CinCor Pharma Announces Publication of Phase 1 Multiple Ascending Dose Study Data in Hypertension Research – Bio Tech Winners
Last Updated on October 21, 2022 by GlobeNewsWire
WALTHAM, Mass., Oct. 21, 2022 (GLOBE NEWSWIRE) — CinCor Pharma, Inc. (NASDAQ: CINC) today announced the publication of Phase 1 clinical data for baxdrostat, a highly selective, once daily, oral small molecule inhibitor of aldosterone synthase, in the journal Hypertension Research.
The publication includes clinical data from the company’s randomized, Phase 1, placebo controlled multiple ascending dose (MAD) study evaluating the safety, pharmacokinetics, and pharmacodynamics of baxdrostat in healthy volunteers. These data demonstrate baxdrostat is well tolerated with a half-life that supports once-daily oral dosing. The dose-dependent reduction in plasma aldosterone and lack of impact on cortisol reinforce the selective blockade of aldosterone synthase by baxdrostat.
“We believe these proof-of-concept data support further clinical advancement of this promising new treatment for hypertension,” said Mason Freeman, M.D., Chief Medical Officer at CinCor. “Importantly, these data provide the first clinical evidence that an aldosterone synthase inhibitor can block aldosterone production without impacting cortisol and support a well-tolerated and well-behaved pharmacokinetic profile across all doses of baxdrostat tested.”
The full manuscript, titled “Results from a phase 1, randomized, double-blind, multiple ascending dose study characterizing the pharmacokinetics and demonstrating the safety and selectivity of the aldosterone synthase inhibitor baxdrostat in healthy volunteers” can be found at the following link: https://rdcu.be/cXXng.
About CinCorCinCor, 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, a highly selective, oral small molecule inhibitor of aldosterone synthase, is in clinical development for the treatment of hypertension and primary aldosteronism.
About BaxdrostatBaxdrostat (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 StatementsThis press release contains certain forward-looking statements, including, but not limited to, the therapeutic potential of baxdrostat (CIN-107), including expectations with respect to further clinical advancement of baxdrostat, the potential therapeutic benefits of baxdrostat, the potential of baxdrostat to be a promising new treatment for hypertension and the ability of baxdrostat to address multiple unmet needs in patients; expectations with respect to regulatory matters; 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, geopolitical events, including the ongoing military conflict between Russia and Ukraine and related sanctions against Russia, and macroeconomic conditions, including rising inflation and uncertain credit and financial markets, 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, quarterly report on Form 10-Q for the three months ended June 30, 2022 filed with the SEC on August 8, 2022, and other filings and reports that CinCor may file from time to time with the SEC. 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 CoelhoBob YedidCinCor Pharma, Inc.LifeSci AdvisorsEVP, CFO and CBDOir@CinCor.com