Aspire Biopharma Holdings, Inc., Announces Institutional Review Board Approval for In-Human Clinical Trial of an Oral Transmucosal Fast-Acting High-Dose Aspirin Formulation
Aspire Biopharma (Nasdaq: ASBP) has received Institutional Review Board (IRB) approval for its Phase I clinical trial of a novel oral transmucosal fast-acting high-dose aspirin formulation. The trial, set to begin this week, will involve 6-8 participants at a single U.S. center.
The study will compare a 162.5 mg sublingual aspirin powder against standard oral aspirin in healthy adult volunteers, measuring plasma acetylsalicylic acid concentration over 24 hours. This innovative delivery method aims to bypass first-pass metabolism through oral mucosa absorption.
The company plans to pursue FDA fast-track approval via a 505(b)(2) NDA for treating suspected acute myocardial infarction. Previous research has shown aspirin treatment reduced vascular mortality risk by 23% in MI patients. The new formulation could potentially offer improved bioavailability while limiting gastric irritation associated with traditional aspirin delivery.
Aspire Biopharma (Nasdaq: ASBP) ha ottenuto l'approvazione del Comitato Etico (IRB) per la sua sperimentazione clinica di Fase I su una nuova formulazione orale transmucosale di aspirina ad alta dose e ad azione rapida. La sperimentazione, che inizierà questa settimana, coinvolgerà 6-8 partecipanti in un unico centro negli Stati Uniti.
Lo studio confronterà una polvere sublinguale di aspirina da 162,5 mg con l'aspirina orale standard in volontari adulti sani, misurando la concentrazione plasmatica di acido acetilsalicilico per 24 ore. Questo metodo innovativo di somministrazione mira a bypassare il metabolismo di primo passaggio attraverso l'assorbimento nella mucosa orale.
L'azienda intende richiedere l'approvazione FDA tramite la procedura fast-track con una NDA 505(b)(2) per il trattamento dell'infarto miocardico acuto sospetto. Studi precedenti hanno dimostrato che il trattamento con aspirina riduceva il rischio di mortalità vascolare del 23% nei pazienti con infarto. La nuova formulazione potrebbe offrire una migliore biodisponibilità limitando al contempo l'irritazione gastrica associata alla somministrazione tradizionale di aspirina.
Aspire Biopharma (Nasdaq: ASBP) ha recibido la aprobación del Comité de Revisión Institucional (IRB) para su ensayo clínico de Fase I de una nueva formulación oral transmucosal de aspirina de alta dosis y acción rápida. El ensayo, que comenzará esta semana, involucrará a 6-8 participantes en un solo centro en EE.UU.
El estudio comparará un polvo sublingual de aspirina de 162,5 mg con la aspirina oral estándar en voluntarios adultos sanos, midiendo la concentración plasmática de ácido acetilsalicílico durante 24 horas. Este método innovador de administración busca evitar el metabolismo de primer paso mediante la absorción en la mucosa oral.
La compañía planea solicitar la aprobación acelerada de la FDA a través de una NDA 505(b)(2) para el tratamiento del infarto agudo de miocardio sospechado. Investigaciones previas han demostrado que el tratamiento con aspirina reduce el riesgo de mortalidad vascular en un 23% en pacientes con infarto. La nueva formulación podría ofrecer mejor biodisponibilidad mientras limita la irritación gástrica asociada con la administración tradicional de aspirina.
Aspire Biopharma (나스닥: ASBP)는 새로운 고용량 빠른 작용 경구 점막 흡수 아스피린 제형에 대한 1상 임상시험에 대해 기관 심사 위원회(IRB) 승인을 받았습니다. 이번 주 시작될 이 시험은 미국 내 단일 기관에서 6-8명의 참가자를 대상으로 진행됩니다.
본 연구는 162.5mg 설하 아스피린 분말과 표준 경구 아스피린을 건강한 성인 자원자에게 투여하여 24시간 동안 혈장 아세틸살리실산 농도를 측정합니다. 이 혁신적 투여 방식은 구강 점막을 통한 흡수로 1차 통과 대사를 우회하는 것을 목표로 합니다.
회사는 의심되는 급성 심근경색증 치료를 위해 505(b)(2) NDA를 통한 FDA 신속 승인 절차를 추진할 계획입니다. 이전 연구에서는 아스피린 치료가 심근경색 환자의 혈관 사망 위험을 23% 감소시키는 것으로 나타났습니다. 새로운 제형은 기존 아스피린 투여 시 발생하는 위장 자극을 줄이면서 생체이용률을 개선할 가능성이 있습니다.
Aspire Biopharma (Nasdaq : ASBP) a obtenu l'approbation du Comité d'examen institutionnel (IRB) pour son essai clinique de phase I d'une nouvelle formulation orale transmucosale d'aspirine à haute dose et à action rapide. L'essai, qui débutera cette semaine, impliquera 6 à 8 participants dans un seul centre aux États-Unis.
L'étude comparera une poudre d'aspirine sublinguale de 162,5 mg à l'aspirine orale standard chez des volontaires adultes en bonne santé, en mesurant la concentration plasmatique en acide acétylsalicylique sur 24 heures. Cette méthode innovante vise à contourner le métabolisme de premier passage grâce à l'absorption par la muqueuse buccale.
L'entreprise prévoit de demander une approbation accélérée de la FDA via une NDA 505(b)(2) pour le traitement de l'infarctus du myocarde aigu suspecté. Des recherches antérieures ont montré que le traitement à l'aspirine réduisait le risque de mortalité vasculaire de 23 % chez les patients infarctus. La nouvelle formulation pourrait offrir une meilleure biodisponibilité tout en limitant l'irritation gastrique associée à l'administration traditionnelle de l'aspirine.
Aspire Biopharma (Nasdaq: ASBP) hat die Zulassung durch das Institutional Review Board (IRB) für seine Phase-I-Studie einer neuartigen oralen, transmukosalen, schnell wirkenden Aspirin-Formulierung in hoher Dosierung erhalten. Die Studie, die diese Woche beginnt, wird 6-8 Teilnehmer an einem einzigen US-Standort umfassen.
Die Untersuchung vergleicht ein 162,5 mg sublinguales Aspirin-Pulver mit Standard-Oralaspirin bei gesunden erwachsenen Freiwilligen und misst die Plasmakonzentration von Acetylsalicylsäure über 24 Stunden. Diese innovative Darreichungsform soll den First-Pass-Metabolismus durch Absorption über die Mundschleimhaut umgehen.
Das Unternehmen plant, eine FDA-Fast-Track-Zulassung über eine 505(b)(2) NDA für die Behandlung eines vermuteten akuten Myokardinfarkts anzustreben. Frühere Studien zeigten, dass eine Aspirin-Behandlung das Risiko vaskulärer Mortalität bei MI-Patienten um 23 % senkte. Die neue Formulierung könnte eine verbesserte Bioverfügbarkeit bieten und gleichzeitig die mit herkömmlicher Aspirin-Gabe verbundene Magenreizung reduzieren.
- IRB approval received for Phase I clinical trial of fast-acting high-dose aspirin formulation
- Clinical trial site activated with immediate trial commencement expected this week
- Potential fast-track FDA approval pathway identified through 505(b)(2) NDA
- Product targets acute myocardial infarction market where aspirin shows 23% reduction in vascular mortality risk
- Technology potentially offers improved bioavailability by avoiding first-pass metabolism
- Small initial trial size of only 6-8 participants indicates early-stage development
- Additional clinical trials may be required before FDA approval
- No revenue generation at current stage
- Competitive market for aspirin-based products
Insights
IRB approval enables Aspire's Phase I trial of fast-acting aspirin delivery, advancing clinical validation of potential emergency cardiac treatment.
Aspire Biopharma has secured Institutional Review Board approval for their Phase I clinical trial, a necessary regulatory milestone that enables the company to begin testing their oral transmucosal fast-acting high-dose aspirin formulation in human subjects. This development transitions their lead candidate from preclinical to clinical stage, with patient enrollment of 6-8 participants expected to commence this week.
The trial will evaluate three critical parameters: safety, pharmacokinetics, and pharmacodynamics of their sublingual powder formulation versus conventional oral aspirin. This comparison will determine whether their delivery technology achieves the hypothesized faster absorption profile, which could be particularly valuable in acute myocardial infarction scenarios where rapid platelet inhibition is crucial.
Aspire's 505(b)(2) regulatory strategy leverages existing safety data on aspirin while focusing on demonstrating their formulation's potential advantages. The company has identified two potential benefits: faster absorption through oral mucosa (bypassing first-pass metabolism) for emergency use and reduced gastric irritation for chronic users.
While this IRB approval represents standard procedural progress, it confirms Aspire is executing on its clinical development timeline. The small trial size is appropriate for initial pharmacokinetic assessment but will only provide preliminary evidence of their technology's potential advantages.
Aspire's IRB-approved Phase I trial will assess sublingual aspirin's pharmacokinetics for potential faster absorption in acute cardiac events.
Aspire's IRB approval enables clinical evaluation of their sublingual aspirin powder delivery system, which targets a clinically significant need: faster platelet inhibition during suspected heart attacks. The trial will compare a 162.5mg sublingual formulation against equivalent oral aspirin, with plasma concentration measurements over 24 hours as the primary endpoint.
The scientific rationale is sound: by bypassing first-pass metabolism through oral mucosal absorption, acetylsalicylic acid could potentially reach therapeutic levels faster than conventional oral administration. This timing difference could be clinically meaningful in acute myocardial infarction, where the article cites research demonstrating aspirin's 23% reduction in vascular mortality risk.
The trial design appropriately focuses on pharmacokinetics in healthy volunteers, which will establish whether the formulation achieves its primary technical objective. If successful, this data would inform subsequent studies potentially targeting two distinct applications: emergency use during suspected heart attacks and daily use for patients requiring chronic antiplatelet therapy.
The sublingual delivery mechanism may offer a secondary benefit of reduced gastric irritation by avoiding direct stomach contact, potentially addressing a common side effect of long-term aspirin therapy. However, this Phase I study focuses primarily on absorption parameters rather than clinical outcomes, representing an early but necessary step in validating the company's drug delivery technology.
Company achieves another milestone relating to its clinical trial strategy
HUMACAO, PR and NEW YORK, NY / ACCESS Newswire / April 29, 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 has received Institutional Review Board (IRB) approval of the clinical trial protocol for its upcoming Phase I single-center clinical trial in the United States designed to evaluate safety, pharmacokinetics and pharmacodynamics, 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 the trials are expected to begin this week.
"The purpose of IRB review is to assure that appropriate steps are taken to protect the rights and welfare of individuals participating as subjects in clinical research," said Kraig Higginson, Chief Executive Officer of Aspire. "With this centralized IRB approval, we have achieved another significant clinical milestone. We remain focused on completing our preparations for the clinical trial of our oral transmucosal fast-acting high-dose aspirin formulation and look forward to its commencement."
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.) More information can be found at https://clinicaltrials.gov/
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 submit a section 505(b)(2) NDA seeking fast-track 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.
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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