Aspire Biopharma Holdings, Inc., Contract Manufacturer, Glatt Air Techniques, Inc., has Completed Its First Good Manufacturing Practice ('GMP') Clinical Batch of Pharmaceutical Grade Oral Mucosal Fast Acting Formulation of Aspirin

Associated Press

20-03-2025

Subsequent phase involves completion of chemistry, manufacturing, and controls (CMC) testing for data to support FDA submission
Company expects to commence bioavailability study in April 2025
Aspire intends to request 'fast track' approval on FDA application for its high dose aspirin product
HUMACAO, PR AND NEW YORK, NY / ACCESS Newswire / March 20, 2025 / Aspire Biopharma Holdings, Inc. (NASDAQ:ASBP) ('Aspire' or the 'Company'), a developer of a multi-faceted patent pending drug delivery technology, today announced that it its contract manufacturer, Glatt Air Techniques, Inc., part of Glatt Group, a vertically integrated pharmaceutical services company with FDA- and EU-approved sites, has completed its first Good Manufacturing Practice ('GMP') Clinical Batch of its pharmaceutical-grade oral mucosal formulation of aspirin that utilizes Aspire's fast-acting formulation. Aspire's GMP extracts are set to be administered in a bioavailability study in healthy human volunteers in April 2025.
Aspire's lead product candidate, high-dose sublingual aspirin, is a granular or powder formulation of a soluble, Ph neutral, fast-acting aspirin designed to address cardiology emergencies and pain management. Aspire believes the benefits of 'rapid absorption' aspirin include the potential to quickly address cardiac incidents; allow high dose absorption for pain management including fast headache relief, post-surgery, cancer pain management, and general pain relief. The benefits of 'rapid absorption' are to provide nearly instant treatment impact and high dose absorption. The Company's patent pending delivery system includes components specifically formulated to allow rapid sublingual absorption of drugs into the blood stream, thus by-passing the gastrointestinal tract, and potentially provide an improved treatment outcome.
'This marks another important milestone for Aspire,' commented Kraig Higginson, Chief Executive Officer of Aspire. 'We have been collaborating with Glatt Air Techniques since 2021 with the ultimate goal of building a high-quality, cost-effective manufacturing solution for our lead product candidate, high-dose sublingual aspirin. This cooperation enables Aspire to advance our key programs, centered around our patent pending technology, so that we can facilitate delivery of high-quality, safe, and effective therapeutics to individuals seeking relief from pain or when the need arises in cardiology emergencies.'
Glatt Air Techniques has conducted testing and manufacturing of Aspire's GMP Clinical Batch of its oral mucosal fast acting formulation of aspirin under both Pharmaceutical Inspection Co-operation Scheme Good Manufacturing Practice ('PIC/S GMP') and the United States Food and Drug Administration's Current Good Manufacturing Practice regulations.
Following release of the GMP Clinical Batch by Glatt Air Techniques, Aspire intends to initiate the preparation of Chemistry, Manufacturing, and Controls ('CMC') information and conduct clinical trials supporting its planned FDA submission.
Aspirin Product Development and Clinical Trials
Key Potential Features of the Aspire Platform
About Aspire Biopharma, Inc.
Headquartered in Humacao, Puerto Rico, Aspire Biopharma has developed a disruptive technology through a Novel Soluble Formulation which addresses emergencies, drug efficacy, dosage management, and response time. For more information, please visit www.aspirebiolabs.com.
Safe Harbor Statement
Certain statements made in this communication are 'forward-looking statements' within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of words such as 'estimate,' 'projects,' 'expects,' 'anticipates,' 'forecasts,' 'plans,' 'intends,' 'believes,' 'seeks,' 'may,' 'will,' 'would,' 'should,' 'future,' 'propose,' 'potential,' 'target,' 'goal,' 'objective,' 'outlook' and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the financial position, business strategy and the plans and objectives of management for future operations. These statements are based on various assumptions, whether or not identified in this communication, and on the current expectations of Aspire's management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on by any investor as a guarantee, an assurance, a prediction or a definitive statement of fact or probability. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside the control of the parties, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
Aspire Biopharma Holdings, Inc.
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