Ensysce Biosciences Provides Mid-Year 2024 Update
Ensysce Biosciences (NASDAQ:ENSC) provides a mid-year 2024 update on its clinical-stage pharmaceutical developments for severe pain relief with reduced opioid abuse and overdose potential. Key highlights include:
1. PF614: Completed End of Phase 2 FDA meeting, published bioequivalence study results, and established manufacturing partnerships.
2. PF614-MPAR: Received FDA Breakthrough Therapy designation, applied for $15 million NIH/NIDA grant, and advanced to second clinical trial.
3. Opioid Use Disorder (OUD) program: Selected lead drug candidate PF9001, a TAAP methadone analogue with potentially lower cardiovascular side effects.
The company is finalizing the PF614 Phase 3 protocol and anticipates initiating enrollment later in 2024. Ensysce continues to seek non-dilutive federal funding to support its innovative pain relief solutions.
Ensysce Biosciences (NASDAQ:ENSC) fornisce un aggiornamento a metà anno 2024 sui suoi sviluppi farmaceutici in fase clinica per il sollievo dal dolore severo, riducendo l'abuso di oppioidi e il potenziale di overdose. Tra i punti salienti ci sono:
1. PF614: Completato l'incontro di fine fase 2 con la FDA, pubblicati i risultati dello studio di bioequivalenza e stabilite partnership di produzione.
2. PF614-MPAR: Ricevuta la designazione di Terapia Innovativa dalla FDA, richiesta di un finanziamento NIH/NIDA di 15 milioni di dollari e avanzamento al secondo trial clinico.
3. Programma per il Disturbo da Uso di Oppioidi (OUD): Selezionato il candidato farmaco principale PF9001, un analogo della metadone TAAP con potenziali effetti collaterali cardiovascolari ridotti.
La società sta finalizzando il protocollo della fase 3 per PF614 e prevede di avviare l'arruolamento entro la fine del 2024. Ensysce continua a cercare finanziamenti federali non diluitivi per supportare le sue soluzioni innovative nel sollievo dal dolore.
Ensysce Biosciences (NASDAQ:ENSC) proporciona una actualización a mitad de año de 2024 sobre sus desarrollos farmacéuticos en etapa clínica para el alivio del dolor severo con un menor abuso de opioides y potencial de sobredosis. Los aspectos destacados incluyen:
1. PF614: Se completó la reunión de fin de fase 2 con la FDA, se publicaron los resultados del estudio de bioequivalencia y se establecieron asociaciones de fabricación.
2. PF614-MPAR: Recepcionó la designación de Terapia Innovadora por parte de la FDA, solicitó una subvención de 15 millones de dólares del NIH/NIDA y avanzó al segundo ensayo clínico.
3. Programa de Trastorno por Uso de Opioides (OUD): Seleccionado el candidato a fármaco principal PF9001, un análogo de metadona TAAP con efectos secundarios cardiovasculares potencialmente menores.
La empresa está finalizando el protocolo de fase 3 para PF614 y anticipa iniciar la inscripción más tarde en 2024. Ensysce continúa buscando financiamiento federal no dilutivo para apoyar sus soluciones innovadoras de alivio del dolor.
Ensysce Biosciences (NASDAQ:ENSC)는 심각한 통증 완화를 위한 임상 단계의 제약 개발에 대한 2024년 중간 업데이트를 제공하며, 오피오이드 남용 및 과다복용의 가능성을 줄이고 있습니다. 주요 하이라이트는 다음과 같습니다:
1. PF614: FDA의 2상 종료 회의를 완료하고, 생물학적 동등성 연구 결과를 발표했으며, 제조 파트너십을 확립했습니다.
2. PF614-MPAR: FDA로부터 혁신 치료 지정 승인을 받았으며, 1500만 달러의 NIH/NIDA 보조금을 신청하고 두 번째 임상 시험으로 진입했습니다.
3. 오피오이드 사용 장애(OUD) 프로그램: 심혈관 부작용이 낮을 것으로 예상되는 TAAP 메타돈 유사체 PF9001을 주요 약물 후보로 선정했습니다.
회사는 PF614의 3상 프로토콜을 마무리 중이며, 2024년 후반에 등록을 시작할 것으로 예상하고 있습니다. Ensysce는 혁신적인 통증 완화 솔루션을 지원하기 위해 비희석 연방 자금을 계속해서 찾고 있습니다.
Ensysce Biosciences (NASDAQ:ENSC) fournit une mise à jour à mi-année 2024 concernant ses développements pharmaceutiques en phase clinique pour le soulagement de la douleur sévère, tout en réduisant l'abus d'opioïdes et le risque de surdose. Les points clés incluent :
1. PF614 : Réunion de fin de phase 2 avec la FDA terminée, résultats d'études de bioéquivalence publiés et partenariats de fabrication établis.
2. PF614-MPAR : Obtention de la désignation de Thérapie Innovante par la FDA, demande de subvention NIH/NIDA de 15 millions de dollars et progression vers le deuxième essai clinique.
3. Programme de trouble lié à l'utilisation d'opioïdes (OUD) : Sélectionné le candidat médicament principal PF9001, un analogue de méthadone TAAP avec des effets secondaires cardiovasculaires potentiellement réduits.
L'entreprise finalise le protocole de phase 3 pour PF614 et prévoit de commencer l'inscription plus tard en 2024. Ensysce continue de rechercher des financements fédéraux non dilutifs pour soutenir ses solutions innovantes de soulagement de la douleur.
Ensysce Biosciences (NASDAQ:ENSC) gibt ein Update zur klinischen Entwicklung von Arzneimitteln zur Linderung starker Schmerzen mit reduziertem Risiko für Opioidmissbrauch und Überdosierungen für das Jahr 2024 bekannt. Zu den wichtigsten Punkten gehören:
1. PF614: Abschluss des Meetings zur Beendigung der Phase 2 mit der FDA, Veröffentlichung der Ergebnisse der Bioäquivalenzstudie und Etablierung von Produktionspartnerschaften.
2. PF614-MPAR: Erhalt der Breakthrough-Therapie-Bezeichnung von der FDA, Antrag auf einen Zuschuss in Höhe von 15 Millionen US-Dollar beim NIH/NIDA und Fortschritt zur zweiten klinischen Studie.
3. Programm zur Behandlung von Opioidabhängigkeit (OUD): Auswahl des führenden Arzneimittelkandidaten PF9001, einem TAAP-Methadonanalog mit potenziell geringeren kardiovaskulären Nebenwirkungen.
Das Unternehmen finalisiert derzeit das Phase-3-Protokoll für PF614 und plant, die Einschreibung Ende 2024 zu beginnen. Ensysce sucht weiterhin nach nicht verwässerndem, bundesstaatlichem Finanzierungsquellen zur Unterstützung seiner innovativen Schmerzlösung.
- Received FDA Breakthrough Therapy designation for PF614-MPAR
- Completed End of Phase 2 FDA meeting for PF614
- Published bioequivalence study results for PF614 compared to OxyContin
- Established manufacturing partnerships for commercial scale production of PF614
- Applied for $15 million non-dilutive grant funding from NIH and NIDA
- Selected lead drug candidate PF9001 for Opioid Use Disorder program
- Advancing to second clinical trial for PF614-MPAR
- None.
~ Ready to Commence PF614 Phase 3 Clinical Trial in 2024 ~
~ Continued Clinical Development of Overdose Protection Breakthrough Therapy ~
~ Identified Lead Clinical Candidate for Opioid Use Disorder Program ~
SAN DIEGO, CA / ACCESSWIRE / July 23, 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 provides a Company review and update on a successful first half of 2024, including achievement of Breakthrough Therapy designation from the U.S. Food & Drug Administration (FDA).
Recent clinical and development highlights:
PF614:
Successfully completed a PF614 End of Phase 2 meeting with the FDA, which provided guidance on strategy and design of the Phase 3 clinical program.
Published the results of clinical study P614-102, which determined that PF614 was bioequivalent to OxyContin, potentially allowing it to be developed through the shortened FDA 505(b)(2) regulatory pathway. The results were published in an article entitled ‘Clinical evaluation of PF614, a novel TAAPä prodrug of oxycodone, versus OxyContin® in a multi-ascending dose study with a bioequivalence arm in healthy volunteers'.
Established manufacturing partnerships with Societal CDMO, Porton Pharma Solutions, and Purisys LLC to position Ensysce for commercial scale production of PF614.
PF614-MPAR:
The FDA granted Breakthrough Therapy designation to PF614-MPAR, specifically acknowledging the potential impact of the innovative MPAR® overdose protection technology. Breakthrough Therapy is an elite designation that expedites the development and review of drugs that are intended to treat a serious condition where the drug may demonstrate substantial improvement over available therapies.
Applied for an additional
$15 million non-dilutive grant funding from National Institutes of Health (NIH) and National Institute on Drug Abuse (NIDA) to support three years of continued development for PF614-MPAR with a potential start date in the third quarter of 2024.Presented the clinical data for PF614-MPAR that resulted in the granting of Breakthrough Therapy designation at the NIH annual HEAL (Helping End Addiction Long term) meeting, and the PF614-MPAR platform was recognized in the Trailblazer Session presented at the 2024 American Association of Pain Medicine (AAPM) annual meeting.
Received guidance from the FDA for the efficient execution of the non-clinical program, potentially reducing required costs.
Advanced the PF614-MPAR program in a continued collaboration with Quotient Sciences to undertake a second clinical trial, PF614-MPAR-102, anticipated to start in the fourth quarter of 2024.
Opioid Use Disorder (OUD) program:
Achieved a major milestone in the Company's opioid use disorder (OUD) program with selection of a lead drug candidate. The lead candidate PF9001, a TAAP methadone analogue, has shown lower potential of cardiovascular side effects associated with traditional methadone treatment.
The OUD program is supported by non-dilutive grant funding through the Company's ongoing
$15 million multi-year NIDA HEAL award.
Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "Our team has made exceptional progress on all three of the company's discovery and development programs during the first half of 2024. We continued to make positive traction in successful meetings with the FDA relative to both the PF614 and PF614-MPAR programs. The PF614 Phase 3 protocol is currently being finalized and we look forward to initiating enrollment in the study later this year. We also are pleased to be working with Quotient Sciences to develop our second clinical protocol for PF614-MPAR. Following completion of the PF614-MPAR-102 trial, we anticipate another meeting with the FDA to discuss the clinical path of PF614-MPAR. Finally, we are continuing the non-clinical development of our OUD program and are exploring other opportunities for our TAAP/MPAR analogues for ADHD."
"Safety of opioids and access to pain care remain huge issues in the US. We remain optimistic on our path to commercialization of our drugs to help solve these two problems. Our TAAP platform is designed to reduce abuse and the inclusion of MPAR will create far safer therapeutic products to protect from oral overdose. In addition to our traditional means of financing, Ensysce consistently applies for non-dilutive federal government funding to support our groundbreaking work, with the goal of providing effective pain relief for those suffering with severe pain. We look forward to providing additional updates in the months ahead and appreciate the support of our industry partners to achieve our goals and the continued support of our dedicated shareholders," concluded Dr. Kirkpatrick.
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 (TAAP™) 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.
Definitions
TAAP: trypsin activated abuse protection - designed to protect against prescription drug abuse.
MPAR: multi-pill abuse resistance - designed to protect against abuse and accidental overdose.
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
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