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
WALTHAM, Mass., June 01, 2022 (GLOBE NEWSWIRE) — CinCor Pharma, Inc. (“CinCor”) announced today that the first patient has been dosed in the Phase 2 figHTN-CKD trial evaluating baxdrostat (CIN-107), a highly selective aldosterone synthase inhibitor, in patients with uncontrolled hypertension and chronic kidney disease (CKD).
“Over 37 million people in the United States suffer from chronic kidney disease and progressive loss of kidney function. While effective suppression of aldosterone can delay disease progression, long-term hypertensive treatment with current standard-of-care renin-angiotensin-aldosterone system (RAAS) agents is often associated with aldosterone breakthrough,” said Mason Freeman, M.D., Chief Medical Officer at CinCor. “Baxdrostat is a highly selective aldosterone synthase inhibitor that can significantly reduce aldosterone levels, offering the potential to not only improve uncontrolled blood pressure in CKD patients, but also ameliorate the negative impacts of aldosterone on kidney function.”
Marc de Garidel, Chief Executive Officer at CinCor, added, “We are encouraged by the potential broad therapeutic utility of baxdrostat, including its unique potential to inhibit both the genomic and nongenomic effects of aldosterone. We are pleased to dose the first patient in our CKD trial, marking an important initial step in determining the value of baxdrostat in patients with impaired renal function and hypertension.”
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 U.S. adult population, or approximately 37 million people. Hypertension, diabetes and glomerulonephritis, or inflammation of the tiny filters in the kidneys, are considered leading factors contributing to the development and progression of CKD. While currently there is no cure for CKD, new therapies that can significantly reduce the progression of renal disease and delay the onset of renal failure will be critical to improving the care of CKD patients.
About CinCor
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 American College of Cardiology and the American Heart Association as resting blood pressure above 130/80 mm Hg, is generally acknowledged to be one of the most common preventable risk factors for premature death worldwide. Though often asymptomatic, hypertension significantly increases the risk of heart disease, stroke, and kidney disease, amongst other diseases. It is estimated that as much as 20% of the global population suffers from hypertension, including nearly one-half of the adult population in the U.S., or 116 million hypertensive patients.
Forward-Looking Statements
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 Russia and Ukraine and related sanctions against Russia, and matters related thereto; and other risks and uncertainties affecting the company, including those described under the caption “Risk Factors” and elsewhere in CinCor’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the Securities and Exchange Commission (SEC) on March 22, 2022, and other filings and reports that CinCor may file from time to time with the SEC, including its quarterly report on Form 10-Q for the three months ended March 31, 2022 filed with the SEC on May 10, 2022. Other risks and uncertainties of which CinCor is not currently aware may also affect the company’s forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. CinCor undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.
| Contacts: | Investors: |
| Terry Coelho | Bob Yedid |
| CinCor Pharma, Inc. | LifeSci Advisors |
| EVP, CFO and CBDO | ir@CinCor.com |
