PhaseBio Announces Acquisition of Novel Oral Aldosterone Synthase Inhibitor to Develop for Treatment-Resistant Hypertension
PhaseBio will be responsible for all development, manufacturing and commercialization of PB6440. In preclinical studies completed to date, PB6440 was observed to be a highly potent and selective inhibitor of aldosterone synthase (CYP11B2) versus the closely-related steroid 11β-hydroxylase enzyme (CYP11B1). PB6440 demonstrated dose-dependent aldosterone reduction without a significant increase in 11-deoxycorticosterone or deoxycortisol in both rodent and primate models. The oral bioavailability and pharmacokinetic profiles appear suitable for once-daily dosing in humans. To date, no evidence of toxicity has been observed in either in vitro toxicity studies or in animal models, including primates. PhaseBio is planning to initiate clinical development of PB6440 pending the completion of nonclinical Investigational New Drug Application (“IND”)-enabling studies planned for 2020, which are expected to be followed by an IND filing and a first-in-human study in early 2021.
“Hypertension is one of the key risk factors for cardiovascular disease and has been linked to significant morbidity and mortality,” said
PB6440 is a highly selective aldosterone synthase inhibitor being developed for treatment-resistant hypertension. PB6440 modulates the renin-angiotensin-aldosterone system, which plays a critical role in regulation of systemic blood pressure. Despite the broad range of currently available antihypertensive therapies, approximately 10 million, or 20%, of drug-treated U.S. hypertension patients have not achieved target blood-pressure lowering while on three or more antihypertensive medications.2 These patients with treatment-resistant hypertension are at a significantly greater risk for major adverse cardiovascular events, including heart attack, stroke, and heart failure, as well as peripheral artery disease and kidney failure.3
PhaseBio is located in
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “expects,” “intends,” “projects,” and “future” or similar expressions are intended to identify forward-looking statements.
Forward-looking statements include statements concerning or implying the conduct or timing of our preclinical studies and clinical trials, timelines for regulatory submissions and our research, development and regulatory plans for PB2452, PB1046, PB6440 and our ELP research programs. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements.
Risks regarding our business are described in detail in our Securities and Exchange Commission filings, including in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2019. These forward-looking statements speak only as of the date hereof, and PhaseBio Pharmaceuticals, Inc. disclaims any obligation to update these statements except as may be required by law.
Chief Financial Officer
S. Food and Drug Administration. Center for Drug Evaluation and Research. (2018) Hypertension: Conducting Studies of Drugs to Treat Patients on a Background of Multiple Antihypertensive Drugs Guidance for Industry. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/hypertension-conducting-studies-drugs-treat-patients-background-multiple-antihypertensive-drugs
- Carey RM, Sakhuja S, Calhoun DA, Whelton PK, Muntner P. Prevalence of apparent treatment‐resistant hypertension in
the United States: comparison of the 2008 and 2018 American heart association scientific statements on resistant hypertension. Hypertension. 2019; 73: 424‐ 431.
- Muntner P, Davis BR,
Cushman WC, et al. Treatment-resistant hypertension and the incidence of cardiovascular disease and end-stage renal disease: results from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) Hypertension. 2014;64:1012–1021.
Source: PhaseBio Pharmaceuticals, Inc.