Ensysce Biosciences Reports Continued Positive Progress in Groundbreaking Trial on PF614-MPAR, Comments on Current Landscape for Pain Treatment
Ensysce Biosciences (NASDAQ:ENSC) reported positive progress in its clinical trial evaluating PF614-MPAR for overdose protection. The study demonstrated that a 100mg dosage provides overdose protection when consumed above prescribed amounts, with successful enrollment in the highest dosing cohort of 5x the 100mg dose unit.
The trial has shown adverse events, confirming the favorable safety profile of PF614 and PF614-MPAR as novel opioids for severe pain treatment. The FDA granted Breakthrough Therapy designation to PF614-MPAR in 2024, recognizing its unique position as an opioid with oral overdose protection.
The company believes its products will address an unmet need in severe and chronic pain management, particularly following recent FDA approval of NaV1.8 inhibitors for moderate pain treatment.
Ensysce Biosciences (NASDAQ:ENSC) ha riportato progressi positivi nel suo studio clinico che valuta PF614-MPAR per la protezione da overdose. Lo studio ha dimostrato che una dose di 100 mg offre protezione in caso di overdose quando consumata oltre i limiti prescritti, con un arruolamento di successo nel gruppo con la dose più alta di 5 volte l'unità di 100 mg.
La sperimentazione ha mostrato eventi avversi, confermando il favorevole profilo di sicurezza di PF614 e PF614-MPAR come nuovi oppioidi per il trattamento del dolore severo. La FDA ha conferito la designazione di Terapia Innovativa a PF614-MPAR nel 2024, riconoscendo la sua posizione unica come oppioide con protezione da overdose orale.
L'azienda crede che i suoi prodotti risponderanno a un bisogno insoddisfatto nella gestione del dolore severo e cronico, in particolare dopo l'approvazione recente della FDA degli inibitori di NaV1.8 per il trattamento del dolore moderato.
Ensysce Biosciences (NASDAQ:ENSC) informó avances positivos en su ensayo clínico que evalúa el PF614-MPAR para la protección contra sobredosis. El estudio demostró que una dosis de 100 mg proporciona protección contra sobredosis cuando se consume por encima de las cantidades prescritas, con un reclutamiento exitoso en el grupo de dosis más alta de 5x la unidad de 100 mg.
El ensayo ha mostrado eventos adversos, confirmando el perfil de seguridad favorable de PF614 y PF614-MPAR como nuevos opioides para el tratamiento del dolor severo. La FDA otorgó la designación de Terapia Innovadora a PF614-MPAR en 2024, reconociendo su posición única como un opioide con protección contra sobredosis oral.
La compañía cree que sus productos abordarán una necesidad no satisfecha en el manejo del dolor severo y crónico, particularmente tras la reciente aprobación de la FDA de inhibidores de NaV1.8 para el tratamiento del dolor moderado.
엔시스 바이오사이언스 (NASDAQ:ENSC)는 PF614-MPAR의 과다 복용 방지 효능을 평가하는 임상 시험에서 긍정적인 진전을 보고했습니다. 연구 결과, 100mg 용량이 처방량을 초과하여 섭취할 때 과다 복용 방지 효과를 제공하며, 100mg 단위의 5배 용량을 가진 집단에서 성공적으로 등록되었습니다.
시험 결과는 부작용을 나타냈고, PF614와 PF614-MPAR의 심각한 통증 치료를 위한 새로운 오피오이드로서의 유리한 안전성 프로필을 확인했습니다. FDA는 2024년에 PF614-MPAR에 혁신 치료제 지정을 부여하여 경구 과다 복용 방지 기능을 가진 오피오이드로서의 독특한 입지를 인식했습니다.
회사는 자사의 제품이 심각하고 만성적인 통증 관리의 unmet need를 해결할 것이라고 믿고 있으며, 특히 중간 통증 치료를 위한 NaV1.8 억제제의 최근 FDA 승인 이후에 그렇습니다.
Ensysce Biosciences (NASDAQ:ENSC) a rapporté des progrès positifs dans son essai clinique évaluant le PF614-MPAR pour la protection contre les overdoses. L'étude a démontré qu'un dosage de 100 mg offre une protection contre les overdoses lorsqu'il est consommé au-delà des quantités prescrites, avec une inscription réussie dans le groupe de dosage le plus élevé de 5x l'unité de 100 mg.
L'essai a montré des événements indésirables, confirmant le profil de sécurité favorable du PF614 et du PF614-MPAR en tant que nouveaux opioïdes pour le traitement de la douleur sévère. La FDA a accordé en 2024 la désignation de thérapie novatrice au PF614-MPAR, reconnaissant sa position unique en tant qu'opioïde avec protection contre les overdoses par voie orale.
L'entreprise croit que ses produits répondront à un besoin non satisfait dans la gestion de la douleur sévère et chronique, en particulier après l'approbation récente par la FDA des inhibiteurs de NaV1.8 pour le traitement de la douleur modérée.
Ensysce Biosciences (NASDAQ:ENSC) berichtete über positive Fortschritte in seiner klinischen Studie zur Evaluierung von PF614-MPAR zum Schutz vor Überdosierung. Die Studie zeigte, dass eine Dosierung von 100 mg Schutz vor Überdosierung bietet, wenn sie über den verschriebenen Mengen konsumiert wird, mit erfolgreicher Einschreibung in der höchsten Dosisgruppe von 5x der 100 mg Dosis.
Die Studie hat unerwünschte Ereignisse gezeigt, die das günstige Sicherheitsprofil von PF614 und PF614-MPAR als neuartige Opioide zur Behandlung von schwerem Schmerz bestätigen. Die FDA verlieh 2024 der PF614-MPAR den Status einer Durchbruchtherapie und erkannte ihre einzigartige Position als Opioid mit Mund-Überdosierungsschutz an.
Das Unternehmen ist der Meinung, dass seine Produkte ein unerfülltes Bedürfnis im Management von schwerem und chronischem Schmerz ansprechen werden, insbesondere nach der jüngsten FDA-Zulassung von NaV1.8-Hemmern zur Behandlung von mäßigen Schmerzen.
- Successful enrollment and dosing in highest cohort (5x 100mg) of PF614-MPAR trial
- adverse events reported, confirming favorable safety profile
- FDA Breakthrough Therapy designation received in 2024
- Demonstrated overdose protection across 25-100mg dosage range
- None.
Insights
The clinical trial progress for PF614-MPAR represents a significant advancement in pain management technology. The successful demonstration of overdose protection at 100mg dosage, combined with ongoing evaluation at 5x higher doses, validates the drug's core safety mechanism. The adverse events reported thus far strengthen the safety profile of both PF614 and PF614-MPAR.
The Breakthrough Therapy designation from the FDA in 2024 is particularly noteworthy, as it's typically reserved for drugs that show substantial improvement over existing therapies. This designation can accelerate the development and review process, potentially reducing time to market by several years.
The market context is evolving with the introduction of NaV1.8 inhibitors, but these primarily target moderate pain and NSAID-intolerant patients. PF614-MPAR's positioning for severe pain, combined with its unique overdose protection mechanism, addresses an entirely different market segment with significant unmet needs.
The clinical data pattern suggests a methodical development approach, with dose escalation from 25mg to 100mg demonstrating consistent overdose protection. This systematic validation across multiple dose levels strengthens the product's safety profile and potential clinical utility.
The pain management market is experiencing a strategic shift with the emergence of novel treatment options. PF614-MPAR's unique position as the only opioid with built-in overdose protection creates a compelling value proposition in the severe pain segment, where traditional opioids remain the standard of care despite their risks.
The market differentiation is particularly strong, with PF614-MPAR addressing both abuse resistance and overdose protection - two critical factors in the current opioid crisis context. While NaV1.8 inhibitors target the moderate pain segment, they effectively validate the market's appetite for innovative pain management solutions.
The successful progression through clinical trials with positive safety data significantly de-risks the commercial potential. The extensive dose range validation (25mg to 100mg) suggests flexibility in clinical applications, which could expand market reach across various pain intensity levels and patient populations.
~ Positive Enrollment Progress and Safety Data ~
~ FDA Attention Establishes Momentum in the Pain Treatment Space ~
SAN DIEGO, CA / ACCESS Newswire / February 5, 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 continued subject enrollment and successful dosing augmenting the progress of its second clinical trial to evaluate PF614-MPAR for overdose protection.
In the current study of PF614-MPAR-102, data showed that a 100 mg dosage form of PF614-MPAR provides overdose protection when a greater-than-prescribed dose is consumed at one time. The study has continued with successful enrollment of the highest dosing cohort of 5 times the 100 mg dose unit. Importantly, adverse events have been limited, thus far verifying the favorable safety profile of PF614 and PF614-MPAR as a novel class of opioids to treat severe pain. The uniqueness of PF614-MPAR, a combination opioid with oral overdose protection resulted in the FDA's Breakthrough Therapy designation in 2024.
Dr. Lynn Kirkpatrick, CEO of Ensysce, stated, "Our progress in developing the only opioid with overdose protection is encouraging and data now confirms overdose protection across a dosage range of 25 to 100 mg for our PF614-MPAR drug product. Additionally, we are optimistic about the recent regulatory attention on pain treatment, evident in the latest approval of a NaV1.8 inhibitor. This product may contribute to pain management for those individuals who cannot tolerate NSAIDs, an area that has seen little innovation over the last few decades. Based on data reported so far, we believe NaV1.8 inhibitors will be an important addition for moderate pain currently treated with NSAIDs and COX-2 analgesics. However, to effectively treat severe acute and chronic pain, our team and expert advisors believe the market for a safe opioid remains open to an innovative solution, and we believe PF614 plus PF614-MPAR will be this solution."
Dr. William Schmidt, Chief Medical Officer of Ensysce, added, "We are pleased that the FDA's approval of new products for pain is emerging in this area of high unmet need, where different patients require differing approaches. We believe the most severe and chronic pain will still require products with opioid-like efficacy. We believe we've addressed this goal with the unique value proposition of abuse resistance and overdose protection in Ensysce's lead products PF614 and PF614-MPAR."
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
View the original press release on ACCESS Newswire
FAQ
What results did Ensysce Biosciences (ENSC) report for PF614-MPAR's overdose protection trial?
What dosage range has been proven effective for ENSC's PF614-MPAR overdose protection?
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How does ENSC's PF614-MPAR differ from NaV1.8 inhibitors in pain treatment?
