Initial feasibility study of its soluble, Ph neutral, fast acting granular or powder drug delivery system is complete
Test results support the next development step with Phase 1clinical trial expected to commence in April
Provides Summary of Expected 2025 Milestones
HUMACAO, PUERTO RICO AND NEW YORK, NY / ACCESS Newswire / February 25, 2025 / Aspire Biopharma Holdings, Inc. (NASDAQ:ASBP) ("Aspire" or the "Company"), a developer of a multi-faceted patent-protected disruptive drug delivery mechanism technology, announced today that Glatt Air Techniques, Inc., part of Glatt Group, a vertically integrated pharmaceutical services company with FDA- and EU-approved sites operating under cGMP conditions, has undertaken FDA-required testing of the Company's high-dose sublingual aspirin product. Based on the feasibility study, Aspire has begun preparations and expects its next phase of clinical trial to commence in April.
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 stop heart attack and stroke; allow high dose absorption for pain management including fast headache relief, post-surgery, cancer pain management, and general pain relief.
The Company's formulation was deemed feasible for further development based on the following testing reports provided by Glatt:
Validated Aspire's analytical methods for manufacturing the product under cGMP standards.
Demonstrated that the aspirin and other ingredients purchased for the testing batch of our high-dose aspirin product meets cGMP and FDA standards for purity.
Proved through a compatibility study that the active ingredient (aspirin) is compatible with the incipient ingredients without issues that could occur in the packaged final product.
Established baselines for our stability testing to assure appropriate shelf-life.
Verified the two flavors our high-dose aspirin will use (orange and lemon lime) are chemically compatible with the product's other ingredients.
Based on the growing volume of pre-clinical data reported by the Company, management believes clear proof-of-concept has been established for its underlying delivery technology.
"Today's announcement represents a significant milestone for Aspire, and we believe the speed and level of absorption due to our new mechanism of action into the blood stream is significant and represents a new disruptive drug delivery technology," commented Kraig Higginson, Chief Executive Officer of Aspire. "The feasibility data of our high-dose sublingual aspirin announced today builds on the strong data reported to date, as we work to finalize the path forward for next round of clinical testing in April 2025. We look forward to advancing the study to bring an innovative treatment option to patients and further demonstrate that our novel drug delivery technology will support the lifecycle of Aspire's drug and nutraceutical development pipeline."
High-dose, sublingual aspirin - Aspire's Expected Lead Product
Aspire's lead product, which addresses cardiology emergencies and pain management, is a granular or powder formulation of a soluble, Ph neutral, fast-acting aspirin. Aspire believes the benefits of "rapid absorption" aspirin include the potential to quickly stop heart attack and stroke; allow high dose absorption for pain management including fast headache relief, post-surgery, cancer pain management, and general pain relief. Aspire is in the process of seeking approval from the U.S. Food and Drug Administration ("FDA") for its aspirin product. Aspire can reference the well-known and fully established safety and efficacy data of the original innovator drug (aspirin) which can accelerate the approval process and reduce associated costs.
Summary of 2025 Expected Milestones
Looking forward, the Company expects to achieve a number of significant milestones in fiscal 2025. These include:
Aspirin Products
Initial trial and report high level results
Progress meeting with the FDA in the early second quarter of 2025 in conjunction with application
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 rapid approval for the high dose aspirin product from 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, in the latter part of 2025.
Non-aspirin Prescription Drug Products
Testosterone formulation for sublingually administered testosterone. Aspire will conduct a Phase 1 clinical test in the third quarter of 2025 for pharmokinetical validation of product properties to establish criteria for an NDA with the FDA. Aspire anticipates, based on these results, to request a pre-IND meeting with the FDA in the fourth quarter of 2025, followed by Phase 2 clinical testing.
Semaglutide formulation for a sublingual semaglutide product is nearly complete; FDA approval process to start in late 2025.
Early studies of migraine rapid relief product to be delivered via Aspire's rapid drug delivery technology in early Q3 2025.
Erectile dysfunction (sildenafil/tadalafil) formulation development in Q4 2025.
Non-prescription Products
Pre-workout product using our sublingual delivery method is expected to launch in Q2 2025.
Melatonin product for a sublingually administered, rapid-delivery melatonin sleep-aid product expected to launch in Q3 2025.
Vitamin development formulation for sublingually administered vitamins D, E and K 2H 2025.
About Aspire Biopharma, Inc.
Headquartered in Humacao, Puerto Rico, Aspire Biopharma has developed a disruptive technology for rapid product delivery 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.
