Ensysce Biosciences Announces Positive Interim Data for Breakthrough Therapy PF614-MPAR
Ensysce Biosciences (NASDAQ:ENSC) announced positive interim data from its Phase 1b clinical trial (PF614-MPAR-102) evaluating PF614-MPAR for overdose protection. The study demonstrated that the 100 mg dosage form provides significant overdose protection when taken in greater-than-prescribed doses.
The trial showed subjects receiving the MPAR product had a significantly lower (p=0.0019) total maximum blood concentration of oxycodone compared to PF614 alone. At single 100 mg doses, both formulations showed no difference in Cmax values (p=0.523), with no unexpected adverse events reported.
The study follows PF614-MPAR's FDA Breakthrough Therapy designation in 2024 and a $14 million multi-year NIDA award. The trial will continue with final cohorts in Part 1, followed by food effect studies in Part 2, and repeat dosing evaluation in Part 3.
Ensysce Biosciences (NASDAQ:ENSC) ha annunciato dati positivi intermedi dal suo studio clinico di Fase 1b (PF614-MPAR-102) che valuta PF614-MPAR per la protezione contro le sovradosi. Lo studio ha dimostrato che la formulazione da 100 mg fornisce una protezione significativa contro le sovradosi quando assunta in dosi superiori a quelle prescritte.
La sperimentazione ha mostrato che i soggetti che hanno ricevuto il prodotto MPAR avevano una concentrazione massima totale di ossicodone nel sangue significativamente più bassa (p=0.0019) rispetto a PF614 da solo. Con dosi singole da 100 mg, entrambe le formulazioni non hanno mostrato differenze nei valori di Cmax (p=0.523), senza segnalazione di eventi avversi inaspettati.
Lo studio segue la designazione di Terapia Innovativa da parte della FDA per PF614-MPAR nel 2024 e un premio multi-annuale di 14 milioni di dollari da NIDA. La sperimentazione continuerà con le coorti finali nella Parte 1, seguita da studi sull'effetto del cibo nella Parte 2, e valutazione delle dosi ripetute nella Parte 3.
Ensysce Biosciences (NASDAQ:ENSC) anunció datos interinos positivos de su ensayo clínico de Fase 1b (PF614-MPAR-102) que evalúa PF614-MPAR para la protección contra sobredosis. El estudio demostró que la formulación de 100 mg proporciona una protección significativa contra sobredosis cuando se toma en dosis superiores a las recomendadas.
El ensayo mostró que los sujetos que recibieron el producto MPAR tuvieron una concentración máxima total de oxicodona en sangre significativamente más baja (p=0.0019) en comparación con PF614 solo. A dosis únicas de 100 mg, ambas formulaciones no mostraron diferencia en los valores de Cmax (p=0.523), sin que se reportaran eventos adversos inesperados.
El estudio sigue a la designación de Terapia Innovadora de la FDA para PF614-MPAR en 2024 y un premio de 14 millones de dólares de NIDA a varios años. El ensayo continuará con las cohortes finales en la Parte 1, seguido de estudios del efecto de los alimentos en la Parte 2, y evaluación de dosis repetidas en la Parte 3.
Ensysce Biosciences (NASDAQ:ENSC)는 PF614-MPAR의 과다복용 방지를 평가하는 임상 시험 1b 단계(PF614-MPAR-102)에서 긍정적인 중간 데이터를 발표했습니다. 연구 결과, 100mg 제형이 권장 용량 이상으로 복용했을 때 유의미한 과다복용 보호 효과를 제공함을 보여주었습니다.
시험 결과, MPAR 제품을 받은 피험자들은 PF614 단독 투여군에 비해 총 최대 옥시코돈 혈중 농도가 유의미하게 낮았으며(p=0.0019), 100mg의 단일 용량에서 두 제형 모두 Cmax 값에 차이를 보이지 않았습니다(p=0.523). 예기치 않은 부작용도 보고되지 않았습니다.
이 연구는 PF614-MPAR가 2024년에 FDA 혁신 치료제 지정을 받은 것과 1400만 달러의 다년간 NIDA 상을 수주한 이후 진행됩니다. 시험은 1부의 최종 집단을 포함하여 계속 진행되며, 2부에서는 음식의 영향을 연구하고, 3부에서는 반복 투여 평가를 실시합니다.
Ensysce Biosciences (NASDAQ:ENSC) a annoncé des données intermédiaires positives provenant de son essai clinique de phase 1b (PF614-MPAR-102) évaluant PF614-MPAR pour la protection contre les overdoses. L'étude a montré que la formulation de 100 mg fournit une protection significative contre les overdoses lorsqu'elle est prise à des doses supérieures à celles prescrites.
L'essai a montré que les sujets recevant le produit MPAR avaient une concentration maximale totale d'oxycodone dans le sang significativement plus basse (p=0.0019) par rapport à PF614 seul. À des doses uniques de 100 mg, les deux formulations n'ont montré aucune différence dans les valeurs de Cmax (p=0.523), sans événements indésirables inattendus signalés.
L'étude fait suite à la décision de la FDA sur la thérapie innovante pour PF614-MPAR en 2024 et à une subvention de 14 millions de dollars de NIDA sur plusieurs années. L'essai se poursuivra avec les cohortes finales dans la partie 1, suivi d'études sur l'effet de la nourriture dans la partie 2, et d'évaluation de doses répétées dans la partie 3.
Ensysce Biosciences (NASDAQ:ENSC) gab positive Zwischenresultate aus seiner klinischen Phase 1b-Studie (PF614-MPAR-102) bekannt, die PF614-MPAR zum Schutz bei Überdosierung bewertet. Die Studie zeigte, dass die 100 mg-Dosierung einen signifikanten Schutz vor Überdosierungen bietet, wenn sie in höheren als vorgeschriebenen Dosen eingenommen wird.
Die Studie zeigte, dass Probanden, die das MPAR-Produkt erhielten, eine signifikant niedrigere (p=0.0019) maximale Blutkonzentration von Oxycodon hatten im Vergleich zu PF614 allein. Bei einzelnen Dosen von 100 mg zeigten beide Formulierungen keinen Unterschied in den Cmax-Werten (p=0.523), und es wurden keine unerwarteten unerwünschten Ereignisse berichtet.
Die Studie folgt der FDA-Designierung als Durchbruchtherapie für PF614-MPAR im Jahr 2024 und einem NIDA-Zuschuss über 14 Millionen Dollar für mehrere Jahre. Die Studie wird mit den letzten Kohorten in Teil 1 fortgesetzt, gefolgt von Studien zu den Ernährungseffekten in Teil 2 und einer Evaluierung der Wiederholung Dosen in Teil 3.
- Received FDA Breakthrough Therapy designation in 2024
- Secured $14 million multi-year NIDA award
- Demonstrated significant overdose protection in clinical trials (p=0.0019)
- No unexpected adverse events reported in safety data
- None.
Insights
Ensysce Biosciences has achieved a significant milestone in developing a potentially revolutionary pain medication. Their drug candidate PF614-MPAR has shown promising interim results in a Phase 1b clinical trial, demonstrating a important safety feature: it works normally when taken as prescribed but actively prevents overdose effects when taken in excess.
To break this down simply: Imagine a car with a built-in speed governor that only activates when someone tries to drive dangerously fast, but doesn't affect normal driving. Similarly, PF614-MPAR allows normal pain relief at prescribed doses but automatically limits opioid levels in the blood when someone takes too much.
The data is particularly compelling: When subjects took multiple doses at once, they showed significantly lower peak oxycodone levels (p=0.0019) compared to the control version, indicating effective overdose protection. Yet importantly, when taken as prescribed, the drug showed equivalent effectiveness (p=0.523) to standard treatment.
This development carries substantial weight in the pharmaceutical industry for several reasons:
- It's the first opioid to receive FDA Breakthrough Therapy designation, potentially accelerating its path to market
- The $14 million NIDA funding validates the technology's potential impact on public health
- The successful interim results support advancement toward commercialization
The company is now moving forward with food effect studies and extended dosing evaluations, important steps before potential FDA approval. With over 80,000 opioid overdose deaths annually in the U.S., a safer opioid option could represent a significant advance in pain management while addressing a critical public health crisis.
~ Positive Phase 1b Data Confirms Overdose Protection for Highest Dosage Form of PF614-MPAR ~
SAN DIEGO, CA / ACCESS Newswire / January 22, 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 interim data from its second clinical trial to evaluate PF614-MPAR for overdose protection. Clinical study PF614-MPAR-102, ‘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 of Immediate Release Solution and Extended Release Capsule Formulations (PF614-MPAR) in Healthy Subjects,' was designed to evaluate the full dosage range of PF614-MPAR, study potential food effects, and to conduct a multiple ascending dose study with the final PF614-MPAR combination. In 2024, PF614-MPAR received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA), and had its development bolstered by a
The PF614-MPAR-102 study showed that a 100 mg dosage form of PF614-MPAR provides overdose protection when a greater-than-prescribed dose is consumed at one time. Subjects were studied as their own control and received three doses of the overdose-protected PF614-MPAR versus PF614. The subjects receiving the MPAR product had a significantly lower (p=0.0019) total maximum blood concentration of oxycodone (Cmax) compared to PF614 alone, an indication of overdose protection. As designed, subjects who received a single 100 mg dose of PF614 or PF614 MPAR showed no difference in Cmax values (p=0.523). Additionally, safety data from the trial showed that there were no unexpected adverse events from either PF614 or PF614-MPAR. The trial will now continue to enroll the final cohorts of Part 1 of the study and then move to Part 2, which is designed to examine potential food effects. Part 3 will then evaluate repeat dosing of PF614 vs. PF614-MPAR over 4.5 days. The aggregation of interim data allows the Company to focus on perfecting a final drug product to move to commercialization.
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's Breakthrough Therapy designation, a first for an opioid drug product. This second study builds on the initial data and further demonstrates that MPAR is a vital tool to limit unwanted overdoses from prescription medications. Our goal of bringing PF614-MPAR and a new generation of safer analgesics to the market to alleviate suffering from severe pain is being realized."
Dr. Lynn Kirkpatrick, CEO of Ensysce, added, "We are delighted with the positive early interim data which confirms that MPAR provides overdose protection in the planned dosage range for our PF614-MPAR drug product. We will continue to quickly execute the final stages of this study using the Translational Pharmaceutics® platform of Quotient Sciences in advance of our work with our new commercial manufacturing partner to prepare this very unique product for the market. 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."
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 ACCESS Newswire
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