Featured Clinical Trial: Spark-PA

A new highly selective aldosterone synthase inhibitor (CIN-107) is being developed for resistant hypertension and primary aldosteronism.

Phase 1 single ascending dose clinical study established that the investigational drug is well tolerated, and demonstrated specificity for aldosterone inhibition with significant dose-dependent aldosterone lowering effect.

The investigational drug has now entered Phase 2 clinical study to determine dose selection. Volunteers are given either one of the 3 doses being tested or a placebo. Recruitment has started at one location: 2000 Crawford St, Suite 1125 in Houston, TX 77002. Additional sites will be added in the future in Birmingham, AL; Phoenix, AZ; Greenbrae, CA; San Francisco, CA; Baltimore, MD; Ann Arbor, MI; and Rochester, MN.

Additional information on the study drug, qualification and clinic locations can be found on the trial’s website

CinCor is responsible for all development, manufacturing and commercialization of CIN-107.

This is very encouraging news! Patients with primary aldosteronism are invited to participate in the clinical trial.

To qualify, patients must be:

  • Adults (18 years of age or older) with a diagnosis or suspected diagnosis of PA;
  • Able to wash out of protocol-specified antihypertensive medication(s) for up to 4 weeks and remain washed out for the duration of the study treatment period; and
  • Willing to take allowed, protocol-specified medication(s), if needed, to maintain BP within protocol parameters.

The study’s exclusion criteria include:

  • Seated SBP ≥ 180 mmHg or DBP ≥ 110 mmHg;
  • BMI <40 kg/m2 and an arm circumference below 7 inches or above 17 inches;
  • Previous surgical intervention or planned surgical intervention for an adrenal adenoma or adrenal carcinoma, adrenalectomy, renal nerve denervation, or adrenal ablative procedure during the course of the study;
  • Documented estimated glomerular filtration rate <60 mL/min/1.73m2;
  • Planned dialysis or kidney transplantation during the course of the study;
  • Documented chronic heart failure;
  • Stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before the Screening Visit;
  • Current severe left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy and/or severe aortic valvular disease, diagnosed from a prior echocardiogram;
  • Previously or planned within 6 months of the Screening Visit, coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG]) or any major surgical procedure during the study;
  • Chronic permanent atrial fibrillation;
  • On night shifts during the course of the study;
  • Consumption of >14 alcoholic drinks weekly;
  • Potassium <2.5 mEq/L; and,
  • Potassium >5.0 mEq/L.l