HUMACAO, PUERTO RICO AND NEW YORK, NY / ACCESS Newswire / March 13, 2025 / Aspire Biopharma Holdings, Inc. (NASDAQ:ASBP) ("Aspire" or the "Company"), a developer of a multi-faceted patent-pending drug delivery technology, today provided an update on its two patent applications, originally filed as provisional patent applications with the U.S. Patent and Trademark Office ("USPTO") on March 31, 2023 and October 2, 2024, respectively, pertaining to Oral Mucosal Formulations of Aspirin that utilize Aspire's fast acting formulation.
A provisional patent application is a critical step on the road to commercial viability. As the climate for intellectual property rights becomes increasingly competitive, a provisional patent application establishes an early effective filing date for any subject matter disclosed in the provisional application and allows the patent applicant or a licensee to ascribe the phrase "patent pending" to any product or method covered by the provisional application.
"The filing of these patent applications for our innovative drug delivery platform marks another important step in strengthening our intellectual property portfolio and potentially offers a rapid, cost-effective, and scalable way to produce a new therapeutic sublingual form of aspirin," commented Kraig Higginson, Chief Executive Officer of Aspire. "We believe that our technology has the potential to transform sublingual drug delivery by improving the efficacy and safety of a wide range of medications. We are committed to advancing the therapeutic applications of this innovative technology platform to address critical healthcare challenges and improve patient outcomes."
The Company believes its patent pending technology is groundbreaking because it offers significant advantages over existing oral formulations of numerous prescription and non-prescription products due to its new mechanism of action (absorption pathway) which allows for rapid sublingual absorption. 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.
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.
Aspirin Product Development and Clinical Trials
Initiate bioavailability study in healthy human volunteers approximately April 2025
Pre-IND 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 on its NDA for the high dose aspirin product to the FDA.
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 previous clinical trial as set forth above, we anticipate seeking FDA approval, through an NDA, in the latter part of 2025.
Higginson added, "With these critical steps underway, and with new funding, Aspire is committed to achieving key milestones on our path to commercialization."
Aspire believes its platform represents a significant advancement in drug delivery, offering a novel approach to improving the bioavailability of active pharmaceutical ingredients (APIs) and addressing critical challenges in both local and systemic drug delivery. The patent applications underscore Aspire's commitment to securing comprehensive intellectual property protection for its innovative technology, which is designed to improve health and drug delivery.
Key Potential Features of the Aspire Platform
Fast Acting - Powder-form medication developed using our patent-pending technology enters 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 are 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 easily use our products, even those who are unconscious can 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.
