Incyte Provides Update on Early Phase MRGPRX2 and MRGPRX4 Programs
Incyte (INCY) announced the pause of enrollment in its Phase 2 study of MRGPRX2 (INCB000262) in chronic spontaneous urticaria due to preclinical toxicology findings. The company will collaborate with the FDA to determine next steps. While enrollment in other INCB000262 proof-of-concept studies is complete, the data will inform future development decisions and guide potential back-up molecule development. Additionally, Phase 2 study results for MRGPRX4 (INCB000547) in cholestatic pruritus were unfavorable, leading to discontinuation of its development.
Incyte (INCY) ha annunciato la sospensione dell'arruolamento nel suo studio di Fase 2 su MRGPRX2 (INCB000262) per l'orticaria spontanea cronica a causa di risultati tossicologici preclinici. L'azienda collaborerà con la FDA per determinare i prossimi passi. Sebbene l'arruolamento in altri studi di prova-concetto di INCB000262 sia completo, i dati informeranno future decisioni di sviluppo e guideranno il potenziale sviluppo di molecole di riserva. Inoltre, i risultati dello studio di Fase 2 per MRGPRX4 (INCB000547) nel prurito colestatico sono stati sfavorevoli, portando alla discontinuazione del suo sviluppo.
Incyte (INCY) anunció la pausa del enrolamiento en su estudio de Fase 2 sobre MRGPRX2 (INCB000262) en urticaria crónica espontánea debido a hallazgos de toxicología preclínica. La compañía colaborará con la FDA para determinar los próximos pasos. Aunque el enrolamiento en otros estudios de prueba de concepto de INCB000262 está completo, los datos informarán futuras decisiones de desarrollo y guiarán el potencial desarrollo de moléculas alternativas. Además, los resultados del estudio de Fase 2 para MRGPRX4 (INCB000547) en prurito colestático fueron desfavorables, lo que llevó a la discontinuación de su desarrollo.
Incyte (INCY)는 전임상 독성학 결과로 인해 만성 자발성 두드러기에서 MRGPRX2 (INCB000262)에 대한 2상 연구의 등록을 일시 중지한다고 발표했습니다. 회사는 FDA와 협력하여 다음 단계를 결정할 것입니다. INCB000262의 다른 개념 증명 연구에 대한 등록은 완료되었으며, 수집된 데이터는 향후 개발 결정에 정보를 제공하고 잠재적인 백업 분자 개발을 안내할 것입니다. 또한, MRGPRX4 (INCB000547)의 2상 연구 결과는 불리하여 개발이 중단되었습니다.
Incyte (INCY) a annoncé la suspension du recrutement dans son étude de phase 2 concernant MRGPRX2 (INCB000262) dans l'urticaire chronique spontanée en raison de résultats de toxicologie préclinique. La société collaborera avec la FDA pour déterminer les prochaines étapes. Bien que le recrutement dans d'autres études de preuve de concept sur INCB000262 soit complet, les données informeront les futures décisions de développement et guideront le développement potentiel de molécules de secours. De plus, les résultats de l'étude de phase 2 concernant MRGPRX4 (INCB000547) dans le prurit cholestatique étaient défavorables, ce qui a conduit à l'arrêt de son développement.
Incyte (INCY) gab die Unterbrechung der Rekrutierung in seiner Phase-2-Studie zu MRGPRX2 (INCB000262) bei chronischer spontaner Urtikaria aufgrund von präklinischen Toxikologie-Ergebnissen bekannt. Das Unternehmen wird mit der FDA zusammenarbeiten, um die nächsten Schritte zu bestimmen. Obwohl die Rekrutierung in anderen INCB000262-Beweis-der-Konzept-Studien abgeschlossen ist, werden die Daten zukünftige Entwicklungsentscheidungen informieren und die potenzielle Entwicklung von Backup-Molekülen steuern. Darüber hinaus waren die Ergebnisse der Phase-2-Studie zu MRGPRX4 (INCB000547) bei cholestatischem Pruritus ungünstig und führten zur Einstellung seiner Entwicklung.
- Enrollment completion in other INCB000262 proof-of-concept studies
- Pause in Phase 2 MRGPRX2 study enrollment due to toxicology concerns
- Unfavorable Phase 2 results leading to discontinuation of MRGPRX4 development
- Potential delays and additional costs in drug development pipeline
Insights
The pause in MRGPRX2's Phase 2 trial for chronic spontaneous urticaria due to toxicology findings represents a significant setback for Incyte's pipeline. The discovery of safety concerns at this stage typically requires extensive investigation and could potentially lead to program termination. Additionally, the failure of MRGPRX4 in cholestatic pruritus further compounds the negative impact on Incyte's dermatology and pruritus portfolio.
These developments affect two key programs in Incyte's early-phase pipeline, potentially creating gaps in their future product lineup. The toxicology findings for MRGPRX2 are particularly concerning as they emerged after clinical trials had begun, raising questions about the program's viability. The market for CSU treatments is substantial, with current options including Xolair and other biologics, making this setback more impactful for Incyte's growth prospects.
These data have been shared with the
Enrollment in the other INCB000262 proof-of-concept studies is complete and data from all clinical studies will help inform its future development and guide the potential development of back-up molecules.
In addition, data from the Phase 2 study evaluating MRGPRX4 (INCB000547) in cholestatic pruritus (CP) does not support further development.
About Incyte
A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in
For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube.
Forward-Looking Statements
Except for the historical information set forth herein, the matters set forth in this press release contain predictions, estimates and other forward-looking statements, including any discussion of the ongoing Phase 2 study of MRGPRX2 (INCB000262), Incyte’s decision to pause enrollment in that study, Incyte’s intent to work with FDA to determine next steps, and future development of INCB000262 and other back-up molecules.
These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: further research and development and the possibility that results of clinical trials will be negative and/or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; determinations made by FDA and other regulatory agencies; the efficacy or safety of Incyte’s products; the acceptance of Incyte’s products in the marketplace; market competition; unexpected variations in the supply of and/or demand for Incyte’s products; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for Incyte’s products; sales, marketing, manufacturing and distribution requirements, including Incyte’s ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional products that become approved; greater than expected expenses, including expenses relating to litigation or strategic activities; variations in foreign currency exchange rates; and other risks detailed in Incyte’s reports filed with the Securities and Exchange Commission, including its quarterly report on form 10-Q for the quarter ended September 30, 2024. Incyte disclaims any intent or obligation to update these forward-looking statements.
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FAQ
Why did Incyte (INCY) pause the Phase 2 MRGPRX2 study?
What happened to Incyte's (INCY) MRGPRX4 drug development program?
What is the status of other INCB000262 studies by Incyte (INCY)?
