Regeneron Drug Lowers Standing Heart Rate And Improves Symptoms In Heart Disease Study

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) announced Phase 2 PINNACLE trial results showing its investigational antibody baloncibart reduces abnormal standing heart rate spikes and eases symptoms in adults with postural orthostatic tachycardia syndrome (POTS).

The company presented the findings at the American Autonomic Society’s 37th International Symposium on the Autonomic Nervous System.

Targeting Low Blood Volume In POTS

POTS causes heart rate to rise abnormally upon standing, triggering palpitations, dizziness, fatigue, exercise intolerance, cognitive issues, gastrointestinal symptoms, and chronic pain.

Recent estimates indicate the condition affects between 500,000 and several million Americans, mostly young women.

Researchers link POTS to low blood volume. Regeneron designed baloncibart as a monoclonal antibody blocking natriuretic peptide receptor 1 to expand circulating blood volume and curb symptoms.

Phase 2 PINNACLE Trial Efficacy Results

The randomized, double-blind trial tested a single subcutaneous dose of baloncibart 150 mg in 27 patients or 450 mg in 28 patients against placebo in 27 patients.

At day 8, the 450 mg dose reduced the lying-to-standing heart rate change by 11.4 beats per minute versus placebo, maintaining a 7.4 bpm reduction at day 29.

The 150 mg dose cut that change by 9.5 bpm at day 8, without sustaining the benefit through day 29.

On Regeneron’s Living With POTS Questionnaire, the 450 mg dose improved orthostatic symptoms by 12.9 points, physical functioning by 13.8 points, and daily living activities by 8.7 points versus placebo at day 29.

The 150 mg dose showed no clear improvement.

Biomarker Shifts And Safety Profile

Both doses raised NT-proBNP while lowering standing norepinephrine and hemoglobin at day 8, confirming plasma volume expansion. Standing systolic blood pressure rose 8.7 mmHg for 450 mg and 5.4 mmHg for 150 mg at day 29.

Patients tolerated single doses up to 450 mg well.

Mild or moderate adverse events affected 48.1% of placebo patients, 66.7% of the 150 mg group and 67.9% of the 450 mg group. One severe event occurred in the placebo group.

REGN Price Action: Regeneron Pharmaceuticals shares were up 0.09% at $952.01 at the time of publication on Friday. The stock is approaching its 52-week high of $991.73, according to Benzinga Pro data.

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