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Kezar Life Sciences to Present Topline Results from the PORTOLA Phase 2a Trial Evaluating Zetomipzomib for the Treatment of Patients with Autoimmune Hepatitis on March 25, 2025

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Kezar Life Sciences (Nasdaq: KZR) has announced an upcoming presentation of topline results from their PORTOLA Phase 2a trial evaluating zetomipzomib for treating autoimmune hepatitis (AIH). The presentation is scheduled for March 25, 2025, at 8:00 a.m. ET.

The PORTOLA trial is a placebo-controlled, randomized, double-blind Phase 2a clinical trial assessing the efficacy and safety of zetomipzomib in AIH patients. The event will feature presentations from key investigators including Dr. Craig Lammert from Indiana University School of Medicine and Dr. Gideon Hirschfield from Toronto General Hospital, followed by a Q&A session.

The presentation will be accessible via live audio webcast with slides, and a replay will be available for 90 days afterward on the company's website.

Kezar Life Sciences (Nasdaq: KZR) ha annunciato una prossima presentazione dei risultati preliminari del loro trial PORTOLA di fase 2a che valuta il zetomipzomib per il trattamento dell'epatite autoimmune (AIH). La presentazione è programmata per 25 marzo 2025, alle 8:00 ET.

Il trial PORTOLA è uno studio clinico di fase 2a, controllato con placebo, randomizzato e in doppio cieco, che valuta l'efficacia e la sicurezza del zetomipzomib nei pazienti con AIH. L'evento presenterà relazioni di importanti ricercatori, tra cui Dr. Craig Lammert della Indiana University School of Medicine e Dr. Gideon Hirschfield del Toronto General Hospital, seguite da una sessione di domande e risposte.

La presentazione sarà accessibile tramite webcast audio dal vivo con diapositive, e una registrazione sarà disponibile per 90 giorni successivi sul sito web dell'azienda.

Kezar Life Sciences (Nasdaq: KZR) ha anunciado una próxima presentación de los resultados preliminares de su ensayo PORTOLA de fase 2a que evalúa el zetomipzomib para el tratamiento de la hepatitis autoinmune (AIH). La presentación está programada para 25 de marzo de 2025, a las 8:00 a.m. ET.

El ensayo PORTOLA es un estudio clínico de fase 2a, controlado con placebo, aleatorizado y doble ciego, que evalúa la eficacia y seguridad del zetomipzomib en pacientes con AIH. El evento contará con presentaciones de investigadores clave, incluidos Dr. Craig Lammert de la Indiana University School of Medicine y Dr. Gideon Hirschfield del Toronto General Hospital, seguido de una sesión de preguntas y respuestas.

La presentación será accesible a través de una transmisión en vivo de audio con diapositivas, y una repetición estará disponible durante 90 días después en el sitio web de la empresa.

케자르 라이프 사이언스 (Nasdaq: KZR)는 자가면역 간염(AIH) 치료를 위한 제트모피조밉의 평가를 포함한 PORTOLA 2a 임상 시험의 주요 결과 발표를 예정하고 있다고 발표했습니다. 발표는 2025년 3월 25일 오전 8시 ET에 예정되어 있습니다.

PORTOLA 시험은 AIH 환자에서 제트모피조밉의 효능과 안전성을 평가하는 이중 맹검, 무작위, 위약 대조 Phase 2a 임상 시험입니다. 이 행사에서는 인디애나 대학교 의과대학의 Dr. Craig Lammert와 토론토 일반 병원의 Dr. Gideon Hirschfield를 포함한 주요 연구자들의 발표가 있을 예정이며, 이후에는 질의응답 시간이 있습니다.

발표는 슬라이드와 함께 실시간 오디오 웹캐스트를 통해 접근 가능하며, 이후 회사 웹사이트에서 90일 동안 재생할 수 있습니다.

Kezar Life Sciences (Nasdaq: KZR) a annoncé une prochaine présentation des résultats préliminaires de leur essai PORTOLA de phase 2a évaluant le zetomipzomib pour le traitement de l'hépatite auto-immune (AIH). La présentation est prévue pour le 25 mars 2025, à 8h00 ET.

L'essai PORTOLA est un essai clinique de phase 2a, contrôlé par placebo, randomisé et en double aveugle, évaluant l'efficacité et la sécurité du zetomipzomib chez les patients atteints d'AIH. L'événement comprendra des présentations de chercheurs clés, notamment Dr. Craig Lammert de l'Indiana University School of Medicine et Dr. Gideon Hirschfield de l'hôpital général de Toronto, suivies d'une séance de questions-réponses.

La présentation sera accessible via un webinaire audio en direct avec des diapositives, et une rediffusion sera disponible pendant 90 jours par la suite sur le site web de l'entreprise.

Kezar Life Sciences (Nasdaq: KZR) hat eine bevorstehende Präsentation der vorläufigen Ergebnisse ihrer PORTOLA Phase 2a-Studie angekündigt, die Zetomipzomib zur Behandlung von Autoimmunhepatitis (AIH) bewertet. Die Präsentation ist für 25. März 2025, um 8:00 Uhr ET angesetzt.

Die PORTOLA-Studie ist eine placebokontrollierte, randomisierte, doppelblinde Phase 2a-Studie, die die Wirksamkeit und Sicherheit von Zetomipzomib bei AIH-Patienten untersucht. Die Veranstaltung wird Präsentationen von wichtigen Forschern, darunter Dr. Craig Lammert von der Indiana University School of Medicine und Dr. Gideon Hirschfield vom Toronto General Hospital, gefolgt von einer Frage-und-Antwort-Runde, beinhalten.

Die Präsentation wird über einen Live-Audio-Webcast mit Folien zugänglich sein, und eine Wiederholung wird 90 Tage lang auf der Website des Unternehmens verfügbar sein.

Positive
  • Phase 2a trial completion indicates progress in drug development pipeline
  • Involvement of prominent medical investigators adds credibility to the trial
Negative
  • None.

SOUTH SAN FRANCISCO, CALIF.--(BUSINESS WIRE)-- Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases, today announced that it will present topline results from the PORTOLA Phase 2a trial evaluating zetomipzomib for the treatment of patients with autoimmune hepatitis (AIH) on Tuesday, March 25, 2025, at 8:00 a.m. ET.

The event will highlight topline data from Kezar’s PORTOLA trial, a placebo-controlled, randomized, double-blind Phase 2a clinical trial evaluating the efficacy and safety of zetomipzomib in patients with AIH. Additionally, the event will feature presentations from Craig Lammert, MD, Associate Professor of Medicine at Indiana University School of Medicine and a principal investigator on the PORTOLA trial, and Gideon Hirschfield, PhD, the Lily and Terry Horner Chair in Autoimmune Liver Disease Research, and Director of the Francis Family Liver Clinic at Toronto General Hospital.

A live question and answer session will follow the formal presentation.

To access the live audio webcast with slides and dial-in information as needed, please register here: https://kezar-life-sciences-portola-phase-2a-topline-results.open-exchange.net/.

A live webcast of the event can also be found on the Kezar website at https://ir.kezarlifesciences.com/news-events/events-presentations. A replay of the event will be available for 90 days following the presentation.

About PORTOLA

PORTOLA is a placebo-controlled, randomized, double-blind Phase 2a clinical trial evaluating the efficacy and safety of zetomipzomib in patients with AIH that are insufficiently responding to standard of care or have relapsed. The study has completed enrollment of 24 patients, randomized (2:1) to receive 60 mg of zetomipzomib or placebo in addition to background therapy for 24 weeks, with a protocol-suggested steroid taper. The primary efficacy endpoint will measure the proportion of patients who achieve a complete biochemical response by Week 24 measured as normalization of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and Immunoglobulin G (IgG) values (if elevated at baseline), with steroid dose levels not higher than baseline.

About Craig Lammert, MD

Craig Lammert, M.D., a clinician investigator who focuses on autoimmune hepatitis (AIH), is an Associate Professor of Medicine at Indiana University School of Medicine and also serves as the executive director for the Autoimmune Hepatitis Association (AIHA).

He has focused his research in AIH to better understand the genetic and environmental contributions to AIH and how these could modify outcomes of AIH patients. Dr. Lammert is the principal investigator of the Genetic Repository of Autoimmune Liver Disease and Contributing Exposures (GRACE) Study, a program historically funded by the National Institutes of Health (NIH) to build a database of AIH patients that includes disease phenotypes and outcomes, biologic samples, and environmental exposures.

He has been a strong advocate and supporter of AIH patients beyond the clinic and research realm. Through the AIHA, a US led non-profit organization with international membership of over 9,000 members that he created 13 years ago, he leads patient education conferences, research study recruitment, and support groups for AIH patients. He is an active member of the International Autoimmune Hepatitis Group and the American Association for the Study of Liver Diseases where he currently serves as the vice chairmen for the cholestatic and autoimmune liver disease special interest group. He also is a co-investigator in autoimmune liver disease drug trials and multicenter studies.

About Gideon Hirschfield, MD

Dr Gideon Hirschfield is the Lily and Terry Horner Chair in Autoimmune Liver Disease Research, and Director of the Francis Family Liver Clinic, Toronto General Hospital. He runs the Autoimmune and Rare Liver Disease Program at Toronto General Hospital and spends his time looking after people living with PBC, PSC, AIH and rare liver disease. Trained in the UK with prior faculty appointments in Birmingham, UK, he has developed a unique program in Toronto that encompasses care, teaching and research in the area of autoimmune and rare liver disease.

About Autoimmune Hepatitis

Autoimmune hepatitis (AIH) is a rare chronic disease in which the immune system attacks the liver and causes inflammation and tissue damage, severely impacting patients’ physical health and quality of life. Lifelong maintenance therapy is required to avoid relapse and burdensome adverse effects. If left untreated, AIH can lead to cirrhosis, liver failure and hepatocellular carcinoma. In the United States, AIH affects approximately 100,000 individuals, with incidence rates increasing. The cause of this condition remains unclear, with females affected four times as often as males. Currently, standard of care treatment for AIH is chronic, immunosuppressive treatment with corticosteroids that frequently cause life-altering side effects, including diabetes, osteoporotic fractures and cataracts. There is a significant need for treatment regimens that reduce or remove the need for chronic immunosuppression from using corticosteroids.

About Kezar Life Sciences

Kezar Life Sciences is a clinical-stage biopharmaceutical company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases. Zetomipzomib, a selective immunoproteasome inhibitor, is currently being evaluated in a Phase 2a clinical trial for autoimmune hepatitis. This product candidate also has the potential to address multiple chronic immune-mediated diseases. For more information, visit www.kezarlifesciences.com, and follow us on LinkedIn, Facebook, Twitter and Instagram.

Cautionary Note on Forward-looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “can,” “should,” “expect,” “believe,” “potential,” “anticipate” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Kezar’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Kezar’s clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the design, initiation, progress, timing, scope and results of clinical trials, the enrollment and expected timing of reporting topline data from our clinical trials, the likelihood that data will support future development and therapeutic potential, the association of data with treatment outcomes and the likelihood of obtaining regulatory approval of Kezar’s product candidates. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during clinical studies, difficulties enrolling and conducting our clinical trials, changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Kezar’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” contained therein. Except as required by law, Kezar assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Investor and Media Contact:

Gitanjali Jain

Senior Vice President, Investor Relations and External Affairs

Kezar Life Sciences, Inc.

gjain@kezarbio.com

Source: Kezar Life Sciences, Inc.

FAQ

When will Kezar Life Sciences (KZR) release the PORTOLA Phase 2a trial results?

Kezar Life Sciences will present the PORTOLA Phase 2a trial results on March 25, 2025, at 8:00 a.m. ET.

What is the design of KZR's PORTOLA trial for autoimmune hepatitis?

PORTOLA is a placebo-controlled, randomized, double-blind Phase 2a clinical trial evaluating zetomipzomib's efficacy and safety in autoimmune hepatitis patients.

Who are the key investigators presenting KZR's PORTOLA trial results?

Dr. Craig Lammert from Indiana University School of Medicine and Dr. Gideon Hirschfield from Toronto General Hospital will present the results.

How can investors access KZR's PORTOLA trial results presentation?

Investors can access the presentation via live audio webcast through Kezar's website or by registering at the provided link. A replay will be available for 90 days.
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