Zura Bio Announces Submission of Protocol to U.S. Food and Drug Administration for the Phase 2 Study of Tibulizumab in Adults with Systemic Sclerosis
Zura Bio (Nasdaq: ZURA) has submitted a protocol to the FDA for a Phase 2 study of tibulizumab, a dual-pathway antibody targeting IL-17A and BAFF, for treating systemic sclerosis in adults. The planned double-blind, randomized study will evaluate safety, tolerability, and efficacy in approximately 80 participants with early diffuse cutaneous systemic sclerosis. The trial aims to demonstrate improvements in skin and lung symptoms and includes an open-label extension. Expected to begin in Q4 2024, the company has already submitted an Orphan Drug Designation request to the FDA.
Zura Bio (Nasdaq: ZURA) ha presentato un protocollo alla FDA per uno studio di Fase 2 su tibulizumab, un anticorpo a doppio percorso che mira a IL-17A e BAFF, per il trattamento della sclerosi sistemica negli adulti. Lo studio, progettato come multicentrico, in doppio cieco e randomizzato, valuterà la sicurezza, la tollerabilità e l'efficacia in circa 80 partecipanti con sclerosi sistemica cutanea diffusa precoce. L'obiettivo della sperimentazione è dimostrare miglioramenti nei sintomi cutanei e polmonari e include un'estensione in aperto. Si prevede che inizi nel quarto trimestre del 2024 e l'azienda ha già presentato una richiesta di designazione di farmaco orfano alla FDA.
Zura Bio (Nasdaq: ZURA) ha presentado un protocolo a la FDA para un estudio de Fase 2 sobre tibulizumab, un anticuerpo de doble vía dirigido a IL-17A y BAFF, para el tratamiento de la esclerosis sistémica en adultos. El estudio planificado será doble ciego, aleatorio y evaluará la seguridad, tolerabilidad y eficacia en aproximadamente 80 participantes con esclerosis sistémica cutánea difusa temprana. El ensayo tiene como objetivo demostrar mejoras en los síntomas de la piel y los pulmones e incluye una extensión abierta. Se espera que comience en el cuarto trimestre de 2024, y la empresa ya ha presentado una solicitud de designación de medicamento huérfano a la FDA.
Zura Bio (Nasdaq: ZURA)는 성인 전신 경화증 치료를 위한 IL-17A와 BAFF를 표적하는 이중 경로 항체인 tibulizumab에 대한 2상 연구 프로토콜을 FDA에 제출했습니다. 계획된 이중 맹검, 무작위 연구는 초기 확산성 피부 전신 경화증을 가진 약 80명의 참가자를 대상으로 안전성, 내약성 및 유효성을 평가합니다. 이 시험은 피부 및 폐 증상의 개선을 입증하고 공개 라벨 연장을 포함하는 것을 목표로 합니다. 2024년 4분기에 시작될 예정이며, 회사는 이미 FDA에 고아 약물 지정 요청을 제출했습니다.
Zura Bio (Nasdaq: ZURA) a soumis un protocole à la FDA pour une étude de phase 2 sur tibulizumab, un anticorps à double action ciblant l'IL-17A et le BAFF, pour le traitement de la sclérose systémique chez les adultes. L'étude randomisée en double aveugle prévue évaluera la sécurité, la tolérance et l'efficacité auprès d'environ 80 participants atteints de sclérose systémique cutanée diffuse précoce. L'essai vise à démontrer des améliorations des symptômes cutanés et pulmonaires et comprend une extension en ouvert. Il devrait débuter au quatrième trimestre 2024, et la société a déjà soumis une demande de désignation de médicament orphelin à la FDA.
Zura Bio (Nasdaq: ZURA) hat ein Protokoll bei der FDA für eine Phase-2-Studie zu tibulizumab, einem dualen Antikörper, der auf IL-17A und BAFF abzielt, zur Behandlung von systemischer Sklerose bei Erwachsenen eingereicht. Die geplante doppelblinde, randomisierte Studie wird die Sicherheit, Verträglichkeit und Wirksamkeit bei etwa 80 Teilnehmern mit früher diffuser kutaner systemischer Sklerose bewerten. Die Studie hat zum Ziel, Verbesserungen bei Haut- und Lungensymptomen zu zeigen und umfasst eine offene Verlängerung. Der Beginn ist für das vierte Quartal 2024 geplant, und das Unternehmen hat bereits einen Antrag auf Orphan Drug Designation bei der FDA eingereicht.
- Protocol submission to FDA for Phase 2 trial represents regulatory progress
- Potential first-in-class dual-pathway treatment approach
- Targeting an unmet medical need in systemic sclerosis
- Orphan Drug Designation request submitted
- Product not yet approved by any regulatory authority
- Clinical trial won't start until Q4 2024
- Safety and efficacy not yet established
Insights
The protocol submission for tibulizumab's Phase 2 trial represents a significant milestone in addressing the complex pathology of systemic sclerosis. The dual-targeting mechanism against both IL-17A and BAFF is particularly noteworthy, as it simultaneously addresses inflammation and fibrosis - two critical disease pathways that current treatments don't fully target.
The trial design with 80 participants and 1:1 randomization is robust for a Phase 2 study in a rare disease. The focus on early diffuse cutaneous systemic sclerosis (dcSSc) is strategic, as early intervention may lead to better outcomes. The planned Q4 2024 initiation, coupled with the pending Orphan Drug Designation, could accelerate the development timeline.
However, investors should note that Phase 2 trials typically have a
“Systemic sclerosis presents significant unmet needs, as current treatments largely target only its interstitial lung disease (ILD) component,” said Robert Lisicki, CEO of Zura Bio. “Tibulizumab, with dual IL-17A and BAFF inhibition, offers a potential first-in-class approach addressing both immune dysregulation and fibrosis—key drivers of the disease. This study protocol reflects our commitment to advancing therapies that could potentially bring meaningful improvements for those affected by systemic sclerosis.”
The planned Phase 2 clinical trial, a double-blind, randomized (1:1), placebo-controlled study, is designed to evaluate the safety, tolerability, and efficacy of tibulizumab in approximately 80 participants with early diffuse cutaneous systemic sclerosis (dcSSc). The anticipated study aims to demonstrate improvements in skin and lung symptoms, two primary complications of SSc, and includes an open-label extension. The trial is expected to initiate in Q4 2024, with an Orphan Drug Designation request already submitted to the FDA in the same quarter.
Tibulizumab has not received approval from any regulatory authority, and its safety and efficacy for the treatment of SSc have not been established.
ABOUT SYSTEMIC SCLEROSIS
Systemic sclerosis (SSc), also known as scleroderma, is a rare, life-threatening autoimmune disease affecting approximately 300,000 individuals worldwide, including around 100,000 in
There remains a high unmet medical need due to the limited treatment options available for individuals living with SSc. Currently, only two disease-modifying therapies are FDA-approved for severe lung complications of the disease (i.e., SSc-ILD), and no effective treatment exists that addresses the disease across multiple organ systems.
ABOUT TIBULIZUMAB
Tibulizumab, an investigational humanized, tetravalent bispecific dual-antagonist antibody, is a fusion of Taltz® (ixekizumab) and tabalumab, engineered to bind to and neutralize both IL-17A and BAFF. Tibulizumab is expected to enter Phase 2 clinical development for the treatment of systemic sclerosis in Q4 2024 and for the treatment of hidradenitis suppurativa in Q2 2025. Before in-licensing, Phase 1/1b studies of tibulizumab were conducted in Sjögren’s syndrome and rheumatoid arthritis.
ABOUT ZURA BIO
Zura Bio is a clinical-stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases. Currently, Zura Bio is developing three assets which have completed Phase 1/1b studies. The company is developing a portfolio of therapeutic indications for tibulizumab (ZB-106), crebankitug (ZB-168), and torudokimab (ZB-880), with a goal of demonstrating their efficacy, safety, and dosing convenience in autoimmune and inflammatory diseases, including systemic sclerosis and other novel indications with unmet needs.
FORWARD-LOOKING STATEMENTS
This communication includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believe,” “predict,” “potential,” “continue,” “strategy,” “future,” “opportunity,” “would,” “seem,” “seek,” “outlook,” “goal,” “mission,” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties that could cause the actual results to differ materially from the expected results. These statements are based on various assumptions, whether or not identified in this communication. These forward-looking statements in this release include, but are not limited to, statements regarding: Zura Bio’s forecasts, including with respect to business strategies and objectives; the potential of Zura Bio’s product candidates; and expectations with respect to Zura Bio’s development program, including regulatory matters, clinical trials and the design and timing thereof. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability.
Actual events are difficult or impossible to predict and could differ materially from those expressed or implied in such forward-looking statements, as a result of these risks and uncertainties, which include, but are not limited to: Zura Bio’s expectations regarding its product candidates and their related benefits, and Zura Bio’s beliefs regarding competing product candidates and products both in development and approved, may not be achieved; Zura Bio's vision and strategy may not be successful; the timing of key events and initiation of Zura Bio's studies, regulatory matters and release of clinical data may take longer than anticipated or may not be achieved at all; the potential general acceptability and maintenance of Zura Bio's product candidates by regulatory authorities, payors, physicians, and patients may not be achieved; Zura Bio's ability to attract and retain key personnel; Zura Bio's expectations with respect to its future operating expenses, capital requirements and needs for additional financing may not be achieved; Zura Bio has not completed any clinical trials, and has no products approved for commercial sale; Zura Bio has incurred significant losses since inception, and expects to incur significant losses for the foreseeable future and may not be able to achieve or sustain profitability in the future; Zura Bio requires substantial additional capital to finance its operations, and if it is unable to raise such capital when needed or on acceptable terms, Zura Bio may be forced to delay, reduce, and/or eliminate one or more of its development programs or future commercialization efforts; Zura Bio may be unable to renew existing contracts or enter into new contracts; Zura Bio relies on third-party contract development manufacturing organizations for the manufacture of clinical materials; Zura Bio relies on contract research organizations, clinical trial sites, and other third parties to conduct of its preclinical studies and clinical trials; Zura Bio may be unable to obtain regulatory approval for its product candidates, and there may be related restrictions or limitations of any approved products; Zura Bio may be unable to successfully respond to general economic and geopolitical conditions; Zura Bio may be unable to effectively manage growth; Zura Bio faces competitive pressures from other companies worldwide; Zura Bio may be unable to adequately protect its intellectual property rights; and other factors set forth in documents filed, or to be filed by Zura Bio, with the Securities and Exchange Commission (SEC), including the risks and uncertainties described in the “Risk Factors” section of Zura Bio's Annual Report on Form 10-K for the year ended December 31, 2023 and other filings with the SEC. These risks and uncertainties may be amplified by health epidemics or other unanticipated global disruption events, which may continue to cause economic uncertainty. Zura Bio cautions that the foregoing list of factors is not exclusive or exhaustive and not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Zura Bio gives no assurance that it will achieve its expectations. Zura Bio does not undertake or accept any obligation to update any forward-looking statements, except as required by law.
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Megan K. Weinshank
Head of Corporate Affairs
ir@zurabio.com
Source: Zura Bio Limited
FAQ
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