PLx Pharma Inc. Announces New Scientific Data Available Evaluating the Pharmacologic Profile of FDA-Approved VAZALORE 81 mg Liquid-Filled Aspirin Capsules

Rhea-AI Summary

PLx Pharma has announced new findings regarding its VAZALORE 81 mg liquid-filled aspirin capsules, demonstrating rapid bioavailability and effective platelet inhibition. Data presented at the TCT 2021 meeting indicates that VAZALORE 81 mg has pharmacokinetic and pharmacodynamic profiles consistent with its 325 mg counterpart. A crossover study showed significant absorption and platelet aggregation inhibition after a single dose. PLx Pharma emphasizes the potential for VAZALORE to enhance drug absorption while minimizing stomach injury risks. The company sees this as a vital addition to the clinical data supporting its FDA-approved products.

Positive

• VAZALORE 81 mg shows fast and reliable absorption after a single dose.
• Demonstrated potent and early inhibition of platelet aggregation.
• The pharmacokinetic and pharmacodynamic profiles align with the 325 mg dose, reinforcing product efficacy.
• The study's findings contribute to the existing clinical evidence supporting VAZALORE's approval.

Negative

• None.

-- VAZALORE 81 mg shows fast bioavailability, absorption, and platelet inhibition --

-- VAZALORE 81 mg has pharmacokinetic and pharmacodynamic profiles consistent with
VAZALORE 325 mg --

-- Findings presented at TCT meeting earlier today --

SPARTA, N.J., Nov. 04, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ: PLXP) (“PLx” or the “Company”), is a specialty pharmaceutical company focused on its clinically-validated and patent-protected PLxGuard^TM drug delivery platform that has the potential to improve the absorption of many drugs currently on the market and to reduce the risk of stomach injury associated with certain drugs. The Company, with its lead products VAZALORE^TM 325 mg and VAZALORE^TM 81 mg liquid-filled aspirin capsules (referred to together as “VAZALORE”), today announced the availability of additional scientific data that builds upon the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of VAZALORE 81 mg and compared with enteric coated aspirin (EC-ASA).

PLx Pharma conducted a randomized, open-label, crossover study where preliminary results showed VAZALORE 81 mg provided fast and reliable absorption after a single dose. In addition, VAZALORE 81 mg provided potent and early inhibition of platelet aggregation. The results of this study titled, Pharmacokinetic and Pharmacodynamic Profile of PL-ASA, a Novel Phospholipid-Aspirin Complex Liquid Formulation, Compared to Enteric-coated Aspirin at an 81 mg Dose – Results from a Prospective, Randomized Crossover Study (F. Franchi et al.), were included in a virtual poster presentation during the Transcatheter Cardiovascular Therapeutics Meeting of the Cardiovascular Research Foundation (TCT 2021) in Orlando, FL. To access the poster, click here https://tct2021.crfconnect.com/abstracts, register and once signed in, search for abstract ‘TCT 320’ or author ‘Franchi’ to view the pdf.

“This was the first study to investigate the PK/PD parameters of the 81 mg dose of VAZALORE and, as expected, the results were consistent with previous findings from published pharmacologic studies with the 325 mg,” said Lead Investigator Francesco Franchi, M.D., Assistant Professor of Medicine – Department of Medicine, Division of Cardiology at the University of Florida College of Medicine –Jacksonville.

“We are excited that these findings provide additional clinical information about our FDA-approved VAZALORE liquid-filled aspirin capsules, beyond the first studies that supported approval of VAZALORE 81 mg and VAZALORE 325 mg,” said Natasha Giordano, President and CEO of PLx Pharma.

About VAZALORE
VAZALORE is an FDA-approved liquid-filled aspirin capsule, available in 81 mg and 325 mg doses. VAZALORE delivers aspirin differently from plain and enteric coated aspirin products. The special complex inside the capsule allows for targeted release of aspirin, limiting its direct contact with the stomach.  VAZALORE delivers fast, reliable absorption for pain relief plus the lifesaving benefits of aspirin. To learn more about VAZALORE, please visit www.vazalore.com.

About PLx Pharma Inc. 
PLx Pharma, Inc. is a specialty pharmaceutical company focused on improving how active pharmaceutical ingredients (APIs) are absorbed in the gastrointestinal (GI) tract via its clinically validated and patent protected PLxGuard™ drug delivery platform.  PLx believes this platform has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce the risk of stomach injury associated with certain 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, 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, 2020 filed with the SEC on March 12, 2021, 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.

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

Source: PLx Pharma Inc. 

FAQ

What were the key findings from PLx Pharma's VAZALORE 81 mg study presented at TCT 2021?

The study showed that VAZALORE 81 mg has fast absorption and effective platelet inhibition, consistent with the 325 mg version.

What is the significance of VAZALORE's pharmacokinetic profile?

The pharmacokinetic profile indicates reliable absorption, which may enhance effectiveness while reducing stomach injury risks.

What is PLXP and what does it represent?

PLXP refers to PLx Pharma Inc., whose stock is listed on NASDAQ.

When was the VAZALORE 81 mg study conducted?

The study results were presented on November 4, 2021, at the TCT 2021 meeting.