CinCor Pharma Announces Last Patient Randomized in Phase 2 HALO Trial and Initiation of Long-Term Extension Study for Baxdrostat, a Selective Aldosterone Synthase Inhibitor, in Uncontrolled Hypertension
Open Label Extension Study Will Evaluate Baxdrostat for Up to 52 Weeks
Topline Data for Phase 2 HALO Trial Expected in 2H 2022
Topline Data for Phase 2 BrigHtn Trial Expected in
“Despite being on one or more different classes of antihypertensive agents, approximately 50 million Americans still fail to achieve blood pressure control. Baxdrostat is designed to selectively reduce aldosterone production, potentially offering a new mechanism that directly targets a key underlying cause of hypertension,” said
The HALO trial is an ongoing Phase 2 randomized, double-blind, placebo-controlled, multicenter, parallel-group, clinical trial designed to assess the safety and efficacy of baxdrostat in subjects taking up to two antihypertensive agents at their maximally tolerated dosages. The HALO trial completed enrollment with 249 patients randomized. The primary endpoint of the trial is the change in systolic blood pressure (SBP) after eight weeks of treatment. Background antihypertensive therapy will be discontinued after eight weeks and patients will only take baxdrostat for four additional weeks to characterize monotherapy responses and to enable long-term safety assessments of the drug in the open label extension study that follows the HALO trial. Topline data from the HALO trial is expected in the second half of 2022, and the open-label extension trial is expected to be completed in the second half of 2023.
CinCor, founded in 2018, is a clinical-stage biopharmaceutical company with a mission to bring innovation to the pharmaceutical treatment of hypertension and other 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 HALO and the open-label extension study; the anticipated timing of disclosure of data and results of clinical trials and studies, including for HALO and the open-label extension study; the progress of CinCor’s research and development programs and clinical trials and studies, including enrollment and retention in clinical trials and studies; 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; 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,” “design,” 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.