Ensysce Biosciences Completes Significant Milestone, Dosing First Subjects in Breakthrough Therapy PF614-MPAR Trial
Ensysce Biosciences (NASDAQ:ENSC) has initiated dosing in the PF614-MPAR-102 study, marking a significant milestone for its breakthrough therapy-designated opioid drug. The trial aims to evaluate the pharmacokinetics of oxycodone and PF614 when co-administered with nafamostat. The study received a $14 million multi-year award from NIDA and expects early interim data in Q1 2025. The three-part trial will assess the full dosage range, food effects, and conduct multi-ascending dose studies of PF614-MPAR, which is designed to reduce deliberate and accidental overdoses in severe pain treatment.
Ensysce Biosciences (NASDAQ:ENSC) ha avviato la somministrazione nello studio PF614-MPAR-102, segnando un traguardo significativo per il suo farmaco oppioide designato come terapia innovativa. La sperimentazione mira a valutare la farmacocinetica dell'ossicodone e del PF614 quando somministrati insieme al nafamostat. Lo studio ha ricevuto un premio di 14 milioni di dollari da NIDA per pluriennale e si aspetta dati preliminari entro il primo trimestre del 2025. La sperimentazione in tre parti valuterà l'intera gamma di dosaggio, gli effetti del cibo e condurrà studi di dose crescente multipla del PF614-MPAR, progettato per ridurre le overdose deliberate e accidentali nel trattamento del dolore severo.
Ensysce Biosciences (NASDAQ:ENSC) ha iniciado la dosificación en el estudio PF614-MPAR-102, marcando un hito significativo para su medicamento opioide designado como terapia innovadora. La prueba tiene como objetivo evaluar la farmacocinética de la oxicodona y PF614 cuando se administran conjuntamente con nafamostat. El estudio recibió un premio de 14 millones de dólares de NIDA y espera datos interinos tempranos en el primer trimestre de 2025. El ensayo de tres partes evaluará todo el rango de dosis, los efectos de los alimentos y realizará estudios de dosis en ascenso múltiple del PF614-MPAR, diseñado para reducir las sobredosis deliberadas y accidentales en el tratamiento del dolor severo.
Ensysce Biosciences (NASDAQ:ENSC)는 PF614-MPAR-102 연구에서 첫 번째 투여를 시작했으며, 이는 혁신적 치료제로 지정된 오피오이드 약물의 중요한 이정표가 됩니다. 이 시험은 나파모스타트와 함께 병용 투여될 때 옥시코돈과 PF614의 약리학적 작용을 평가하는 것을 목표로 합니다. 이 연구는 NIDA로부터 1400만 달러의 다년간 지원을 받았으며, 2025년 1분기에 초기 중간 데이터를 기대하고 있습니다. 세 부분으로 나눠 진행되는 이 시험은 전체 복용량 범위, 음식 효과를 평가하고 PF614-MPAR의 다중 상승 용량 연구를 수행할 예정이며, 이는 중증 통증 치료에서 의도적 및 우발적 과다 복용을 줄이도록 설계되었습니다.
Ensysce Biosciences (NASDAQ:ENSC) a initié la distribution dans l'étude PF614-MPAR-102, marquant une étape significative pour son médicament opioïde désigné comme thérapie novatrice. L'essai vise à évaluer la pharmacocinétique de l'oxycodone et du PF614 lorsqu'ils sont administrés conjointement avec le nafamostat. L'étude a reçu un financement de 14 millions de dollars de NIDA et prévoit des données préliminaires dès le premier trimestre de 2025. L'essai en trois parties évaluera l'ensemble de la plage de dosage, les effets des aliments et effectuera des études de doses ascendantes multiples du PF614-MPAR, qui est conçu pour réduire les overdoses intentionnelles et accidentelles dans le traitement de la douleur sévère.
Ensysce Biosciences (NASDAQ:ENSC) hat die Verabreichung in der PF614-MPAR-102-Studie eingeleitet, was einen bedeutenden Meilenstein für sein mit einem Durchbruch therapierten opioid Medikament darstellt. Die Studie zielt darauf ab, die Pharmakokinetik von Oxycodon und PF614 bei gleichzeitiger Verabreichung mit Nafamostat zu bewerten. Die Studie erhielt eine Auszeichnung in Höhe von 14 Millionen Dollar von NIDA und erwartet erste Zwischenresultate im 1. Quartal 2025. Die dreiteilige Studie wird den gesamten Dosierungsbereich, die Auswirkungen von Nahrungsmitteln und die Durchführung von Mehrdosensteigerungsstudien mit PF614-MPAR bewerten, das darauf ausgelegt ist, absichtliche und unbeabsichtigte Überdosen in der Behandlung von schweren Schmerzen zu reduzieren.
- Received FDA Breakthrough Therapy designation for PF614-MPAR
- Secured $14 million multi-year funding from NIDA
- Successfully initiated first subject dosing in PF614-MPAR-102 study
- None.
Insights
This clinical trial milestone represents a significant advancement in Ensysce's development of PF614-MPAR, their breakthrough therapy for pain management with built-in overdose protection. The
The trial's design is comprehensive, examining pharmacokinetics across multiple dosing scenarios and formulations. The inclusion of nafamostat as part of the combination therapy is particularly noteworthy, as it's integral to the overdose protection mechanism. Interim data expected in Q1 2025 will be important in validating the safety profile and efficacy of this novel approach.
For a micro-cap company (
~ Landmark Overdose Protection Clinical Trial of PF614-MPAR ~
~ Expects Early Interim Data in 1Q 2025 ~
SAN DIEGO, CA / ACCESSWIRE / November 26, 2024 / 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 that it has treated its first group of subjects in the PF614-MPAR-102 study. PF614-MPAR received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) and had its development bolstered by the recent
Dr. Lynn Kirkpatrick, CEO of Ensysce, was quoted, "Overdose from prescription drugs is still a major societal issue and Ensysce may have the first opioid that can reduce deliberate and accidental overdoses. My team has made this program a priority as we continue to collaborate with Quotient Sciences using their Translational Pharmaceutics® platform. We are delighted with the speed at which Quotient has executed the trial start-up activities and advanced into subject dosing as we aim to receive early interim data in the first quarter of 2025. We look forward to completing this highly important three-part trial and generating additional evidence to conduct productive discussions with the FDA on the path to registration for the first overdose-protected opioid."
Dr. Bill Schmidt, Chief Medical Officer of Ensysce, commented, "Clinical data from our initial study demonstrated the unique overdose protection built into PF614-MPAR, which led to the FDA designation of Breakthrough Therapy, a first for an opioid drug product. We believe this second study will further build on our initial data and aid in bringing PF614-MPAR and a new generation of safer analgesics to the market to alleviate suffering and bring relief to those who experience severe pain."
The trial ‘A Single and Multiple Dose Study to Evaluate the Pharmacokinetics of Oxycodone and PF614 when PF614 capsule is Co‑Administered with Nafamostat as a combination Immediate Release solution and Extended-Release Capsule Formulation in Healthy Subjects', is designed to evaluate the full dosage range of PF614-MPAR, study food effects and to conduct a multi-ascending dose study.
About Ensysce Biosciences
Ensysce Biosciences is a clinical stage company using its proprietary technology platforms to develop safer prescription drugs. 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. The platforms are covered by an extensive worldwide intellectual property portfolio for a wide array of prescription drug compositions. 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 accesswire.com
FAQ
When will Ensysce Biosciences (ENSC) release interim data for the PF614-MPAR trial?
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