CinCor Pharma Doses First Patient in Phase 2 FigHTN-CKD Trial Evaluating the Selective Aldosterone Synthase Inhibitor Baxdrostat (CIN-107) in Patients with Uncontrolled Hypertension and Chronic Kidney Disease
figHTN-CKD is CinCor’s fourth ongoing Phase 2 clinical trial evaluating baxdrostat (CIN-107)
Initial topline data for figHTN-CKD expected in 2H 2023
“Over 37 million people in
The figHTN-CKD trial is a randomized, double-blind, placebo-controlled, multicenter, parallel-group, Phase 2 clinical trial designed to assess the safety and efficacy of baxdrostat (CIN-107) in patients with uncontrolled hypertension and CKD. The trial is designed to enroll 300 patients with a glomerular filtration rate (GFR) of 25-75 ml/min and systolic blood pressure (SBP) greater than 140 mm Hg, or greater than 130 mm Hg if the patient is diabetic. The primary endpoint is the change in SBP after 26 weeks of treatment compared to placebo. Biomarkers of kidney function will also be measured to assess whether aldosterone inhibition by baxdrostat can benefit kidney function beyond the anticipated impact resulting from improved blood pressure control. Initial data for figHTN-CKD is anticipated in the second half of 2023.
CKD is a condition characterized by gradual loss of renal function over time that is measured by GFR, or how much blood the kidneys filter each minute. CKD afflicts at least 15% of the
CinCor, founded in 2018, is a clinical-stage biopharmaceutical company with a mission to bring innovation to the pharmaceutical treatment of cardio-renal diseases. Its lead asset, baxdrostat (CIN-107), a highly selective, oral small molecule inhibitor of aldosterone synthase, is in clinical development for the treatment of hypertension and primary aldosteronism.
About Baxdrostat (CIN-107)
Baxdrostat (CIN-107) is a highly selective, oral small molecule inhibitor of aldosterone synthase, the enzyme responsible for the synthesis of aldosterone in the adrenal gland, in development for patient populations with significant unmet medical needs, including treatment-resistant hypertension and primary aldosteronism. Hypertension, which is defined by the
This press release contains certain forward-looking statements, including, but not limited to, statements related to CinCor’s business in general; the results and timing of CinCor’s ongoing and planned clinical trials, including its figHTN-CKD trial; the anticipated timing of disclosure of results of clinical trials, including for figHTN-CKD; the progress of CinCor’s research and development programs and clinical trials and studies, including enrollment and retention in clinical trials; plans for initiating future clinical trials and studies; the therapeutic potential of baxdrostat (CIN-107), including its potential to be an effective treatment for patients with uncontrolled hypertension and CKD; CinCor’s clinical milestones and pipeline; expectations with respect to regulatory matters; expectations with respect to potential market size; and other statements that are not historical facts. Because such statements are subject to risks and uncertainties, actual results may differ from those expressed or implied by such forward-looking statements. Words such as “anticipates,” “believes,” “expected,” “intends,” “plan,” “may”, “will,” “project”, “estimate”, “continue,” “advance” and “future” or similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on CinCor’s current plans, objectives, estimates, expectations and intentions, involve assumptions that may never materialize or may prove to be incorrect and inherently involve significant risks and uncertainties, including factors beyond CinCor’s control, that could cause actual results, performance, or achievement to differ materially and adversely from those anticipated or implied in the statements, including, without limitation, CinCor has incurred significant operating losses since its inception; CinCor has a limited operating history and no history of commercializing products; CinCor will require substantial additional funding to finance its operations; CinCor’s business is entirely dependent at this time on the success of one drug, baxdrostat; initial, interim, “top-line” and preliminary data from clinical trials announced or published from time to time may change; CinCor may not be successful in its efforts to expand its pipeline beyond baxdrostat; success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials; enrollment and retention of patients in clinical trials could be delayed; CinCor relies and will rely on third parties to conduct, supervise and monitor existing clinical trials and potential future clinical trials; developments from the company’s competitors and the marketplace for the company’s products; and CinCor’s business, operations and clinical development timelines and plans may be adversely affected by the evolving and ongoing COVID-19 pandemic and geopolitical events, including the ongoing military conflict between
|EVP, CFO and CBDO||ir@CinCor.com|
Source: CinCor Pharma, Inc.