PainReform Provides Further Update on Phase 3 Clinical Trial of PRF-110
PainReform (Nasdaq: PRFX) provided an update on its Phase 3 clinical trial of PRF-110 for post-surgical pain management in bunionectomy patients. While the trial showed statistically significant superiority over placebo in pain reduction during the first 48 hours post-surgery, the company revealed that data from the final 24-hour period could not be clarified to meet the study's primary endpoint 72-hour requirement. As a result, the trial did not achieve its primary endpoint.
The company has initiated R&D activities to better understand and refine PRF-110's pharmaco-kinetics and pharmaco-dynamics based on study data. Management plans to use high-level, in-vitro models to address the 72-hour requirement issue before conducting additional clinical work. The company is also reviewing strategic options.
PainReform (Nasdaq: PRFX) ha fornito un aggiornamento sul suo trial clinico di Fase 3 riguardante PRF-110 per la gestione del dolore post-operatorio nei pazienti sottoposti a bunionectomia. Sebbene il trial abbia mostrato una superiorità statisticamente significativa rispetto al placebo nella riduzione del dolore nelle prime 48 ore post-intervento, l'azienda ha rivelato che i dati dell'ultimo periodo di 24 ore non potevano essere chiariti per soddisfare il requisito primario dello studio di 72 ore. Di conseguenza, il trial non ha raggiunto il suo obiettivo primario.
L'azienda ha avviato attività di ricerca e sviluppo per comprendere meglio e perfezionare la farmacocinetica e la farmacodinamica di PRF-110 sulla base dei dati dello studio. La gestione prevede di utilizzare modelli in vitro di alto livello per affrontare la questione del requisito di 72 ore prima di condurre ulteriori lavori clinici. L'azienda sta anche esaminando opzioni strategiche.
PainReform (Nasdaq: PRFX) proporcionó una actualización sobre su ensayo clínico de Fase 3 de PRF-110 para el manejo del dolor postoperatorio en pacientes sometidos a una bunionectomía. Si bien el ensayo mostró una superioridad estadísticamente significativa sobre el placebo en la reducción del dolor durante las primeras 48 horas después de la cirugía, la compañía reveló que los datos del último período de 24 horas no pudieron ser aclarados para cumplir con el requisito de 72 horas del objetivo primario del estudio. Como resultado, el ensayo no alcanzó su objetivo primario.
La compañía ha iniciado actividades de I+D para comprender mejor y refinar la farmacocinética y la farmacodinamia de PRF-110 basándose en los datos del estudio. La dirección planea utilizar modelos in vitro de alto nivel para abordar el problema del requisito de 72 horas antes de realizar trabajos clínicos adicionales. La empresa también está revisando opciones estratégicas.
PainReform (Nasdaq: PRFX)는 PRF-110의 수술 후 통증 관리에 대한 3상 임상 시험에 대한 업데이트를 제공했습니다. 이 시험은 수술 후 첫 48시간 동안 통증 감소에서 위약에 비해 통계적으로 유의미한 우위를 나타냈으나, 회사는 최종 24시간 기간의 데이터가 72시간의 주요 목표 요건을 충족시키기 위한 명확한 수치를 제시할 수 없었다고 밝혔습니다. 따라서 이 시험은 주요 목표를 달성하지 못했습니다.
회사는 연구 데이터를 기반으로 PRF-110의 약동학 및 약력학을 더 잘 이해하고 다듬기 위한 연구개발 활동을 시작했습니다. 경영진은 추가 임상 작업을 수행하기 전에 72시간 요건 문제를 해결하기 위해 고수준의 시험관 모델을 사용할 계획입니다. 회사는 또한 전략적 옵션을 검토하고 있습니다.
PainReform (Nasdaq: PRFX) a fourni une mise à jour sur son essai clinique de phase 3 concernant PRF-110 pour la gestion de la douleur post-chirurgicale chez les patients ayant subi une opération de hallux valgus. Bien que l'essai ait montré une supériorité statistiquement significative par rapport au placebo dans la réduction de la douleur pendant les 48 premières heures suivant l'opération, la société a révélé que les données de la dernière période de 24 heures n'avaient pas pu être clarifiées pour répondre à l'exigence de 72 heures du critère principal de l'étude. Par conséquent, l'essai n'a pas atteint son critère principal.
La société a lancé des activités de recherche et développement pour mieux comprendre et affiner la pharmacocinétique et la pharmacodynamique de PRF-110 sur la base des données de l'étude. La direction prévoit d'utiliser des modèles in vitro de haut niveau pour traiter le problème de l'exigence de 72 heures avant de procéder à des travaux cliniques supplémentaires. L'entreprise examine également des options stratégiques.
PainReform (Nasdaq: PRFX) hat ein Update zu seiner Phase-3-Studie über PRF-110 zur Schmerzbehandlung nach Operationen bei Patienten, die sich einer Hallux-valgus-Operation unterzogen haben, bereitgestellt. Während die Studie eine statistisch signifikante Überlegenheit gegenüber dem Placebo bei der Schmerzlinderung in den ersten 48 Stunden nach der Operation zeigte, gab das Unternehmen bekannt, dass die Daten des letzten 24-Stunden-Zeitraums nicht klargestellt werden konnten, um die 72-Stunden-Anforderung des Hauptziels der Studie zu erfüllen. Infolgedessen erreichte die Studie ihr Hauptziel nicht.
Das Unternehmen hat Forschungs- und Entwicklungsaktivitäten initiiert, um die Pharmakokinetik und Pharmakodynamik von PRF-110 auf Basis der Studiendaten besser zu verstehen und zu verfeinern. Das Management plant, hochgradige In-vitro-Modelle zu verwenden, um das 72-Stunden-Anforderungsproblem zu adressieren, bevor zusätzliche klinische Arbeiten durchgeführt werden. Das Unternehmen prüft auch strategische Optionen.
- Demonstrated statistically significant pain reduction vs placebo in first 48 hours post-surgery
- Initiated R&D activities to refine product profile
- Failed to meet primary endpoint requirement for 72-hour pain reduction
- Unable to clarify data from final 24-hour period
- Additional clinical trials likely required
- Strategic review indicates potential uncertainty about project's future
Insights
The company's decision to return to R&D for pharmacokinetic and pharmacodynamic refinement indicates fundamental challenges with the drug's formulation that weren't apparent in earlier development stages. This outcome will likely necessitate additional pre-clinical work and potential reformulation before any new clinical trials can be initiated, significantly extending the development timeline and increasing costs.
From a development perspective, the fact that the drug showed efficacy for 48 hours but failed at 72 hours suggests a specific technical challenge related to the extended-release properties of the formulation, rather than a complete failure of the therapeutic concept. However, resolving these issues will require substantial additional investment and time, with no guarantee of success.
The announcement of a strategic review suggests potential corporate actions ranging from seeking partnerships to exploring sale options, indicating significant uncertainty about the company's independent path forward.
For investors, several critical factors warrant attention: 1) The additional R&D expenditure required to resolve the formulation issues will further strain the company's financial resources, 2) The timeline to potential commercialization has been substantially extended and 3) The company's bargaining position for any strategic alternatives has been weakened by this setback. Given PainReform's market cap of
TEL AVIV, Israel, Dec. 27, 2024 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today announced an update regarding its Phase 3 clinical trial evaluating PRF-110 in post-surgical pain management of patients undergoing bunionectomy.
PainReform previously disclosed initial topline data from its Phase 3 clinical trial in which it reported that it demonstrated statistically significant superiority over placebo in reducing pain during the first 48 hours following surgery. Yet, at that time, data pertaining to the last 24-hour period of the 72-hour study follow-up was unclear, and efforts were made to resolve the incoherence and complete the analysis.
Following further investigation, PainReform has determined that the data from the final 24-hour period could not be clarified to satisfy the study’s primary endpoint 72 hours requirement, and therefore, it did not meet the primary endpoint of the study. Despite this setback, the Company has initiated research and development (R&D) activities to better understand and refine the pharmaco-kinetics and pharmaco-dynamics of PRF-110 based on the data received from the study. These efforts are intended to potentially resolve this issue to support future clinical trials.
"We are focused on resolving the issue of the last 24 of the 72-hour requirement through the use of high-level, in-vitro models prior to any additional clinical work," said Dr. Ehud Geller, Chairman and interim CEO of PainReform. "This update reflects our determination to leverage these learnings and continue our mission to provide effective pain relief solutions for surgical patients. Our ongoing R&D efforts aim to deepen our understanding of PRF-110’s profile and enhance its potential in future evaluations. In parallel, we are reviewing our strategic options. There can be no assurance that our review will result in any transaction or that it will enhance shareholder value.”
About PainReform
PainReform is a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics. PRF-110, the Company's lead product is based on the local anesthetic ropivacaine, targeting the postoperative pain relief market. PRF-110 is an oil-based, viscous, clear solution that is deposited directly into the surgical wound bed prior to closure to provide localized and extended postoperative analgesia. The Company's proprietary extended- release drug-delivery system is designed to provide an extended period of post-surgical pain relief without the need for repeated dose administration while reducing the potential need for the use of opiates. For more information, please visit www.painreform.com.
Notice Regarding Forward-Looking Statements
This press release contains forward-looking statements about our expectations, beliefs and intentions including with respect to objectives, plans and strategies and expected timing of results. Forward-looking statements can be identified by the use of forward-looking words such
as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. These forward-looking statements are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of our control. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward- looking statements, including, but not limited to, the following: our ability to identify, evaluate and complete any strategic alternative that yields value for our shareholders, our ability to continue as a going concern, our history of significant losses, our need to raise additional capital and our ability to obtain additional capital on acceptable terms, or at all; our dependence on the success of our initial product candidate, PRF-110; the outcomes of preclinical studies, clinical trials and other research regarding PRF-110 and future product candidates; our limited experience managing clinical trials; our ability to retain key personnel and recruit additional employees; our reliance on third parties for the conduct of clinical trials, product manufacturing and development; the impact of competition and new technologies; our ability to comply with regulatory requirements relating to the development and marketing of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights and our ability to operate our business without infringing the intellectual property rights of others; the overall global economic environment; our ability to develop an active trading market for our ordinary shares and whether the market price of our ordinary shares is volatile; our ability to maintain our listing on the Nasdaq Capital Market; and statements as to the impact of the political and security situation in Israel on our business, including due to the current war in Israel. More detailed information about the risks and uncertainties affecting us is contained under the heading "Risk Factors" included in the Company's most recent Annual Report on Form 20-F and in other filings that we have made and may make with the Securities and Exchange Commission in the future.
Contact:
Crescendo Communications, LLC
Tel: 212-671-1021
Email: prfx@crescendo-ir.com
Dr. Ehud Geller
Chairman and interim Chief Executive Officer
PainReform Ltd.
Tel: +972-54-4236711
Email: egeller@medicavp.com
FAQ
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