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

Rhea-AI Summary

Aspire Biopharma Holdings (NASDAQ:ASBP) announced that Glatt Air Techniques has completed the first GMP Clinical Batch of its pharmaceutical-grade oral mucosal fast-acting aspirin formulation. The company plans to initiate bioavailability studies in healthy volunteers in April 2025.

The lead product candidate is a high-dose sublingual aspirin in granular or powder form, designed for cardiology emergencies and pain management. The patent-pending delivery system enables rapid sublingual absorption, bypassing the gastrointestinal tract.

Key upcoming milestones include:

• Initial FDA meeting in Q2 2025
• Pharmacodynamic effect clinical trial in Q2 2025
• Fast track approval request for high-dose aspirin
• Clinical trials for low-dose preventative care in Fall 2025
• Expected FDA approval for pain relief application in late 2025

Positive

• Successful completion of first GMP Clinical Batch
• Manufacturing partnership with FDA/EU-approved Glatt Air Techniques
• Multiple potential medical applications for the product
• Patent-pending delivery technology with unique absorption benefits
• Clear regulatory pathway with planned FDA fast track request

Negative

• Product still in early development phase with no FDA approval
• Clinical trials yet to commence
• Potential competition in pain management market
• Extended timeline to market with approval expected late 2025

Insights

Pharmaceutical Development Expert

Aspire Biopharma has reached a significant development milestone with Glatt Air Techniques completing the first GMP clinical batch of their pharmaceutical-grade sublingual aspirin formulation. This represents a important advancement in their product development pathway, transitioning from formulation development to clinical-stage testing.

The completion of GMP manufacturing enables the company to proceed with their planned bioavailability study in April 2025, followed by FDA interactions and clinical trials for various indications. This manufacturing achievement demonstrates technical feasibility of their delivery platform at clinical scale, which reduces one element of execution risk.

Aspire's sublingual delivery technology targets two primary benefits: faster absorption and GI tract bypass. These characteristics could provide meaningful advantages in acute cardiac settings where minutes matter for intervention, as well as in pain management where rapid onset is valued. The platform appears to be targeting multiple market opportunities with the same core technology.

Their regulatory strategy includes seeking fast track designation, which could accelerate their timeline if granted. However, this designation requires demonstration of advantages over existing therapies for serious conditions with unmet needs. The company will need compelling pharmacokinetic data from their upcoming bioavailability study to support this request.

While this manufacturing milestone is important, significant work remains before commercialization. The company must still complete CMC testing, conduct clinical trials demonstrating safety and efficacy, and navigate the regulatory approval process. Their timeline appears ambitious, targeting potential approvals in late 2025, which would require near-perfect execution of their development plan.

The market opportunity for faster-acting aspirin formulations spans emergency cardiac care, pain management, and preventative applications, though each indication will require specific clinical validation and separate regulatory approvals.

Biotech Financial Analyst

Aspire Biopharma's successful completion of GMP manufacturing represents a critical development milestone in their product pipeline, transitioning their lead candidate from formulation development to clinical-stage testing. For a microcap company with $28 million market capitalization, each derisking event carries significant importance.

The manufacturing achievement with Glatt Air Techniques, an established contract manufacturer, validates the technical feasibility of their delivery platform at clinical scale. This long-standing relationship (since 2021) suggests a stable manufacturing partnership, which is important for pharmaceutical development.

The company has outlined an ambitious clinical and regulatory timeline for 2025, including bioavailability studies, FDA interactions, and multiple clinical trials across different indications. Their plan to request fast track designation could accelerate their path to market if granted, though this requires demonstration of meaningful advantages over existing treatments.

Aspire's sublingual delivery technology targets both emergency cardiac care and pain management applications, potentially creating multiple revenue opportunities from a single technology platform. The rapid absorption profile could provide distinct advantages in situations where intervention speed matters, such as suspected heart attacks.

From a financial perspective, advancing to clinical trials represents both a milestone and a challenge. The company will need sufficient capital to fund the planned bioavailability study in April and subsequent clinical trials. While this announcement doesn't address their cash position, the progression to clinical testing typically increases burn rate substantially.

The company's execution of manufacturing and planned transition to clinical testing demonstrates operational progress, though significant development and regulatory hurdles remain before any potential commercialization.

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
kevin@tradigitalir.com

SOURCE: Aspire Biopharma Holdings, Inc.

View the original press release on ACCESS Newswire

FAQ

When will ASBP begin clinical trials for its sublingual aspirin formulation?

Bioavailability studies will begin in April 2025, followed by pharmacodynamic effect trials in Q2 2025.

What are the key advantages of ASBP's sublingual aspirin delivery system?

The system offers faster bloodstream absorption, water solubility, bypass of digestive tract, and easier administration, even for unconscious patients.

What is the timeline for ASBP's FDA approval process?

The company plans FDA meetings in Q2 2025, with expected approval for pain relief applications by late 2025.

How does ASBP's partnership with Glatt Air Techniques impact product development?

Glatt provides FDA and EU-approved manufacturing capabilities, ensuring GMP compliance for clinical batch production since 2021.

What medical conditions will ASBP's sublingual aspirin target?

The product targets cardiology emergencies, pain management, headache relief, post-surgery pain, and cancer pain management.