Baxdrostat (CIN-107) selectively targets aldosterone synthase, which is encoded by the CYP11B2 gene. Importantly, it has low affinity for 11ß-hydroxylase, the enzyme responsible for cortisol synthesis, which is encoded by the CYP11B1 gene. In multiple preclinical in vivo studies, baxdrostat (CIN-107) significantly lowered aldosterone levels without affecting cortisol levels, across a wide range of doses. Similar observations were made in multiple Phase 1 clinical trials in healthy volunteers.
To date, multiple Phase 1 clinical trials of baxdrostat (CIN-107) have been conducted in healthy volunteers to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of baxdrostat (CIN-107). Baxdrostat (CIN-107) was well tolerated in healthy volunteers across all Phase 1 clinical trials conducted to date, with no serious adverse events, or SAEs, or treatment-emergent adverse events, or TEAEs, leading to treatment withdrawal associated with baxdrostat (CIN-107).
In addition, a Phase 1 clinical trial was conducted in subjects with varying degrees of renal function. In this trial, one SAE not related to baxdrostat (CIN-107) was observed.
Based on the preclinical and clinical data available to date, we are developing baxdrostat (CIN-107) in multiple diseases where aldosterone plays a significant role in disease pathophysiology, including hypertension and primary aldosteronism. We are also exploring its utility in ameliorating complications of chronic kidney disease.
About Treatment-Resistant Hypertension
Treatment-resistant hypertension (rHTN) is usually diagnosed when a person’s hypertension medications are no longer helping lower his or her blood pressure.
One potential cause of treatment-resistant hypertension is a build-up of a chemical called aldosterone, which helps regulate blood pressure. Many hypertension medications are designed to lower the amount of aldosterone in the body. However, aldosterone levels can sometimes increase even if you are taking medications to reduce it. This makes it difficult to control blood pressure.
The study drug is designed to work with your current medications to reduce aldosterone.
About Primary Aldosteronism
Primary aldosteronism (PA) is a condition caused by overactive adrenal glands, causing the body to create too much of a hormone called aldosterone. This hormone helps the body manage the amount of sodium and potassium in the body.
When aldosterone increases, your body holds on to more water, causing blood pressure to go up.
To learn more about our clinical research study, visit https://spark-pa.com/.
Ongoing Clinical Trials
We are currently evaluating baxdrostat (CIN-107) in four Phase 2 clinical trials for hypertension, hypertension in CKD and primary aldosteronism.
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of 3 Doses of CIN-107 as Compared to Placebo After 12 Weeks of Treatment in Patients With Treatment-Resistant Hypertension
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of CIN-107 for the Treatment of Patients With Primary Aldosteronism
- A Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Dose Strengths of CIN-107 as Compared to Placebo After 8 Weeks of Treatment in Patients with Uncontrolled Hypertension Receiving 1 Antihypertensive Agent
To learn more about our clinical study of baxdrostat (CIN-107), visit www.ClinicalTrials.gov.