Aurinia Announces First Participant Dosed in AUR200 Single Ascending Dose Trial
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) has announced the dosing of the first participant in a Phase 1a single ascending dose (SAD) study of AUR200, a potential best-in-class therapy for autoimmune diseases. AUR200 targets both BAFF and APRIL, and is believed to be more potent with higher binding affinity compared to similar molecules. The study aims to assess safety, tolerability, pharmacokinetics, and biomarker changes in healthy volunteers, with data expected in the first half of 2025.
Aurinia plans to develop AUR200 for diseases with few market entrants, including one larger indication and one smaller indication meeting FDA criteria for orphan and rare diseases. The company will fund this development using available cash flow, without impacting post-restructuring operating expense targets.
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) ha annunciato la somministrazione della prima dose al partecipante in un studio di fase 1a con somministrazione di dose singola (SAD) di AUR200, una potenziale terapia di punta per le malattie autoimmuni. AUR200 agisce su entrambi, BAFF e APRIL, ed è ritenuto più potente con una maggiore affinità di legame rispetto a molecole simili. Lo studio mira a valutare la sicurezza, la tollerabilità, la farmacocinetica e le variazioni dei biomarker in volontari sani, con dati attesi nella prima metà del 2025.
Aurinia prevede di sviluppare AUR200 per malattie con pochi concorrenti nel mercato, inclusa una suddivisione più ampia e una più piccola che soddisfi i criteri FDA per malattie orfane e rare. L'azienda finanzierà questo sviluppo utilizzando il flusso di cassa disponibile, senza impattare sugli obiettivi di spesa operativa post-ristrutturazione.
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) ha anunciado la dosificación del primer participante en un estudio de fase 1a de dosis única ascendente (SAD) de AUR200, una posible terapia líder para enfermedades autoinmunes. AUR200 se dirige tanto a BAFF como a APRIL, y se cree que es más potente con una mayor afinidad de unión en comparación con moléculas similares. El estudio pretende evaluar la seguridad, la tolerancia, la farmacocinética y los cambios en los biomarcadores en voluntarios sanos, con datos esperados en la primera mitad de 2025.
Aurinia planea desarrollar AUR200 para enfermedades con pocos competidores en el mercado, incluyendo una indicación más grande y una indicación más pequeña que cumpla con los criterios de la FDA para enfermedades huérfanas y raras. La empresa financiará este desarrollo utilizando el flujo de caja disponible, sin afectar los objetivos de gastos operativos posteriores a la reestructuración.
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH)는 AUR200의 1상 단일 상승 용량(SAD) 연구에 첫 번째 참가자의 투여를 발표했습니다. AUR200은 자가 면역 질환에 대한 잠재적인 최선의 치료제로, BAFF와 APRIL 모두를 목표로 하며 유사한 분자에 비해 더 강력하고 높은 결합 친화력을 갖는 것으로 알려져 있습니다. 이 연구는 건강한 자원봉사자에서 안전성, 내약성, 약동학 및 바이오마커 변화를 평가하는 것을 목표로 하며, 2025년 상반기 데이터가 예상됩니다.
Aurinia는 시장에 진입한 경쟁자가 적은 질병을 위한 AUR200 개발을 계획하고 있으며, 여기에 FDA의 고아 및 희귀 질환 기준을 충족하는 하나의 대규모 적응증과 소규모 적응증이 포함됩니다. 회사는 가용 현금 흐름을 활용하여 이 개발을 자금 조달할 계획이며, 재구성 이후 운영 비용 목표에는 영향을 주지 않을 것입니다.
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) a annoncé l'administration de la première dose au participant d'une étude de phase 1a sur la dose unique ascendante (SAD) de AUR200, une thérapie potentiellement de premier plan pour les maladies auto-immunes. AUR200 cible à la fois BAFF et APRIL, et il est considéré comme plus puissant avec une affinité de liaison plus élevée par rapport à des molécules similaires. L'étude vise à évaluer la sécurité, la tolérance, la pharmacocinétique et les changements de biomarqueurs chez des volontaires en bonne santé, avec des données attendues dans la première moitié de 2025.
Aurinia prévoit de développer AUR200 pour des maladies avec peu d'entrées sur le marché, y compris une indication plus grande et une plus petite qui répond aux critères de la FDA pour les maladies orphelines et rares. L'entreprise financera ce développement en utilisant le flux de trésorerie disponible, sans impacter les objectifs de dépenses opérationnelles après restructuration.
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) hat die Dosisverabreichung des ersten Teilnehmers in einer Phase 1a-Studie mit steigenden Einzel-Dosen (SAD) für AUR200 bekannt gegeben, einer potenziellen Spitzenbehandlung für Autoimmunerkrankungen. AUR200 zielt sowohl auf BAFF als auch auf APRIL und wird für potenter gehalten mit einer höheren Bindungsaffinität im Vergleich zu ähnlichen Molekülen. Die Studie zielt darauf ab, Sicherheit, Verträglichkeit, Pharmakokinetik und Biomarker-Veränderungen bei gesunden Freiwilligen zu bewerten, wobei Daten in der ersten Hälfte des Jahres 2025 erwartet werden.
Aurinia plant, AUR200 für Krankheiten mit wenigen Marktteilnehmern zu entwickeln, darunter ein größeres und ein kleineres Indikationsgebiet, das die FDA-Kriterien für orphan und seltene Krankheiten erfüllt. Das Unternehmen wird diese Entwicklung mithilfe des verfügbaren Cashflows finanzieren, ohne die betrieblichen Ausgaben nach der Restrukturierung zu beeinträchtigen.
- First participant dosed in Phase 1a single ascending dose study for AUR200
- AUR200 potentially a best-in-class therapy for autoimmune diseases
- AUR200 believed to be more potent with higher binding affinity than similar molecules
- Development to focus on diseases with few market entrants
- Funding from available cash flow, not impacting post-restructuring expense targets
- Data from the Phase 1a study not expected until first half of 2025
- Specific indications and development plans not yet communicated
Insights
The initiation of the Phase 1a single ascending dose (SAD) study for AUR200 marks a significant milestone in Aurinia's pipeline development. This novel dual-targeting therapy aims to inhibit both BAFF and APRIL, key factors in B-cell-mediated autoimmune diseases. The potential for AUR200 to be a best-in-class treatment is noteworthy, especially given the claimed higher potency and binding affinity compared to similar molecules.
However, investors should note that data is not expected until the first half of 2025, indicating a long timeline before potential commercialization. The company's strategy to target both a larger indication and a smaller, orphan disease is prudent, potentially balancing market size with faster regulatory pathways. The use of existing cash flow for development, without impacting post-restructuring expense targets, suggests efficient financial management.
From a financial perspective, Aurinia's approach with AUR200 appears strategically sound. By leveraging existing cash flow for development without altering expense targets, the company demonstrates fiscal discipline. The dual-pronged indication strategy could potentially maximize return on investment by balancing market size with development speed.
However, investors should be cautious about the extended timeline to data readout in 2025, which may impact short-term stock performance. The lack of specific indication targets at this stage also introduces uncertainty. While the potential for a best-in-class therapy is promising, it's important to monitor the competitive landscape and any interim updates that might affect the company's market position and valuation.
The SAD study will assess the safety, tolerability, pharmacokinetics, and changes in biomarkers for AUR200 in healthy volunteers, with data expected in the first half of 2025.
“The start of the single ascending dose study is an important milestone for developing AUR200, which has the potential to serve as a best-in-class treatment in autoimmune diseases with high unmet need. We believe AUR200 is a more potent compound with a higher binding affinity compared to the two other TACI-Fc molecules designed to bind both BAFF and APRIL that were tested in our preclinical research. We expect the data from this early-stage study to provide key points of differentiation that will inform further clinical development efforts,” said Dr. Greg Keenan, Chief Medical Officer of Aurinia.
The Company intends to develop AUR200 in disease states where there are currently few market entrants, including one larger indication and one fast-to-market smaller indication that meets the FDA criteria for orphan and rare diseases. The Company will communicate specific indications and development plans pending progress and outcomes of early-stage clinical trials and based on ongoing assessment of the competitive landscape in relevant indications. The Company anticipates funding this development program with available cash flow, which is not anticipated to impact previously announced post-restructuring operating expense targets.
About AUR200
AUR200, a highly potent and specific immune modulator, is an IgG4 Fc-fusion protein with no appreciable effector function. AUR200 contains a unique, structurally engineered B-cell maturation antigen (BCMA) domain for enhanced binding to both BAFF and APRIL, two cytokines that play important roles in regulating B-cell survival and differentiation. Dual inhibition of BAFF and APRIL is a clinically validated mechanism that has demonstrated great therapeutic potential for a wide range of autoimmune diseases.
In animal data presented at the annual American College of Rheumatology Convergence 2022, AUR200 dosed therapeutically reduced several markers of disease activity and improved overall survival in a mouse model of lupus. AUR200 was also well-tolerated in both mice and cynomolgus monkeys, with no adverse effects. These findings highlight the potential value of AUR200 in the treatment of autoimmune diseases.i
About Aurinia
Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA-approved oral therapy dedicated to the treatment of adult patients with active lupus nephritis. The Company’s head office is in
Forward-Looking Statements
Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable
Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance, or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: Aurinia’s actual future financial and operational results may differ from its expectations; Aurinia may have to pay unanticipated expenses; the future prospects for AUR200 may not be as Aurinia has anticipated, or Aurinia may not be able to fully capitalize on the opportunities presented by AUR200; and Aurinia’s third party service providers may not, or may not be able to, comply with their obligations under their agreements with Aurinia. Although Aurinia has attempted to identify factors that would cause actual actions, events, or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements, or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond Aurinia’s control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.
All forward-looking information contained in this press release is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia’s most recent Annual Report on Form 10-K available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedarplus.ca or the
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i Morales S, Cross J, Huizinga R. AUR200: An Improved BAFF/APRIL Inhibitor with Increased Potency and Safety for the Treatment of B Cell-Mediated Diseases [abstract]. Arthritis Rheumatol. 2022; 74 (suppl 9). https://acrabstracts.org/abstract/aur200-an-improved-baff-april-inhibitor-with-increased-potency-and-safety-for-the-treatment-of-b-cell-mediated-diseases/. Accessed December 6, 2023.
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Media & Investor Inquiries:
Andrea Christopher,
Corporate Communications & Investor Relations, Aurinia
achristopher@auriniapharma.com
General Investor Inquiries:
ir@auriniapharma.com
Source: Aurinia Pharmaceuticals Inc.
FAQ
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