to placebo at day eight, while a 150-mg dose reduced heart rate by 9.5 beats per minute. The high-dose group also showed sustained heart rate reductions and reported improvements in physical functioning at day 29.

Mechanism and Development

POTS is a chronic autonomic nervous system disorder associated with lightheadedness and fatigue, with no currently approved treatments. Baloncibart is an NPR1-blocking monoclonal antibody designed to increase blood volume in circulation. Regeneron plans to launch a Phase 3 study in the first half of 2027, building on this mid-stage success.

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