Aspire Biopharma advances to phase 1 clinical trial for aspirin product

Published 25/02/2025, 13:44
Aspire Biopharma advances to phase 1 clinical trial for aspirin product

HUMACAO, PUERTO RICO AND NEW YORK, NY - Aspire Biopharma Holdings, Inc. (NASDAQ:ASBP), a pharmaceutical company specializing in drug delivery technologies, has completed an initial feasibility study of its high-dose sublingual aspirin product and is preparing to enter Phase 1 clinical trials in April, the company announced today. The announcement comes as ASBP shares trade at $2.10, down over 80% year-to-date, according to InvestingPro data.

The study, conducted by Glatt Air Techniques, Inc., a member of the Glatt Group, confirmed the feasibility of Aspire’s aspirin formulation for further development. The product, which offers a granular or powder form of soluble, Ph neutral, fast-acting aspirin, is intended for use in cardiology emergencies and pain management. It aims to provide rapid absorption into the bloodstream, which could be critical in stopping heart attacks and strokes and managing pain.

Glatt’s testing validated Aspire’s analytical methods for manufacturing under cGMP standards, confirmed the purity of ingredients, and established the compatibility of the active ingredient with other components and flavors. These findings are significant as they support the progression of Aspire’s lead product candidate toward clinical evaluation.

Kraig Higginson, CEO of Aspire, underscored the importance of the milestone, stating that the data builds on previous reports and paves the way for the upcoming clinical tests. The company anticipates a series of milestones in 2025, including progress meetings with the FDA, commencement of final clinical trials for platelet inhibition comparison, and requests for rapid approval of the high-dose aspirin product. InvestingPro analysis reveals the company faces financial challenges, with a current ratio of 0.19 and negative free cash flow, highlighting the importance of successful clinical trials for the company’s future. Additional plans involve testing low-dose aspirin for preventative care, a testosterone formulation, a semaglutide product, and other non-prescription products utilizing Aspire’s sublingual delivery method.

Aspire’s forward-looking statements indicate an ambitious year ahead, with multiple products in the pipeline set to reach various stages of development and approval processes. The company’s strategy appears to focus on leveraging the established safety and efficacy data of aspirin to accelerate approval and reduce costs.

This news is based on a press release statement and represents a potentially significant advancement in the field of drug delivery systems, with implications for patient care and treatment options in emergencies and pain management. Aspire Biopharma’s stock performance and investor interest may be influenced by these developments as they unfold throughout the year. InvestingPro subscribers have access to additional insights, including 7 more ProTips and comprehensive financial health metrics that can help evaluate the investment potential of ASBP as it progresses through these crucial development stages.

In other recent news, Aspire Biopharma has completed its merger with PowerUp Acquisition Corp., a special purpose acquisition company. This merger, which closed on February 17, 2025, has resulted in Aspire Biopharma’s common stock and warrants beginning to trade on the Nasdaq Global Market and Nasdaq Capital Market. The merger is expected to enhance Aspire Biopharma’s access to capital markets, facilitating expansion in product development and strategic partnerships. Additionally, the company is advancing its fast-absorbing aspirin, which is considered a strong candidate for expedited FDA approval.

The agreement between Aspire Biopharma and PowerUp was initially announced in September 2024, with the merger receiving approval from PowerUp stockholders by the end of January 2025. Legal counsel for the transaction was provided by Dykema Gossett, PLLC for PowerUp and Sichenzia Ross Ference Carmel LLP for Aspire Biopharma. Aspire’s sponsors and certain equity holders have entered into a lockup agreement, which is anticipated to provide leadership stability for the combined entity. These developments are part of Aspire Biopharma’s strategy to improve drug efficacy and response time in emergency situations.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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