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MarketScreener Homepage  >  Equities  >  Nasdaq  >  PLx Pharma Inc.    PLXP


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PLx Pharma Inc. Presents Original Abstract and Simultaneous Publication of its Novel, Liquid-Filled Capsule Aspirin Formulation at the 2020 International Stroke Conference

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02/21/2020 | 06:51am EDT

SPARTA, N.J., Feb. 21, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ: PLXP) (“PLx” or the “Company”), a late-stage specialty pharmaceutical company focused on developing more effective and safer products with its patent-protected PLxGuard™ delivery system, announced today the presentation of an original poster on VAZALORE™ 325 mg at the 2020 International Stroke Conference, the premier meeting dedicated to the science and treatment of cerebrovascular disease and brain health, and the simultaneous publication in the Journal of Thrombosis and Thrombolysis.

Abstract Title: Bioavailability of Aspirin in Fasted and Fed States of a Novel Formulation of a Pharmaceutical Lipid-Aspirin Complex

Session Date: Thursday, February 20, 2020, 6:30 PM Pacific Standard Time

Presenter: Dominick J. Angiolillo, MD, PhD, FACC, FESC, FSCAI, Program Director, Interventional Cardiology Fellowship, Professor of Medicine, Director, Cardiovascular Research, University of Florida College of Medicine-Jacksonville, Jacksonville, FL.

Study Design
In this randomized, open label, crossover study, 20 healthy volunteers fasted for at least ten hours and were then randomized as either “fasted,” receiving 650 mg of PL-ASA, or as “fed,” with a standard high-fat meal and 650 mg of PL-ASA 30 minutes later. After a washout of seven days, participants crossed over to the other arm. The primary outcome was comparison of pharmacokinetic (PK) parameters of the stable aspirin metabolite salicylic acid (SA) between fasted and fed states. The results established that PL-ASA may be co-administered with food without significant impact on aspirin bioavailability.

“The data presented at the International Stroke Conference demonstrate that VAZALORE, with its novel delivery platform in a liquid-filled capsule, can deliver aspirin reliably irrespective of whether it is taken on an empty stomach or with food. These findings are clinically important since many clinicians recommend that aspirin be taken with food in order to reduce dyspeptic symptoms, a practice that can lead to erratic aspirin absorption, especially with coated aspirin formulations,” stated Dr. Angiolillo, the lead author of the Journal of Thrombosis and Thrombolysis publication released simultaneously with the presentation.

“Aspirin continues to be the cornerstone of lifelong antithrombotic protection for patients with established atherosclerotic cardiovascular disease. The data presented here, and now published, complement previous studies with this lipid-based formulation of aspirin. It is encouraging that a new formulation of aspirin combining both reliable absorption and antiplatelet effect with improved gastrointestinal safety may soon be available for our patients,” added Deepak L. Bhatt, MD, MPH, FACC, FAHA, FSCAI, FESC, Executive Director of Interventional Cardiovascular Programs Brigham and Women’s Hospital Heart & Vascular Center, Professor of Medicine, Harvard Medical School, and Chairman of the PLx Scientific Advisory Board.

“VAZALORE continues to deliver outstanding results that address important unmet clinical needs of the currently available aspirin formulations. We believe that VAZALORE has the potential to address the long-standing need for a new, better aspirin product, and we will continue our efforts to make VAZALORE available to the millions of high-risk cardiovascular patients who require reliable lifelong vascular protection,” concluded Efthymios N. Deliargyris, MD, FACC, FESC, FSCAI, Chief Medical Officer of PLx Pharma.

VAZALORE 325 mg is an FDA-approved aspirin product developed to provide patients with vascular disease and diabetic patients who are candidates for aspirin therapy with more reliable and predictable antiplatelet efficacy as compared to enteric-coated aspirin, while also reducing the adverse gastric events common in an acute setting. PLx is focused on manufacturing, scale-up and preparing an sNDA for VAZALORE 81 mg maintenance dose form. 

About PLx Pharma Inc.
PLx Pharma Inc. is a late-stage specialty pharmaceutical company focused on developing its clinically validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products. The PLxGuard delivery system works by targeting delivery of active pharmaceutical ingredients (API) to various portions of the gastrointestinal (GI) tract. PLx believes this has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce GI side effects—including erosions, ulcers and bleeding—associated with aspirin and ibuprofen, and potentially other drugs.

To learn more about PLx Pharma Inc. and its pipeline, please visit www.plxpharma.com.

Forward-Looking Statements
Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the prospects for commercializing or selling any products or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to PLx may identify forward-looking statements. PLx cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by PLx to secure and maintain relationships with collaborators; risks relating to clinical trials; risks relating to the commercialization, if any, of PLx’s proposed product candidates (such as marketing, regulatory, product liability, supply, competition, and other risks); dependence on the efforts of third parties; dependence on intellectual property and risks that PLx may lack the financial resources and access to capital to fund proposed operations. Further information on the factors and risks that could affect PLx’s business, financial conditions and results of operations are contained in PLx’s filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Other risks and uncertainties are more fully described in PLx’s Form 10-K for the year ended December 31, 2018 filed with the SEC on March 8, 2019, and in other filings that PLx has made or will make going forward. The forward-looking statements represent PLx’s estimate as of the date hereof only, and PLx specifically disclaims any duty or obligation to update forward-looking statements.

Investor Relations:
Lisa M. Wilson
In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com

Source: PLx Pharma Inc.

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© GlobeNewswire 2020
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EBIT 2020 -15,7 M
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Rita M. O'Connor Chief Financial Officer
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