Quantum Genomics’ brain-targeting blood pressure drug meets phase 2b endpoints

Quantum Genomics’ blood pressure drug firibastat, an inhibitor that targets aminopeptidase A in the brain, met its primary endpoint in a phase 2b study—which the company says paves the way for a wider phase 3 trial in more resistant hypertension.

Firibastat lowered systolic automatic office blood pressure, or AOBP, by 9.7 mm Hg compared to baseline readings in patients with arterial hypertension, while lowering diastolic pressure by 4.3 mm Hg. Both endpoints reached P values of less than 0.0001.

“A minimum decrease of 7 mmHg in systolic AOBP represents a clinically relevant benchmark in difficult-to-treat hypertensive patients and this goal was largely exceeded in the NEW-HOPE trial,” said Bruno Besse, Quantum Genomics’ chief medical officer.

Firibastat, formerly known as QGC001, is designed to slow the production of angiotensin III, a peptide hormone that has been linked to vasoconstriction pathways that increase blood pressure.

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The study enrolled 256 overweight or obese patients from populations known to have increased incidence of treatment-resistant hypertension, including at least half from African-American or Hispanic backgrounds. Patients received oral firibastat for eight weeks.

“Based on these results and the magnitude of the observed blood pressure decrease, we are encouraged by the outcome of this trial and are optimistic about the promise of firibastat,” Besse added. The phase 2b top-line data were presented at the scientific sessions conference of the American Heart Association.

Firibastat demonstrated efficacy in all of the study’s subgroups, including by age, sex, ethnic origin and weight, the company said. Larger systolic pressure reductions were seen in obese patients, with 10.4 mm Hg, and in black patients, at 10.5 mm Hg—two populations with higher cardiovascular risks, where angiotensin-converting enzyme inhibitors and angiotensin receptor blockers have been marginally effective and are not typically recommended as first-line treatments, the company said.

In addition, the drug was well-tolerated overall, with the most common side effects being skin reactions and headaches, similar to other classes of antihypertensives. No angioedema or changes in serum potassium or sodium levels were observed, while blood glucose levels and renal function remained stable, Quantum said.