Ensysce Biosciences Accelerates PF614-MPAR-102 Study with Full Enrollment of Part 2
Ensysce Biosciences (NASDAQ:ENSC) has announced full enrollment of Part 2 in their PF614-MPAR-102 clinical study, focusing on evaluating food effects on their MPAR overdose protection technology. The study is supported by a three-year NIDA grant extending through May 2027.
PF614-MPAR, which has received FDA Breakthrough Therapy designation, combines Ensysce's proprietary TAAP™ and MPAR® technologies to provide pain relief with built-in overdose protection. The technology is designed to maintain therapeutic efficacy while preventing overdose when doses exceed prescribed amounts.
Ensysce Biosciences (NASDAQ:ENSC) ha annunciato il completamento dell'arruolamento per la Parte 2 del loro studio clinico PF614-MPAR-102, focalizzato sulla valutazione degli effetti del cibo sulla loro tecnologia di protezione contro l'overdose MPAR. Lo studio è supportato da un finanziamento triennale NIDA che si estende fino a maggio 2027.
PF614-MPAR, che ha ottenuto la designazione FDA Breakthrough Therapy, combina le tecnologie esclusive TAAP™ e MPAR® di Ensysce per offrire sollievo dal dolore con una protezione integrata contro l'overdose. La tecnologia è progettata per mantenere l'efficacia terapeutica prevenendo l'overdose quando le dosi superano quelle prescritte.
Ensysce Biosciences (NASDAQ:ENSC) ha anunciado la inscripción completa de la Parte 2 en su estudio clínico PF614-MPAR-102, centrado en evaluar los efectos de los alimentos sobre su tecnología de protección contra sobredosis MPAR. El estudio cuenta con el apoyo de una subvención trianual de NIDA que se extiende hasta mayo de 2027.
PF614-MPAR, que ha recibido la designación de Terapia Innovadora por la FDA, combina las tecnologías patentadas TAAP™ y MPAR® de Ensysce para proporcionar alivio del dolor con protección incorporada contra sobredosis. La tecnología está diseñada para mantener la eficacia terapéutica mientras previene la sobredosis cuando las dosis exceden las prescritas.
Ensysce Biosciences (NASDAQ:ENSC)는 MPAR 과다복용 방지 기술에 대한 음식물 영향 평가를 중심으로 한 PF614-MPAR-102 임상 연구 2단계의 전체 등록 완료를 발표했습니다. 이 연구는 2027년 5월까지 연장된 3년간 NIDA 보조금의 지원을 받고 있습니다.
FDA 혁신 치료 지정(Breakthrough Therapy designation)을 받은 PF614-MPAR는 Ensysce의 독자적인 TAAP™ 및 MPAR® 기술을 결합하여 과다복용 방지 기능이 내장된 통증 완화를 제공합니다. 이 기술은 처방된 용량을 초과할 경우에도 치료 효과를 유지하면서 과다복용을 방지하도록 설계되었습니다.
Ensysce Biosciences (NASDAQ:ENSC) a annoncé le recrutement complet de la Partie 2 de leur étude clinique PF614-MPAR-102, axée sur l'évaluation des effets alimentaires sur leur technologie de protection contre les surdoses MPAR. L'étude bénéficie d'une subvention NIDA de trois ans s'étendant jusqu'en mai 2027.
PF614-MPAR, qui a reçu la désignation de thérapie révolutionnaire par la FDA, combine les technologies propriétaires TAAP™ et MPAR® d'Ensysce pour offrir un soulagement de la douleur avec une protection intégrée contre les surdoses. Cette technologie est conçue pour maintenir l'efficacité thérapeutique tout en empêchant la surdose lorsque les doses dépassent celles prescrites.
Ensysce Biosciences (NASDAQ:ENSC) hat die vollständige Einschreibung für Teil 2 ihrer klinischen Studie PF614-MPAR-102 bekannt gegeben, die sich auf die Bewertung der Nahrungsmittelwirkungen auf ihre MPAR-Überdosisschutztechnologie konzentriert. Die Studie wird durch einen drei Jahre laufenden NIDA-Zuschuss bis Mai 2027 unterstützt.
PF614-MPAR, das die FDA Breakthrough Therapy-Auszeichnung erhalten hat, kombiniert Ensysces proprietäre TAAP™- und MPAR®-Technologien, um Schmerzlinderung mit integriertem Überdosisschutz zu bieten. Die Technologie ist darauf ausgelegt, die therapeutische Wirksamkeit aufrechtzuerhalten und gleichzeitig eine Überdosierung zu verhindern, wenn die Dosierung die verschriebene Menge überschreitet.
- Received FDA Breakthrough Therapy designation for PF614-MPAR
- Secured three-year NIDA grant funding through May 2027
- Successfully completed enrollment for Part 2 of clinical study
- Developed proprietary TAAP™ and MPAR® technologies for overdose protection
- None.
Insights
Ensysce's enrollment milestone advances unique overdose-protected opioid technology with FDA Breakthrough status and continued NIDA funding.
Ensysce has reached a significant clinical development milestone with the completed enrollment of Part 2 in their PF614-MPAR-102 study, specifically designed to evaluate how food affects their proprietary overdose protection technology. This progress represents important momentum for their lead candidate that has secured FDA Breakthrough Therapy designation - a status reserved for treatments addressing serious conditions with preliminary evidence indicating substantial improvement over available therapies.
What distinguishes PF614-MPAR is its dual-platform approach combining TAAP™ (Trypsin-Activated Abuse Protection) with MPAR® (Multi-Pill Abuse Resistance) technologies. This creates a mechanism where the drug maintains therapeutic pain relief while simultaneously offering built-in safeguards against overdose when taken in excessive quantities. In the current landscape of opioid medications, this represents a potentially transformative approach to the persistent challenge of overdose risk.
The continued financial backing from the National Institute on Drug Abuse (NIDA) through
The study's three-part design suggests a methodical approach to establishing the technology's effectiveness, with this food effect component being critical to understanding how the overdose protection mechanism performs under real-world conditions. If successful, PF614-MPAR could represent a significant competitive advantage in the pain management market, where safety concerns continue to limit existing options.
~ Treatment to Evaluate Effect of Food on Overdose Protection of MPAR ~
~ Grant Funds from NIDA Accelerating Clinical Development Program ~
SAN DIEGO, CALIFORNIA / ACCESS Newswire / June 24, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today announced it has fully enrolled Part 2 of the critical three-part PF614-MPAR-102 clinical study to study the effect of food on the MPAR technology.
PF614-MPAR has earned the FDA's prestigious Breakthrough Therapy designation and is uniquely engineered using Ensysce's proprietary TAAP™ (Trypsin-Activated Abuse Protection) and MPAR® (Multi-Pill Abuse Resistance) technologies. These platforms enable PF614-MPAR to maintain therapeutic efficacy while delivering built-in overdose protection when doses exceed prescribed amounts, whether accidentally or intentionally.
A three-year grant from the National Institute on Drug Abuse (NIDA), with second year funding recently announced1, continues to support this program through May 2027. This support will accelerate the clinical development of PF614-MPAR and could help launch a new era in pain relief with overdose protection.
"This is more than a study milestone - it's a turning point in pain medicine," said Dr. Lynn Kirkpatrick, CEO of Ensysce. "We are moving closer to delivering a new class of opioid that not only relieves pain but also shields patients from the danger of overdose. We believe PF614-MPAR has the potential to redefine opioid safety for millions of patients."
1The research is supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number UO1DA059791.
About Ensysce Biosciences
Ensysce Biosciences is a clinical stage company with a goal of disrupting the analgesic landscape by introducing a new class of highly novel opioids for the treatment of severe pain. Leveraging its Trypsin-Activated Abuse Protection (TAAPTM) and Multi-Pill Abuse Resistance (MPAR®) platforms, the Company is developing unique, tamper-proof treatment options for pain that minimize the risk of both drug abuse and overdose. Ensysce's products are anticipated to provide safer options to treat patients suffering from severe pain and assist in preventing deaths caused by medication abuse. For more information, please visit www.ensysce.com.
Forward-Looking Statements
Statements contained in this press release that are not purely historical may be deemed to be forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Without limiting the foregoing, the use of words such as "may," "intends," "can," "might," "will," "expect," "plan," "possible," "believe" and other similar expressions are intended to identify forward-looking statements. The product candidates discussed are in clinic and not approved and there can be no assurance that the clinical programs will be successful in demonstrating safety and/or efficacy, that Ensysce will not encounter problems or delays in clinical development, or that any product candidate will ever receive regulatory approval or be successfully commercialized. All forward-looking statements are based on estimates and assumptions by Ensysce's management that, although Ensysce believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Ensysce expected. In addition, Ensysce's business is subject to additional risks and uncertainties, including among others, the initiation and conduct of preclinical studies and clinical trials; the timing and availability of data from preclinical studies and clinical trials; expectations for regulatory submissions and approvals; potential safety concerns related to, or efficacy of, Ensysce's product candidates; the availability or commercial potential of product candidates; the ability of Ensysce to fund its continued operations, including its planned clinical trials; the dilutive effect of stock issuances from our fundraising; and Ensysce's and its partners' ability to perform under their license, collaboration and manufacturing arrangements. These statements are also subject to a number of material risks and uncertainties that are described in Ensysce's most recent quarterly report on Form 10-Q and current reports on Form 8-K, which are available, free of charge, at the SEC's website at www.sec.gov. Any forward-looking statement speaks only as of the date on which it was made. Ensysce undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required under applicable law.
Ensysce Biosciences Company Contact:
Lynn Kirkpatrick, Ph.D.
Chief Executive Officer
(858) 263-4196
Ensysce Biosciences Investor Relations Contact:
Shannon Devine
MZ North America
Main: 203-741-8811
ENSC@mzgroup.us
SOURCE: Ensysce Biosciences Inc.
View the original press release on ACCESS Newswire
FAQ
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