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
Initiate bioavailability study in healthy human volunteers April 2025
Initial meeting with the FDA in the second quarter of 2025
Commence final clinical trial to evaluate the pharmacodynamic effect of a single dose of our aspirin product on platelet inhibition compared to that of standard oral aspirin in Q2 2025.
Request "fast track" approval for FDA approval of its high dose aspirin product.
Clinical trials in Fall 2025 of our low dose sublingually administered aspirin for preventative care.
High dose sublingually administered aspirin for pain relief (rheumatological and other pain). Building on the previous clinical trial as set forth above, we anticipate obtaining FDA approval in the latter part of 2025.
Key Potential Features of the Aspire Platform
Fast Acting - Powder-form medication developed using our patent-pending technology is expected to enter the bloodstream in a fraction of the time required by swallowed tablets and capsules
Water Soluble - Our products dissolve easily under the tongue
Dosage Management - Drugs do not pass through the liver and not metabolized in the gastric system like oral products
Bypasses the Digestive Tract - Eliminates adverse reactions in the gastrointestinal tract
Easy to use - those who have difficulty swallowing pills can benefit from the expected ease of use our products, even those who are unconscious are expected to be able to receive life-saving medication quickly
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.
Contact
TraDigital IR
Kevin McGrath
+1-646-418-7002
[email protected]
SOURCE: Aspire Biopharma Holdings, Inc.
View the original press release on ACCESS Newswire
W.Knight--TFWP
