Talphera Announces First Patient Enrolled in the Registrational Trial Evaluating Nafamostat for Anticoagulation of the Extracorporeal Circuit
Talphera (Nasdaq: TLPH) has announced the enrollment of the first patient in its NEPHRO CRRT registrational trial, evaluating nafamostat for anticoagulation in extracorporeal circuits. The study will involve 166 patients across 14 clinical sites in the United States. The primary endpoint is the mean post-filter activated clotting time over the first 24 hours, comparing nafamostat to placebo.
Dr. Stuart Goldstein, a renowned nephrologist, enrolled the first patient. Nafamostat has been a standard of care in Japan and South Korea for over 30 years, and Talphera aims to make it available in the U.S. market if approved. The company views this as a significant milestone in addressing the limitations of current anticoagulation options for continuous renal replacement therapy (CRRT).
Talphera (Nasdaq: TLPH) ha annunciato l'arruolamento del primo paziente nel suo trial registrativo NEPHRO CRRT, che valuta l'uso del nafamostat per l'anticoagulazione in circuiti extracorporei. Lo studio coinvolgerà 166 pazienti in 14 siti clinici negli Stati Uniti. L'obiettivo primario è il tempo di coagulazione attivato post-filtraggio medio nelle prime 24 ore, confrontando il nafamostat con il placebo.
Il Dr. Stuart Goldstein, un rinomato nefrologo, ha arruolato il primo paziente. Il nafamostat è stato uno standard di cura in Giappone e Corea del Sud per oltre 30 anni, e Talphera punta a renderlo disponibile nel mercato statunitense se approvato. L'azienda considera questo un traguardo significativo per affrontare le limitazioni delle attuali opzioni di anticoagulazione per la terapia di sostituzione renale continua (CRRT).
Talphera (Nasdaq: TLPH) ha anunciado la inscripción del primer paciente en su ensayo registracional NEPHRO CRRT, que evalúa el nafamostat para anticoagulación en circuitos extracorpóreos. El estudio involucrará a 166 pacientes en 14 sitios clínicos en Estados Unidos. El objetivo principal es el tiempo medio de coagulación activada post-filtro durante las primeras 24 horas, comparando nafamostat con un placebo.
El Dr. Stuart Goldstein, un renombrado nefrólogo, inscribió al primer paciente. El nafamostat ha sido un estándar de atención en Japón y Corea del Sur durante más de 30 años, y Talphera tiene como objetivo hacerlo disponible en el mercado estadounidense si obtiene la aprobación. La compañía considera esto un hito significativo para abordar las limitaciones de las opciones actuales de anticoagulación para la terapia de reemplazo renal continuo (CRRT).
탈페라(Nasdaq: TLPH)는 NEPHRO CRRT 등록 임상 시험에 첫 환자가 등록되었음을 발표했습니다. 이 시험은 혈액투석 회로에서 항응고제로 nafamostat를 평가합니다. 이 연구는 미국의 14개 임상 사이트에서 166명의 환자를 포함할 예정입니다. 주요 목표는 첫 24시간 동안 필터 후 평균 활성 응고 시간을 측정하여 nafamostat와 위약을 비교하는 것입니다.
저명한 신장 전문의인 Stuart Goldstein 박사가 첫 환자를 등록했습니다. Nafamostat는 일본과 한국에서 30년 이상 표준 치료법으로 사용되어 왔으며, 탈페라는 승인이 될 경우 미국 시장에서 이를 이용할 수 있도록 할 계획입니다. 이 회사는 현재의 지속적인 신장 대체 요법(CRRT)에 대한 항응고 옵션의 한계를 해결하는 데 있어 중요한 이정표라고 보고 있습니다.
Talphera (Nasdaq: TLPH) a annoncé l'inscription du premier patient dans son essai enregistré NEPHRO CRRT, qui évalue l'utilisation du nafamostat pour l'anticoagulation dans les circuits extracorporels. L'étude impliquera 166 patients dans 14 sites cliniques aux États-Unis. L'objectif principal est le temps moyen de coagulation activée post-filtre sur les premières 24 heures, comparant le nafamostat au placebo.
Le Dr Stuart Goldstein, un néphrologue de renom, a inscrit le premier patient. Le nafamostat est un standard de soins au Japon et en Corée du Sud depuis plus de 30 ans, et Talphera vise à le rendre disponible sur le marché américain si cela est approuvé. La société considère cela comme une étape significative pour répondre aux limitations des options d'anticoagulation actuelles pour la thérapie de remplacement rénal continue (CRRT).
Talphera (Nasdaq: TLPH) hat die Einschreibung des ersten Patienten in seine registrierte NEPHRO CRRT-Studie bekannt gegeben, in der Nafamostat zur Antikoagulation in extrakorporalen Kreisläufen evaluiert wird. Die Studie wird 166 Patienten an 14 klinischen Standorten in den Vereinigten Staaten einbeziehen. Das primäre Ziel ist die mittlere aktivierte Gerinnungszeit nach dem Filter über die ersten 24 Stunden, wobei Nafamostat mit einem Placebo verglichen wird.
Dr. Stuart Goldstein, ein angesehener Nephrologe, hat den ersten Patienten eingeschrieben. Nafamostat ist seit über 30 Jahren ein Standardbehandlungsansatz in Japan und Südkorea, und Talphera strebt an, es auf dem US-Markt verfügbar zu machen, sofern es genehmigt wird. Das Unternehmen betrachtet dies als einen bedeutenden Meilenstein, um die Einschränkungen der aktuellen Antikoagulationsoptionen für die kontinuierliche Nierenersatztherapie (CRRT) anzugehen.
- Enrollment of first patient in NEPHRO CRRT registrational trial
- Potential to address disadvantages of current U.S. anticoagulation products for extracorporeal circuits
- Nafamostat has been standard of care in Japan and South Korea for over 30 years
- None.
The initiation of the NEPHRO CRRT registrational trial for nafamostat marks a significant milestone in Talphera's clinical development program. This 166-patient study aims to evaluate nafamostat's efficacy in anticoagulation for continuous renal replacement therapy (CRRT), a critical procedure for patients with acute kidney injury.
The trial's design, focusing on the mean post-filter activated clotting time over the first 24 hours, is a robust primary endpoint that directly addresses the key performance metric for anticoagulants in CRRT. The involvement of Dr. Stuart Goldstein, a renowned nephrologist, adds credibility to the study and may facilitate faster patient recruitment.
If successful, nafamostat could provide a new anticoagulation option for CRRT in the U.S., potentially improving patient outcomes and reducing complications associated with current anticoagulants. However, investors should note that the road to FDA approval is still long and success is not guaranteed despite nafamostat's established use in Japan and South Korea.
The commencement of the NEPHRO CRRT trial is a positive development for Talphera (NASDAQ: TLPH), potentially expanding its product pipeline. While the financial impact is not immediate, successful trial results could lead to a new revenue stream in the future.
Investors should consider the market potential for nafamostat in the U.S. CRRT market, which could be substantial given the high incidence of acute kidney injury in intensive care units. However, it's important to factor in the costs associated with conducting the trial across 14 clinical sites and the time required for potential FDA approval.
Talphera's focus on therapies for medically supervised settings positions it in a niche market with potentially less competition. The company's ability to bring nafamostat, an established product in Asian markets, to the U.S. could be viewed favorably by investors as a lower-risk development strategy. Keep an eye on future trial updates and potential partnerships that could accelerate the path to commercialization.
The safety and effectiveness of nafamostat is being assessed in the NEPHRO CRRT registrational trial in 166 patients at up to 14 clinical sites
Primary endpoint in the NEPHRO CRRT study is measured over the first 24 hours, with patients completing the study after 72 hours
Dr. Stuart Goldstein, a world-renowned nephrologist, is the first physician to enroll a patient in the NEPHRO CRRT study
The NEPHRO CRRT registrational study will enroll 166 patients undergoing continuous renal replacement therapy (CRRT) at up to 14 clinical sites across
"We are excited to be able to offer participation in this nafamostat study to our patients requiring CRRT," stated Stuart Goldstein, M.D., Professor of Pediatrics and Director of the Center for Acute Care Nephrology at Cincinnati Children's Hospital Medical Center. "Nafamostat, if approved following this trial, will be a valuable addition to our anticoagulant options for many patients."
"We are pleased the first patient was enrolled in the study last week. Nafamostat has the potential to address disadvantages of the currently available
About Niyad and nafamostat
Nafamostat is a broad spectrum, synthetic serine protease inhibitor with anticoagulant, anti-inflammatory and potential anti-viral activities. Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an IDE, as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation Status from the FDA. Talphera's registrational study of Niyad™ is named the NEPHRO CRRT (Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) study. An ICD-10 procedural code, XY0YX37, has been issued for the extracorporeal introduction of nafamostat. The ICD-10 code is a specific/billable code that can be used to indicate a procedure. LTX-608 is a proprietary nafamostat formulation for direct IV infusion that may be investigated and developed for the treatment of acute respiratory distress syndrome (ARDS), disseminated intravascular coagulation (DIC), acute pancreatitis or as an anti-viral treatment, amongst other potential targets.
About Talphera, Inc.
Talphera, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. Talphera's lead product candidate, Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption (IDE) as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation status from the
This release is intended for investors only. For additional information about Talphera, please visit www.talphera.com.
About the NEPHRO CRRT Study
The NEPHRO Study, which has received central IRB approval, is designed as a prospective, double-blinded trial to be conducted at up to 14 U.S. hospital intensive care units. The study will enroll and evaluate 166 adult patients undergoing renal replacement therapy, who cannot tolerate heparin or are at risk for bleeding. The primary endpoint of the study is mean post-filter activated clotting time using Niyad versus placebo over the first 24 hours. Key secondary endpoints include filter lifespan, number of filter changes over 72 hours, number of transfusions over 72 hours and dialysis efficacy (based on urea concentration) over the first 24 hours.
Forward-looking statements
This press release contains forward-looking statements based upon Talphera's current expectations and assumptions. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believe," "expect," "finalize," "may," "if," "intends," "plans," "potential," "projected," "will," or the negative of these words or other comparable terminology, and include: Talphera's expectation that the NEPHRO study will enroll and complete efficiently, the potential of nafamostat to address unmet needs in anticoagulation of the extracorporeal circuit, and the potential advantage of having Breakthrough Device Designation and potential FDA approval of the nafamostat product candidate. Talphera's discussion of its strategy, plans and intentions also include forward-looking statements, which are predictions, projections and other statements about future events that are based on current expectations and assumptions. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including: (i) risks relating to Talphera's product development activities, including that clinical studies may not confirm any safety, efficacy or other product characteristics described or assumed in this press release; (ii) Talphera's developmental product candidates may not be beneficial to patients or healthcare providers or be successfully commercialized; (iii) risks relating to Talphera's ability to obtain regulatory approvals for its developmental product candidates; (iv) risks related to the ability of Talphera and its business partners to implement development plans, commercial launch plans, forecasts and other business expectations; and (v) risks related to Talphera's liquidity and its ability to maintain capital resources sufficient to conduct its clinical studies. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described under the caption "Risk Factors" and elsewhere in Talphera's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in Talphera's most recent annual, quarterly or current report as filed or furnished with the SEC. Talphera's SEC reports are available at www.talphera.com under the "Investors" tab. Except to the extent required by law, Talphera undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect new information, events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.
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SOURCE Talphera, Inc.
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