FDA Study May Proceed Notice Received for Phase 2 Trial of TPST-1495 for the Treatment of Familial Adenomatous Polyposis (FAP)
Tempest Therapeutics (TPST) has received FDA clearance to proceed with a Phase 2 clinical trial for TPST-1495, their novel dual receptor inhibitor of prostaglandin signaling, to treat Familial Adenomatous Polyposis (FAP). This marks the company's second clinical program entering Phase 2, with data expected in 2026.
The study will be conducted by the Cancer Prevention Clinical Trials Network and funded by the National Cancer Institute's Division of Cancer Prevention. The trial aims to develop new treatment options for FAP, a high-risk condition that significantly increases the risk of multiple GI cancers. The Phase 2 study is scheduled to begin in 2025.
Tempest Therapeutics (TPST) ha ricevuto l'approvazione della FDA per procedere con un trial clinico di Fase 2 per TPST-1495, il loro nuovo inibitore duale dei recettori del segnale della prostaglandina, per trattare la Poliposi Adenomatosa Familiare (FAP). Questo segna il secondo programma clinico dell'azienda che entra in Fase 2, con dati attesi nel 2026.
Lo studio sarà condotto dal Cancer Prevention Clinical Trials Network e finanziato dalla Divisione di Prevenzione del Cancro del National Cancer Institute. Il trial mira a sviluppare nuove opzioni di trattamento per la FAP, una condizione ad alto rischio che aumenta significativamente il rischio di molteplici tumori gastrointestinali. Lo studio di Fase 2 è previsto per iniziare nel 2025.
Tempest Therapeutics (TPST) ha recibido la aprobación de la FDA para proceder con un ensayo clínico de Fase 2 para TPST-1495, su nuevo inhibidor dual de receptores de señalización de prostaglandinas, para tratar la Poliposis Adenomatosa Familiar (FAP). Esto marca el segundo programa clínico de la compañía que entra en Fase 2, con datos esperados para 2026.
El estudio será conducido por el Cancer Prevention Clinical Trials Network y financiado por la División de Prevención del Cáncer del Instituto Nacional del Cáncer. El ensayo tiene como objetivo desarrollar nuevas opciones de tratamiento para la FAP, una condición de alto riesgo que aumenta significativamente el riesgo de múltiples cánceres gastrointestinales. El estudio de Fase 2 está programado para comenzar en 2025.
Tempest Therapeutics (TPST)는 TPST-1495에 대한 2상 임상 시험을 진행할 수 있도록 FDA의 승인을 받았습니다. 이는 그들의 새로운 프로스타글란딘 신호 전달 이중 수용체 억제제로, 가족성 선종성 폴립증 (FAP) 치료를 위한 것입니다. 이는 회사의 두 번째 임상 프로그램이 2상에 진입하는 것으로, 데이터는 2026년에 예상됩니다.
이 연구는 Cancer Prevention Clinical Trials Network에 의해 수행되며, 국가암연구소의 암 예방 부서에서 자금을 지원받습니다. 이 시험은 FAP에 대한 새로운 치료 옵션을 개발하는 것을 목표로 하며, 이는 여러 위장관 암의 위험을 크게 증가시키는 고위험 상태입니다. 2상 연구는 2025년에 시작될 예정입니다.
Tempest Therapeutics (TPST) a reçu l'approbation de la FDA pour procéder à un essai clinique de Phase 2 pour TPST-1495, leur nouvel inhibiteur des récepteurs doubles de la signalisation des prostaglandines, afin de traiter la Polypose Adenomateuse Familiale (FAP). Cela marque le deuxième programme clinique de l'entreprise entrant en Phase 2, avec des données attendues en 2026.
L'étude sera menée par le Cancer Prevention Clinical Trials Network et financée par la Division de Prévention du Cancer de l'Institut National du Cancer. L'essai vise à développer de nouvelles options de traitement pour la FAP, une condition à haut risque qui augmente considérablement le risque de plusieurs cancers gastro-intestinaux. L'étude de Phase 2 devrait commencer en 2025.
Tempest Therapeutics (TPST) hat die Genehmigung der FDA erhalten, um mit einer Phase-2-Studie für TPST-1495 fortzufahren, ihrem neuartigen dualen Rezeptor-Inhibitor für die Prostaglandin-Signalgebung zur Behandlung von Familiärer Adenomatöser Polyposis (FAP). Dies markiert das zweite klinische Programm des Unternehmens, das in Phase 2 eintritt, mit Daten, die für 2026 erwartet werden.
Die Studie wird vom Cancer Prevention Clinical Trials Network durchgeführt und von der Abteilung für Krebsprävention des National Cancer Institute finanziert. Die Studie zielt darauf ab, neue Behandlungsoptionen für FAP zu entwickeln, eine Hochrisikobedingung, die das Risiko für multiple GI-Krebserkrankungen erheblich erhöht. Die Phase-2-Studie soll 2025 beginnen.
- FDA clearance received for Phase 2 trial
- NCI funding support secured for the trial
- Second clinical program reaching Phase 2 stage
- Data results not expected until 2026
Second clinical program entering Phase 2 with data expected 2026
BRISBANE, Calif., March 13, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-class1 targeted and immune-mediated therapeutics to fight cancer, today announced that the Cancer Prevention Clinical Trials Network received a “Study May Proceed” letter from the U.S. Food and Drug Administration (FDA) to evaluate TPST-1495, the company’s novel dual receptor inhibitor of prostaglandin (PGE2) signaling, in a Phase 2 clinical trial for the treatment of patients with Familial Adenomatous Polyposis (FAP).
“Receiving the FDA’s clearance to proceed with our Phase 2 clinical trial for TPST-1495, our second clinical program, in FAP marks an important step forward in developing new treatment options for patients suffering from this high-risk disease that significantly increases the risk of multiple GI cancers,” said Sam Whiting M.D., Ph.D., chief medical officer and head of R&D of Tempest. “This collaboration with the Cancer Prevention Clinical Trials Network, financially supported by the National Cancer Institute’s Division of Cancer Prevention, underscores the urgent need for innovative approaches in cancer prevention, and we look forward to advancing this potential promising therapy to help patients facing this difficult disease."
The Phase 2 study in patients with FAP will begin this year and will be run by the Cancer Prevention Clinical Trials Network and funded by the National Cancer Institute (“NCI”) Division of Cancer Prevention.
About the TPST-1495 FAP Study
The planned Phase 2 study will evaluate the efficacy and safety of TPST-1495 in patients with Familial Adenomatous Polyposis (FAP) who have previously undergone colectomy. The primary efficacy objective is to assess the activity of TPST-1495 in reducing duodenal polyp burden in patients with FAP comparing baseline endoscopy to endoscopy after 6 months of treatment with TPST-1495. Additional objectives include reduction of polyp burden in retained rectum or IPAA and to assess the safety of TPST-1495.
About Tempest Therapeutics
Tempest Therapeutics is a clinical-stage biotechnology company advancing a diverse portfolio of small molecule product candidates containing tumor-targeted and/or immune-mediated mechanisms with the potential to treat a wide range of tumors. The company’s novel programs range from early research to later-stage investigation in a randomized global study in first-line cancer patients. Tempest is headquartered in Brisbane, California. More information about Tempest can be found on the company’s website at www.tempesttx.com.
Forward-Looking Statements
This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended (the “Securities Act”)) concerning Tempest Therapeutics, Inc. These statements may discuss goals, intentions, and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Tempest Therapeutics, as well as assumptions made by, and information currently available to, management of Tempest Therapeutics. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “could”, “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” and other similar expressions. All statements that are not historical facts are forward-looking statements, including any statements regarding: the design, initiation, progress, timing, scope and results of clinical trials, including the anticipated Phase 3 study for amezalpat; anticipated therapeutic benefit and regulatory development of the Company’s product candidates the Company’s ability to advance into a late-stage clinical company; and the Company’s ability to achieve its operational plans. Forward-looking statements are based on information available to Tempest Therapeutics as of the date hereof and are not guarantees of future performance. Any factors may cause differences between current expectations and actual results, including: unexpected safety or efficacy data observed during preclinical or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied are discussed in greater detail in the “Risk Factors” section of the Company’s Quarterly Report on Form 10-Q filed for the quarter ended September 30, 2024 and other documents filed by the Company from time to time with the Securities and Exchange Commission. Except as required by applicable law, Tempest Therapeutics undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Tempest Therapeutics’ views as of any date subsequent to the date of this press release and should not be relied upon as prediction of future events. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Tempest Therapeutics.
Investor & Media Contacts:
Sylvia Wheeler
Wheelhouse Life Science Advisors
swheeler@wheelhouselsa.com
Aljanae Reynolds
Wheelhouse Life Science Advisors
areynolds@wheelhouselsa.com
1 If approved by the FDA
FAQ
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