Kezar Life Sciences Announces Clinical Hold of Zetomipzomib IND for Treatment of Lupus Nephritis
Kezar Life Sciences (Nasdaq: KZR) announced that the FDA has placed a clinical hold on the zetomipzomib Investigational New Drug (IND) application for the treatment of lupus nephritis (LN). This follows Kezar's voluntary suspension of enrollment and dosing in its Phase 2b PALIZADE clinical trial of zetomipzomib in LN patients, based on the recommendation of the trial's Independent Data Monitoring Committee (IDMC).
The IDMC's recommendation came after reviewing emerging safety data, including four Grade 5 (fatal) serious adverse events (SAEs) in patients enrolled in the Philippines and Argentina. The FDA will provide an official clinical hold letter within 30 days. Kezar's CEO, Chris Kirk, emphasized their commitment to patient safety and ongoing investigation of these cases.
The zetomipzomib IND for autoimmune hepatitis remains unaffected, with the Phase 2a PORTOLA clinical trial continuing without any Grade 4 or 5 SAEs observed to date.
Kezar Life Sciences (Nasdaq: KZR) ha annunciato che la FDA ha posto un blocco clinico sull'applicazione per il Nuovo Farmaco Investigativo (IND) di zetomipzomib per il trattamento della nefrite lupica (LN). Questo segue la sospensione volontaria da parte di Kezar dell'arruolamento e della somministrazione nel suo trial clinico di Fase 2b PALIZADE di zetomipzomib in pazienti con LN, basata sulla raccomandazione del Comitato Indipendente di Monitoraggio dei Dati (IDMC) dello studio.
La raccomandazione dell'IDMC è arrivata dopo aver esaminato i dati di sicurezza emergenti, inclusi quattro eventi avversi gravi di grado 5 (fatali) (SAE) in pazienti arruolati nelle Filippine e in Argentina. La FDA fornirà una lettera ufficiale di blocco clinico entro 30 giorni. Il CEO di Kezar, Chris Kirk, ha ribadito il loro impegno per la sicurezza dei pazienti e l'ulteriore indagine su questi casi.
L'IND di zetomipzomib per epatite autoimmune rimane non influenzato, con il trial clinico di Fase 2a PORTOLA che continua senza la registrazione di eventi avversi gravi di grado 4 o 5 fino ad oggi.
Kezar Life Sciences (Nasdaq: KZR) anunció que la FDA ha impuesto un bloqueo clínico en la solicitud de Nuevo Medicamento Investigacional (IND) para zetomipzomib en el tratamiento de nefritis lúpica (LN). Esto sigue a la suspensión voluntaria de Kezar de la inscripción y la dosificación en su ensayo clínico Fase 2b PALIZADE de zetomipzomib en pacientes con LN, basada en la recomendación del Comité Independiente de Monitoreo de Datos (IDMC) del ensayo.
La recomendación del IDMC se produjo después de revisar los datos de seguridad emergentes, incluidos cuatro eventos adversos graves de Grado 5 (fatales) (SAE) en pacientes inscritos en Filipinas y Argentina. La FDA proporcionará una carta oficial de bloqueo clínico dentro de 30 días. El CEO de Kezar, Chris Kirk, enfatizó su compromiso con la seguridad del paciente y la investigación continua de estos casos.
El IND de zetomipzomib para hepatitis autoinmune permanece sin cambios, con el ensayo clínico de Fase 2a PORTOLA continuando sin que se hayan observado eventos adversos graves de Grado 4 o 5 hasta la fecha.
Kezar Life Sciences (Nasdaq: KZR)는 FDA가 zetomipzomib의 임상 보류를 발표했다고 밝혔습니다. 이는 루푸스 신염 (LN) 치료를 위한 새로운 의약품 조사 (IND) 신청에 대한 것입니다. 이는 Kezar가 IDMC의 권고에 따라 LN 환자를 대상으로 한 2b상 PALIZADE 임상 시험의 등록 및 투여를 자발적으로 중단한 결과입니다.
IDMC의 권고는 필리핀과 아르헨티나에서 등록된 환자들에서 발생한 네 건의 5등급(치명적인) 심각한 부작용 (SAE)을 포함한 새로운 안전성 데이터 검토 후 나왔습니다. FDA는 30일 이내에 공식적인 임상 보류 통지를 제공할 것입니다. Kezar의 CEO 크리스 커크는 환자 안전에 대한 그들의 헌신과 이러한 사건에 대한 지속적인 조사를 강조했습니다.
zetomipzomib의 자가면역성 간염에 대한 IND는 영향받지 않으며, 2a상 PORTOLA 임상 시험은 현재까지 4등급 또는 5등급 SAE가 관찰되지 않고 계속 진행됩니다.
Kezar Life Sciences (Nasdaq: KZR) a annoncé que la FDA a placé un arrêt clinique sur la demande de Nouveau Médicament Investigational (IND) pour le zetomipzomib dans le traitement de la néphrite lupique (LN). Cela fait suite à la suspension volontaire par Kezar de l'inscription et de l'administration dans son essai clinique de Phase 2b PALIZADE de zetomipzomib chez des patients souffrant de LN, sur la base des recommandations du Comité Indépendant de Surveillance des Données (IDMC) de l'essai.
La recommandation de l'IDMC est intervenue après examen des données de sécurité émergentes, y compris quatre événements indésirables graves de Grade 5 (fatals) (SAE) chez des patients inscrits aux Philippines et en Argentine. La FDA fournira une lettre officielle d'arrêt clinique dans les 30 jours. Le PDG de Kezar, Chris Kirk, a souligné leur engagement envers la sécurité des patients et l'enquête continue sur ces cas.
L'IND pour le zetomipzomib pour hépatite auto-immune reste inchangé, l'essai clinique de Phase 2a PORTOLA se poursuivant sans que des événements indésirables graves de Grade 4 ou 5 aient été observés jusqu'à présent.
Kezar Life Sciences (Nasdaq: KZR) gab bekannt, dass die FDA einen klinischen Halt auf den Antrag für das neue Arzneimittel (IND) von zetomipzomib zur Behandlung von Lupusnephritis (LN) verhängt hat. Dies folgt auf die freiwillige Aussetzung der Rekrutierung und Dosierung in Kezars Phase 2b PALIZADE-Studie zu zetomipzomib bei LN-Patienten, basierend auf der Empfehlung des unabhängigen Datenüberwachungskomitees (IDMC) der Studie.
Die Empfehlung des IDMC wurde nach der Überprüfung aufkommender Sicherheitsdaten ausgesprochen, einschließlich vier schwerwiegender unerwünschter Ereignisse der Grad 5 (tödlich) (SAEs) bei Patienten, die in den Philippinen und Argentinien eingeschlossen wurden. Die FDA wird innerhalb von 30 Tagen ein offizielles Schreiben zum klinischen Halt bereitstellen. Der CEO von Kezar, Chris Kirk, betonte ihr Engagement für die Sicherheit der Patienten und die fortlaufende Untersuchung dieser Fälle.
Der IND für zetomipzomib zur Behandlung von autoimmuner Hepatitis bleibt unverändert, und die klinische Studie der Phase 2a PORTOLA wird ohne bisher beobachtete schwerwiegende unerwünschte Ereignisse der Grade 4 oder 5 fortgesetzt.
- Phase 2a PORTOLA clinical trial for autoimmune hepatitis remains active
- No Grade 4 or 5 serious adverse events observed in the PORTOLA trial to date
- Clinical hold placed on zetomipzomib IND for lupus nephritis treatment
- Voluntary suspension of enrollment and dosing in Phase 2b PALIZADE clinical trial
- Four Grade 5 (fatal) serious adverse events reported in the PALIZADE trial
- Potential delay in zetomipzomib development for lupus nephritis
“We are steadfastly committed to patient safety and have directed our efforts to investigating these cases as we look to continue the zetomipzomib development program,” said Chris Kirk, PhD, Kezar’s Chief Executive Officer. “At this time, our zetomipzomib IND for the treatment of autoimmune hepatitis is unaffected. Our Phase 2a
About Lupus Nephritis
LN is one of the most serious complications of systemic lupus erythematosus (SLE). LN is a disease comprising a spectrum of vascular, glomerular and tubulointerstitial lesions and develops in approximately
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. 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 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 nature, frequency and severity of adverse events; the design, progress and outcome of Kezar’s clinical trials; the Company’s ability to complete its clinical trials on expected timelines, if at all; and the timing and outcome of regulatory submissions and actions by the FDA, EMA or any other regulatory agencies with respect to zetomipzomib or Kezar’s clinical trials. Many factors may cause differences between current expectations and actual results, including those factors that are discussed in Kezar’s filings with the
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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
What is the current status of Kezar Life Sciences' zetomipzomib IND for lupus nephritis?
Why did Kezar Life Sciences (KZR) suspend the Phase 2b PALIZADE clinical trial?
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Is Kezar's zetomipzomib trial for autoimmune hepatitis affected by the clinical hold?
