PhaseBio Announces Acquisition of Novel Oral Aldosterone Synthase Inhibitor to Develop for Treatment-Resistant Hypertension
January 13 2020 - 4:01PM
PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage
biopharmaceutical company focused on the development and
commercialization of novel therapies for cardiopulmonary diseases,
today announced that it has signed an agreement with Viamet
Pharmaceuticals Holdings, LLC and its wholly-owned subsidiary,
Selenity Pharmaceuticals (Bermuda), Ltd., to acquire all of the
assets and intellectual property rights related to certain novel
aldosterone synthase inhibitors, including the company’s lead
development compound formerly known as SE-6440 or VT-6440. PhaseBio
will designate the lead development compound as PB6440, which
PhaseBio plans to develop for treatment-resistant hypertension.
Terms of the agreement include an upfront payment by PhaseBio,
development, approval, and net sales milestones and tiered
royalties on global net sales.
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 Jonathan Mow, Chief Executive Officer of
PhaseBio. “Despite a broad array of therapeutic options available
to manage blood pressure, a significant proportion of hypertensive
patients are still not achieving the increasingly stringent
blood-pressure goals set by the American College of Cardiology and
the American Heart Association. PB6440 represents an exciting, new
potential treatment option for patients with treatment-resistant
hypertension, and we believe it is an excellent strategic fit with
PhaseBio’s pipeline of novel therapies for specialty cardiovascular
diseases with high unmet need.”
John Lee, M.D., Ph.D., Chief Medical Officer of
PhaseBio, said, “Over the past decade, the dramatic decline in
research and development focused on novel treatment options for
hypertension, coupled with an alarming increase in global obesity
rates, has led to a very high unmet need for novel approaches to
blood pressure management. Recent draft guidance from the U.S. Food
and Drug Administration highlights this unmet need and describes a
streamlined regulatory path for novel drugs to treat resistant
hypertension without the need for large outcomes studies.1 Based on
data seen to date, we believe targeting elevated aldosterone levels
in patients with hypertension who are not adequately controlled on
a background of multiple antihypertensive drugs represents a
promising new approach. We are excited to have the opportunity to
advance PB6440 as part of our growing portfolio of novel
cardiovascular therapies.”
About PB6440
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
About PhaseBio
PhaseBio Pharmaceuticals, Inc. is a
clinical-stage biopharmaceutical company focused on the development
and commercialization of novel therapies for cardiopulmonary
diseases. The company’s pipeline includes: PB2452, a novel reversal
agent for the antiplatelet therapy ticagrelor; PB1046, a
once-weekly vasoactive intestinal peptide receptor agonist for the
treatment of pulmonary arterial hypertension; and PB6440 for the
treatment of resistant hypertension. PhaseBio’s proprietary
elastin-like polypeptide (“ELP”) technology platform enables the
development of therapies with potential for less-frequent dosing
and improved pharmacokinetics, including PB1046, and drives both
internal and partnership drug development opportunities.
PhaseBio is located in Malvern, PA and San Diego, CA. For more
information, please visit www.phasebio.com.
Forward-Looking Statements
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.
Investor Contact:
John SharpPhaseBio Pharmaceuticals, Inc. Chief Financial
Officer(610) 981-6506john.sharp@phasebio.com
Media Contact:
Gina Cestari6 Degrees(917) 797-7904gcestari@6degreespr.com
_____________________________________________________________________________________
- U. 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.
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