Tharimmune Reports Pharmacokinetic Simulation Results for TH104 as Prophylaxis Against Respiratory Depression from Fentanyl and Ultrapotent Opioids, Highlighting Potential Superiority Over Existing Treatments
Tharimmune (Nasdaq:THAR) announced positive pharmacokinetic simulation results for TH104, its buccal film formulation of nalmefene, designed as a prophylactic treatment against respiratory depression from fentanyl and ultrapotent opioids.
The simulation analysis revealed that TH104 achieves protective effects within 30 minutes post-dose and maintains protection for approximately 24 hours, potentially offering superior duration compared to existing treatments like naloxone. The non-injectable buccal delivery system provides rapid absorption and convenient administration for first responders and military personnel.
Notably, the FDA previously indicated that no additional clinical trials appear necessary before a 505(b)(2) New Drug Application submission, streamlining the path to potential approval.
Tharimmune (Nasdaq:THAR) ha comunicato risultati favorevoli di simulazione farmacocinetica per TH104, la sua formulazione in film buccale di nalmefene, studiata come trattamento profilattico contro la depressione respiratoria indotta da fentanyl e oppioidi ultrapotenti.
L'analisi simulativa ha mostrato che TH104 raggiunge effetti protettivi entro 30 minuti dalla somministrazione e mantiene la protezione per circa 24 ore, offrendo potenzialmente una durata superiore rispetto a trattamenti esistenti come il naloxone. Il sistema di somministrazione buccale non iniettabile garantisce un assorbimento rapido e una somministrazione pratica per soccorritori e personale militare.
Da notare che la FDA ha indicato in precedenza che non sembrano necessarie ulteriori sperimentazioni cliniche prima della presentazione di una domanda di autorizzazione 505(b)(2), semplificando il percorso verso una possibile approvazione.
Tharimmune (Nasdaq:THAR) anunció resultados favorables de simulaciones farmacocinéticas para TH104, su formulación en película bucal de nalmefeno, diseñada como tratamiento profiláctico contra la depresión respiratoria causada por fentanilo y opioides ultrapotentes.
El análisis de simulación reveló que TH104 alcanza efectos protectores en 30 minutos tras la dosis y mantiene la protección durante aproximadamente 24 horas, ofreciendo potencialmente una duración superior frente a tratamientos existentes como la naloxona. El sistema de administración bucal no inyectable permite una absorción rápida y una aplicación cómoda para los primeros auxilios y personal militar.
Cabe destacar que la FDA indicó previamente que no parecen necesarias ensayos clínicos adicionales antes de presentar una solicitud de nuevo fármaco 505(b)(2), lo que agiliza el camino hacia una posible aprobación.
Tharimmune (Nasdaq:THAR)는 펜타닐 및 초강력 오피오이드로 인한 호흡억제를 예방하기 위해 설계된 날메펜의 구강점막 필름 제형인 TH104에 대한 유리한 약물동태 시뮬레이션 결과를 발표했습니다.
시뮬레이션 분석에 따르면 TH104는 투약 후 30분 이내에 보호 효과에 도달하며 약 24시간 동안 보호 효과를 유지해, 나록손과 같은 기존 치료제보다 더 긴 지속성을 제공할 가능성이 있습니다. 주사형이 아닌 구강 투여 방식은 빠른 흡수와 현장 응급요원 및 군인에게 적합한 편리한 투여를 제공합니다.
특히 FDA는 이전에 505(b)(2) 신약허가 신청 제출 전 추가 임상시험이 필요하지 않아 보인다고 밝혀, 승인 가능성으로 가는 절차가 간소화되었습니다.
Tharimmune (Nasdaq:THAR) a annoncé des résultats positifs de simulations pharmacocinétiques pour TH104, sa formulation en film buccal de nalmefène, conçue comme traitement prophylactique contre la dépression respiratoire due au fentanyl et aux opioïdes ultrapuissants.
L'analyse de simulation a montré que TH104 atteint un effet protecteur en 30 minutes après la prise et maintient la protection pendant environ 24 heures, offrant potentiellement une durée supérieure aux traitements existants tels que la naloxone. Le système d'administration buccal non injectable assure une absorption rapide et une administration pratique pour les premiers intervenants et le personnel militaire.
Il est à noter que la FDA a indiqué précédemment qu'aucun essai clinique supplémentaire ne semblait nécessaire avant le dépôt d'une demande de nouveau médicament 505(b)(2), simplifiant ainsi la voie vers une éventuelle approbation.
Tharimmune (Nasdaq:THAR) gab positive pharmakokinetische Simulationsergebnisse für TH104 bekannt, seine buccale Filmmatrix‑Formulierung von Nalmefen, die als prophylaktische Behandlung gegen Atemdepression durch Fentanyl und ultrapotente Opioide entwickelt wurde.
Die Simulationsanalyse zeigte, dass TH104 binnen 30 Minuten nach Gabe Schutzwirkung erreicht und diese für etwa 24 Stunden aufrechterhält, womit es möglicherweise eine längere Wirkdauer als bestehende Behandlungen wie Naloxon bietet. Das nichtinvasive bukkale Applikationssystem ermöglicht eine rasche Resorption und eine unkomplizierte Verabreichung für Rettungskräfte und Militärpersonal.
Bemerkenswert ist, dass die FDA zuvor angab, dass vor Einreichung eines 505(b)(2)-New‑Drug‑Applications offenbar keine zusätzlichen klinischen Studien erforderlich seien, was den Weg zu einer möglichen Zulassung vereinfacht.
- TH104 shows 24-hour protection window, significantly longer than naloxone's 30-90 minute duration
- FDA confirmed no additional clinical trials needed before NDA submission
- Non-injectable buccal film delivery offers practical advantages for first responders
- Protective effects achieved within 30 minutes of administration
- Results based on simulations rather than real-world clinical data
- Product still requires FDA approval before commercialization
Insights
Tharimmune's TH104 shows promising 24-hour protection against fentanyl-induced respiratory depression, potentially outperforming short-acting naloxone.
Tharimmune has released pharmacokinetic simulation results for TH104, their buccal film formulation of nalmefene, showing considerable promise as a prophylactic treatment against fentanyl and ultrapotent opioid exposure. The data reveals two critical advantages over existing treatments like naloxone: significantly longer duration of protection and non-injectable administration.
The pharmacokinetic simulations indicate TH104 reaches protective concentrations within 30 minutes post-administration and maintains this protection for approximately 24 hours. This represents a dramatic improvement over naloxone injections, which typically provide protection for only 30-90 minutes. For military personnel or first responders potentially facing weaponized opioid exposure, this extended protection window addresses a critical vulnerability in current countermeasures.
The buccal film delivery system offers substantial practical advantages for field use, particularly for personnel wearing protective equipment where administering injections would be challenging. This user-friendly approach could significantly improve deployment in high-risk scenarios.
Perhaps most significant from a regulatory and commercial perspective is the FDA's feedback that no additional clinical trials appear necessary before submitting a 505(b)(2) New Drug Application. This accelerated pathway could substantially reduce time-to-market and development costs.
While these results come from simulations rather than human challenge studies (which would be ethically problematic given the risks), the data leverages established pharmacokinetic principles combined with their Phase 1 study results to model efficacy, providing a reasonable scientific basis for these conclusions.
RED BANK, NJ / ACCESS Newswire / August 20, 2025 / Tharimmune, Inc. (Nasdaq:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company dedicated to developing innovative therapeutic candidates for inflammation, immunology, and unmet medical needs announced positive results from a recent pharmacokinetic (PK) simulation analysis of its lead clinical asset, TH104, a buccal film formulation of nalmefene. The results reinforce the potential of TH104 as a prophylactic countermeasure for military personnel and chemical incident responders who may be exposed to high-potency opioids, including weaponized fentanyl and its analogues.
Fentanyl and related compounds pose national security threats due to their high potency and the potential for a devastating mass casualty incident if weaponized. There is a critical need for countermeasures that can be administered proactively, prior to potential exposure, to prevent or mitigate the rapid onset of respiratory and nervous system depression from these potent agents.
The analysis used pharmacokinetic simulations of TH104 as prophylaxis for respiratory depression in exposure to synthetic opioids based on data from the literature. The concentrations of TH104 necessary to block fentanyl respiratory depression were derived and simulations involved data from our Phase 1 study to generate concentration time curves above these concentrations. Using a conservative nalmefene concentration target - a threshold effect, (i.e. the protection from respiratory depression) was found to be achieved in approximately 30 minutes post dose and shown to maintain above this protection for about 24 hours. This is a potential key superiority of TH104 compared to currently available options (e.g. naloxone injection products). While naloxone injection can be used as a life-saving rescue medication, its effect is relatively short-lived, often lasting approximately 30-90 minutes. The prolonged prophylactic window of TH104 could be crucial in high-risk environments where exposure is a constant threat and immediate access to medical personnel may be limited. The ability of TH104 to potentially provide sustained protection is a significant advancement in prophylactic care against these potent agents.
The buccal film delivery of TH104 is designed as a non-injectable, rapid absorption and convenient-to-use administration, which may be advantageous for first responders who may be wearing full protective gear. The recent positive feedback earlier this year from the U.S. Food and Drug Administration (FDA) confirming that no additional clinical trials appear necessary prior to a 505(b)(2) New Drug Application (NDA) submission provides a path forward. Tharimmune is dedicated to advancing TH-104 to provide a potentially effective and patient-friendly treatment as an option for those in need, beginning with its critical role in national security.
About Tharimmune, Inc.
Tharimmune is a clinical-stage biotechnology company developing a diverse portfolio of therapeutic candidates in immunology, inflammation and oncology. Its lead clinical asset, TH104, is being developed for a specific indication via a 505(b)2 pathway for respiratory and/or nervous system depression in military personnel and chemical incident responders who may encounter environments contaminated with high-potency opioids. The expanded pipeline includes other indications for TH104, such as chronic pruritus in primary biliary cholangitis and TH023, a new approach to treating autoimmune diseases along with an early-stage multispecific biologic platform targeting unique epitopes against multiple solid tumors through its proprietary EpiClick™ Technology. The Company has a license agreement with OmniAb, Inc. to access their antibody discovery technology for targeting specified disease markers. Tharimmune continues to position itself as a leader in patient-centered innovation while working to deliver long-term value for shareholders. For more information, visit: www.tharimmune.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, contained in this press release, including statements regarding the timing and design of Tharimmune's future Phase 2 trial, Tharimmune's strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "continue," "could," "depends," "estimate," "expect," "intend," "may," "ongoing," "plan," "potential," "predict," "project," "target," "should," "will," "would," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Factors that may cause such differences, include, but are not limited to, those discussed under Risk Factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2024 and other periodic reports filed by the Company from time to time with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. Subsequent events and developments may cause the Company's views to change; however, the Company does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release.
Contacts:
Tharimmune, Inc.
ir@tharimmune.com
SOURCE: Tharimmune Inc.
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