Aspire Biopharma Holdings, Inc., Provides Update on Recently Filed U.S. Patent Applications for Its Sublingual Drug Delivery Platform

Rhea-AI Summary

Aspire Biopharma Holdings (NASDAQ:ASBP) has provided an update on two patent applications filed with the USPTO for its Oral Mucosal Formulations of Aspirin. The applications, filed on March 31, 2023, and October 2, 2024, focus on the company's fast-acting sublingual drug delivery platform.

The company's lead product candidate is a high-dose sublingual aspirin in granular or powder form, designed for cardiology emergencies and pain management. Key upcoming milestones include:

• Bioavailability study initiation (April 2025)
• Pre-IND FDA meeting (Q2 2025)
• Pharmacodynamic clinical trial (Q2 2025)
• FDA fast-track approval request
• Low-dose aspirin trials (Fall 2025)
• High-dose pain relief NDA submission (late 2025)

The technology offers advantages including rapid absorption, water solubility, improved dosage management, and bypass of the digestive tract.

Positive

• Patent applications filed for innovative sublingual drug delivery platform
• Technology enables faster drug absorption compared to traditional oral medications
• Multiple potential applications in both emergency and chronic care settings
• Clear development timeline with multiple catalysts throughout 2025

Negative

• Patents still pending with no guarantee of approval
• Product efficacy yet to be proven in clinical trials
• Requires new funding to achieve commercialization goals

Insights

Pharmaceutical Development Expert

Aspire Biopharma's patent application updates represent a meaningful step in protecting their sublingual delivery technology. The company has positioned these applications as foundational to their commercial strategy for their sublingual aspirin formulation. This approach offers two critical advantages: bypassing the gastrointestinal tract and enabling rapid absorption directly into the bloodstream.

What's noteworthy is Aspire's clearly defined clinical development timeline spanning 2025. Their lead candidate focuses on high-dose sublingual aspirin with dual applications in emergency cardiac care and pain management. The planned bioavailability study in April, FDA pre-IND meeting in Q2, and pharmacodynamic effects trial represent logical sequential development steps.

From a development perspective, Aspire's technology addresses several well-known pharmaceutical challenges: rapid onset of action, high bioavailability, and reduced gastrointestinal side effects. The powder/granular formulation also solves administration challenges for patients unable to swallow pills or those who are unconscious.

While establishing intellectual property protection is promising, investors should note these remain patent applications rather than granted patents. The regulatory pathway outlined suggests Aspire is pursuing a 505(b)(2) approach, which could accelerate approval by leveraging existing aspirin safety data while demonstrating their novel delivery benefits. This balanced approach could potentially reduce development costs while maintaining exclusivity through their delivery technology.

Intellectual Property Strategist

Aspire's patent strategy demonstrates a deliberate, multi-layered approach to intellectual property protection. By filing two separate applications approximately 18 months apart (March 2023 and October 2024), the company has likely expanded the scope of protection while incorporating additional data and refinements into the more recent filing.

The provisional patent application strategy serves three immediate business purposes: establishing priority dates, enabling "patent pending" marketing claims, and allowing time to refine claims before full utility patent conversion. Most importantly, these applications cover both the formulation and the mechanism of action (absorption pathway) - creating potential barriers to competitive entry.

For a $33.5 million market cap company, this intellectual property strategy is particularly important as it creates potential licensing opportunities beyond their internal development pipeline. The platform technology approach mentioned suggests applicability beyond just aspirin to multiple APIs, which significantly expands potential commercial applications.

The timeline presented indicates Aspire is pursuing a dual-track commercialization strategy: one pathway for high-dose emergency/pain applications and another for low-dose preventative use. This bifurcated approach maximizes the potential market applications while potentially creating multiple approval and revenue streams.

While patent applications don't guarantee granted claims, the specificity around formulation components and absorption mechanisms suggests Aspire is pursuing protectable innovations rather than simply reformulating known technologies. The execution of their outlined clinical program will be the next critical validation point.

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.

Aspire Biopharma Holdings, Inc.

Contact

TraDigital IR
Kevin McGrath
+1-646-418-7002
kevin@tradigitalir.com

SOURCE: Aspire Biopharma Holdings, Inc.

View the original press release on ACCESS Newswire

FAQ

What are the key milestones for ASBP's sublingual aspirin development in 2025?

ASBP plans bioavailability studies in April, FDA Pre-IND meeting and clinical trials in Q2, low-dose trials in Fall, and high-dose pain relief NDA submission by late 2025.

What advantages does ASBP's sublingual drug delivery platform offer?

The platform offers faster bloodstream absorption, water solubility, better dosage management, bypass of digestive tract, and easier administration compared to traditional pills.

When did ASBP file its patent applications for the sublingual aspirin technology?

ASBP filed two patent applications with the USPTO on March 31, 2023, and October 2, 2024.

What therapeutic applications is ASBP targeting with its sublingual aspirin?

ASBP is targeting cardiac emergencies, pain management, headache relief, post-surgery pain, cancer pain management, and preventative care.