Aspire Biopharma Holdings, Inc., Announces Phase 1 Clinical Trial Initiation of its Oral Transmucosal Fast-Acting High-Dose Aspirin Formulation
Aspire Biopharma Holdings (NASDAQ:ASBP) has initiated a Phase 1 clinical trial for its oral transmucosal fast-acting high-dose aspirin formulation. The single-center study will evaluate safety, pharmacokinetics, and pharmacodynamics of their sublingual aspirin powder.
The trial will enroll 6-8 participants in April 2025, comparing a 162.5mg sublingual aspirin powder dose against conventional oral aspirin. The primary outcome measure focuses on plasma acetylsalicylic acid concentration over 24 hours.
The company plans to request a pre-IND FDA meeting in Q2 2025 to discuss development plans for a 505(b)(2) NDA submission. The product aims to treat suspected acute myocardial infarction, with potential benefits including rapid absorption, improved bioavailability, and reduced gastric irritation. Initial clinical data is expected by the end of Q2.
Aspire Biopharma Holdings (NASDAQ:ASBP) ha avviato uno studio clinico di Fase 1 per la sua formulazione di aspirina ad alto dosaggio ad azione rapida per via transmucosa orale. Lo studio, condotto in un unico centro, valuterà la sicurezza, la farmacocinetica e la farmacodinamica della loro polvere di aspirina sublinguale.
Il trial arruolerà 6-8 partecipanti ad aprile 2025, confrontando una dose di 162,5 mg di polvere di aspirina sublinguale con l'aspirina orale convenzionale. L'endpoint primario si concentra sulla concentrazione plasmatica di acido acetilsalicilico nelle 24 ore.
L'azienda prevede di richiedere un incontro pre-IND con la FDA nel secondo trimestre del 2025 per discutere i piani di sviluppo per una presentazione NDA 505(b)(2). Il prodotto mira a trattare l'infarto miocardico acuto sospetto, con potenziali benefici tra cui assorbimento rapido, migliorata biodisponibilità e ridotto irritazione gastrica. I dati clinici iniziali sono attesi entro la fine del secondo trimestre.
Aspire Biopharma Holdings (NASDAQ:ASBP) ha iniciado un ensayo clínico de Fase 1 para su formulación de aspirina de alta dosis de acción rápida por vía transmucosa oral. El estudio, que se llevará a cabo en un solo centro, evaluará la seguridad, la farmacocinética y la farmacodinamia de su polvo de aspirina sublingual.
El ensayo inscribirá de 6 a 8 participantes en abril de 2025, comparando una dosis de 162,5 mg de polvo de aspirina sublingual con la aspirina oral convencional. El resultado primario se centra en la concentración plasmática de ácido acetilsalicílico durante 24 horas.
La empresa planea solicitar una reunión pre-IND con la FDA en el segundo trimestre de 2025 para discutir los planes de desarrollo para una presentación NDA 505(b)(2). El producto tiene como objetivo tratar el infarto agudo de miocardio sospechado, con beneficios potenciales que incluyen una rápida absorción, mejor biodisponibilidad y menor irritación gástrica. Se esperan datos clínicos iniciales para finales del segundo trimestre.
Aspire Biopharma Holdings (NASDAQ:ASBP)는 경구 점막을 통한 고용량 아스피린 제형의 1상 임상 시험을 시작했습니다. 이 단일 센터 연구는 그들의 설하 아스피린 분말의 안전성, 약리학적 동태 및 약리 작용을 평가할 것입니다.
이번 시험은 2025년 4월에 6-8명의 참가자를 모집하며, 162.5mg의 설하 아스피린 분말 용량을 기존 경구 아스피린과 비교합니다. 주요 결과 지표는 24시간 동안의 혈장 아세틸살리실산 농도에 초점을 맞춥니다.
회사는 2025년 2분기에 FDA와의 사전 IND 회의를 요청할 계획이며, 505(b)(2) NDA 제출을 위한 개발 계획을 논의할 것입니다. 이 제품은 의심되는 급성 심근경색을 치료하는 것을 목표로 하며, 빠른 흡수, 향상된 생체이용률 및 감소된 위장 자극과 같은 잠재적 이점을 포함합니다. 초기 임상 데이터는 2분기 말까지 예상됩니다.
Aspire Biopharma Holdings (NASDAQ:ASBP) a lancé un essai clinique de phase 1 pour sa formulation d'aspirine à forte dose à action rapide par voie transmucosale orale. L'étude, réalisée dans un seul centre, évaluera la sécurité, la pharmacocinétique et la pharmacodynamie de leur poudre d'aspirine sublinguale.
L'essai recrutera 6 à 8 participants en avril 2025, comparant une dose de 162,5 mg de poudre d'aspirine sublinguale à l'aspirine orale conventionnelle. Le critère principal de l'étude se concentre sur la concentration plasmatique d'acide acétylsalicylique sur 24 heures.
L'entreprise prévoit de demander une réunion pré-IND avec la FDA au deuxième trimestre de 2025 pour discuter des plans de développement pour une soumission NDA 505(b)(2). Le produit vise à traiter un infarctus du myocarde aigu suspecté, avec des avantages potentiels tels qu'une absorption rapide, une biodisponibilité améliorée et une irritation gastrique réduite. Les premières données cliniques sont attendues d'ici la fin du deuxième trimestre.
Aspire Biopharma Holdings (NASDAQ:ASBP) hat eine Phase-1-Studie für ihre hochdosierte, schnell wirkende orale transmukosale Aspirin-Formulierung gestartet. Die Studie an einem einzigen Standort wird die Sicherheit, Pharmakokinetik und Pharmakodynamik ihres sublingualen Aspirinpulvers bewerten.
Die Studie wird im April 2025 6-8 Teilnehmer einschließen und eine Dosis von 162,5 mg sublingualem Aspirinpulver mit herkömmlichem oralen Aspirin vergleichen. Der primäre Endpunkt konzentriert sich auf die Plasmakonzentration von Acetylsalicylsäure über 24 Stunden.
Das Unternehmen plant, im 2. Quartal 2025 ein vorläufiges IND-Meeting bei der FDA zu beantragen, um die Entwicklungspläne für eine 505(b)(2) NDA-Einreichung zu besprechen. Das Produkt zielt darauf ab, einen vermuteten akuten Myokardinfarkt zu behandeln, mit potenziellen Vorteilen wie schneller Absorption, verbesserter Bioverfügbarkeit und reduzierter Magenreizung. Erste klinische Daten werden bis Ende des 2. Quartals erwartet.
- Phase 1 clinical trial initiated with clear timeline and objectives
- Product targets acute myocardial infarction market with proven 23% mortality reduction potential
- Novel delivery method potentially offers improved bioavailability and reduced side effects
- Clear regulatory pathway via 505(b)(2) NDA submission
- Small trial size of only 6-8 participants
- Early-stage development with no revenue generation
- Success dependent on meeting FDA requirements and future trial results
Insights
Aspire Biopharma's initiation of a Phase 1 clinical trial for its sublingual high-dose aspirin represents an early-stage milestone in the company's development pipeline. The extremely small study size (6-8 participants) and single-site design characterize this as a preliminary pharmacokinetic/pharmacodynamic investigation rather than an efficacy trial.
This Phase 1 trial focuses on basic parameters: comparing plasma concentration profiles between their sublingual formulation versus standard oral aspirin. The 505(b)(2) regulatory pathway they're pursuing is appropriate for reformulations of established compounds, potentially offering a streamlined approval process if successful.
Their sublingual delivery approach aims to address two key limitations of conventional aspirin: absorption speed and gastrointestinal side effects. For acute myocardial infarction (heart attack) patients, faster platelet inhibition could theoretically improve outcomes, as referenced by the cited 23
However, investors should recognize several key factors: 1) This represents the earliest clinical stage with minimal participants; 2) The company plans to seek FDA guidance after this small study; and 3) Meaningful revenue remains years away even if development proceeds optimally. The promised Q2 data readout will provide initial pharmacokinetic insights but won't yet demonstrate clinical superiority.
The clinical significance of Aspire's sublingual aspirin approach warrants careful consideration. In acute myocardial infarction (AMI) treatment, the "time is muscle" principle means faster drug absorption could theoretically improve outcomes. Traditional oral aspirin, while effective, encounters first-pass metabolism that delays peak blood concentrations.
Their transmucosal delivery mechanism bypasses hepatic first-pass metabolism, potentially achieving faster platelet inhibition. The cited ISIS-2 trial demonstrated aspirin's 23
However, several clinical questions remain unanswered by this early-stage study: 1) Will faster absorption translate to meaningfully improved platelet inhibition? 2) How significant will the time advantage be in real-world scenarios? 3) Will reduced GI exposure actually lower bleeding complications?
The primary endpoint of plasma acetylsalicylic acid concentration will provide pharmacokinetic data but not answer these clinical questions directly. While the scientific rationale is sound, the true clinical benefit remains speculative until larger trials with clinical endpoints are conducted. The upcoming data will establish proof-of-concept for their delivery approach but represents just the first step in demonstrating clinical utility.
One clinical trial site activated
Patient enrollment expected in April
Trial designed to evaluate safety, pharmacokinetics and pharmacodynamics, of Aspire's sublingual aspirin product
Aspire anticipates releasing initial clinical data from trial at the end of the second quarter
Aspire intends to request "fast track" approval on FDA application for its high-dose aspirin product
HUMACAO, PR AND NEW YORK, NY / ACCESS Newswire / April 9, 2025 / Aspire Biopharma Holdings, Inc. (NASDAQ:ASBP) ("Aspire" or the "Company"), a developer of a multi-faceted patent-pending drug delivery technology, today announced initiation of its Phase 1 single- center clinical study of its lead therapeutic candidate, an oral transmucosal fast-acting high-dose aspirin formulation.
One clinical trial site has been activated with patient enrollment expected to total six to eight participants and begin during April.
Phase 1 Study Design
The objectives of this Phase 1 single dose clinical study are to evaluate the safety, pharmacokinetics and pharmacodynamics of Aspire's sublingual aspirin powder when administered orally in healthy adult volunteers. The Phase 1 clinical trial, which is being conducted in the United States, will compare the pharmacokinetic and pharmacodynamic characteristics of normal healthy adult volunteers administered a sublingual dose of 162.5 mg aspirin powder with control healthy subjects given 162.5 mg oral aspirin (approximately two 81 mg aspirin tablets). The primary outcome measure will be plasma acetylsalicylic acid (ASA) concentration versus time data (pre-dose and up to 24 hours post dose.)
This Phase 1 trial is expected to provide information required to select the optimal drug product formulation and inform the design of a second clinical trial, if needed, to support FDA approval. Following completion of this trial, Aspire plans to request a pre-IND meeting with the FDA in the second quarter of 2025 to finalize plans for continued development of high-dose aspirin leading to submission of a section 505(b)(2) NDA seeking approval to market the product for treatment of suspected acute myocardial infarction. An oral transmucosal acetylsalicylic acid (OTASA) product associated with rapid absorption and antiplatelet effects could provide important benefits for patients experiencing acute myocardial infarction where the benefits of aspirin in reducing the risk of vascular mortality are widely recognized and where every minute counts. In a large, multicenter study of aspirin, streptokinase, and the combination of aspirin and streptokinase in 17,187 patients with suspected acute MI, aspirin treatment produced a 23 percent reduction in the risk of vascular mortality. Aspirin was also shown to have an additional benefit in patients given a thrombolytic agent. (Source: https://pubmed.ncbi.nlm.nih.gov/2903874/ )
Greater bioavailability of ASA, through the oral mucosa (avoiding first pass metabolism) could also potentially improve pharmacodynamic effects of aspirin for patients on repeated-dose aspirin regimens while limiting the potential for direct irritation to the gastric mucosa that could be associated with gastric bleeding.
"Initiation of this trial represents a critical step toward establishing additional clinical evidence for our novel therapeutic approach of targeted, rapid sublingual delivery of high dose aspirin directly to the bloodstream, which we believe could lead to better outcomes for patients," said Kraig Higginson, Chief Executive Officer of Aspire. "Direct delivery to the bloodstream and bypassing the gastrointestinal tract with our high dose aspirin product has potential for improved efficacy driven by more rapid absorption, while reducing or eliminating adverse reactions in the gastrointestinal tract for patients."
Higginson continued, "By evaluating the time to peak concentration of our aspirin formulation in this phase 1 trial, we expect to receive important insight into the pharmacokinetic and pharmacodynamic effects of our high dose sublingual aspirin, in addition to safety data. We anticipate faster absorption and increased drug levels when compared with conventional oral aspirin. We look forward to sharing preliminary data from the study towards the end of the second quarter."
About High Dose Sublingual Aspirin
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 much earlier in the "golden hour" where intervention can save lives, allow high dose absorption for pain management including fast headache relief, post-surgery, cancer pain management, and general pain relief.
About the Aspire Targeted Oral Delivery Platform
Aspire's technology delivers a soluble, fast acting granular or powder form drug formulation which has been developed by using our patent-pending methodology, and "trade secret" process. The technologies new mechanism of action allows for rapid sublingual absorption and entry into the bloodstream. 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.
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
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SOURCE: Aspire Biopharma Holdings, Inc.
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