Regeneron's NPR1 antibody cuts heart-rate spikes in POTS, Phase 3 planned for 2027
- In the 82-patient, placebo-controlled Phase 2 Pinnacle trial, a single dose of baloncibart (REGN7544), an NPR1-blocking antibody, met its primary endpoint of lying-to-standing heart-rate change at day 8.
- The 450 mg dose gave an 11.4 bpm reduction that persisted to day 29 and improved patient-reported function; 150 mg worked at day 8 but not at day 29.
- Safety looked clean, with no discontinuations. Regeneron expects to start Phase 3 in 1H 2027; no POTS drug is approved.
💡 Points Based on public reports
Regeneron has a clean first shot at a disease with no approved therapy and a large, underserved patient base, and the dose-dependent durability at day 29 is the most useful signal. The open questions are the ones Phase 3 must answer: a single injection in 82 patients says little about repeat dosing, and a heart-rate change on standing is a surrogate. Symptom endpoints will decide whether payers and doctors treat this as a real drug.
📰 Source · BioSpace ↗ Regeneron's POTS antibody curbs heart rate spikes, teeing up Phase 3 trial