Omeros Corporation Announces Upcoming Presentations at ASH Annual Meeting
Omeros (NASDAQ: OMER) has announced two upcoming presentations about zaltenibart (OMS906), their investigational MASP-3 inhibitor, at the 66th Annual Meeting of the American Society of Hematology (ASH) in San Diego, December 7-10, 2024. The presentations focus on treating paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder.
The presentations include interim results from a Phase 2 proof-of-concept study showing improved hematologic parameters in PNH patients, and a pharmacokinetics/pharmacodynamics study. Phase 3 clinical trials for zaltenibart in PNH are scheduled to begin in early 2025.
Omeros (NASDAQ: OMER) ha annunciato due presentazioni imminenti riguardanti zaltenibart (OMS906), il loro inibitore sperimentale MASP-3, che si terranno durante il 66° Congresso Annuale della Società Americana di Ematologia (ASH) a San Diego, dal 7 al 10 dicembre 2024. Le presentazioni si concentreranno sul trattamento della emoglobinuria notturna parossistica (PNH), un raro disturbo del sangue.
Le presentazioni includeranno i risultati intermedi di uno studio di Fase 2 che dimostra il miglioramento dei parametri ematologici nei pazienti con PNH e uno studio di farmacocinetica/farmacodinamica. Gli studi clinici di Fase 3 per zaltenibart in PNH sono previsti per iniziare all'inizio del 2025.
Omeros (NASDAQ: OMER) ha anunciado dos presentaciones próximas sobre zaltenibart (OMS906), su inhibidor investigacional de MASP-3, que se llevarán a cabo en la 66ª Reunión Anual de la Sociedad Americana de Hematología (ASH) en San Diego, del 7 al 10 de diciembre de 2024. Las presentaciones se centran en el tratamiento de hemoglobinuria nocturna paroxística (PNH), un trastorno sanguíneo raro.
Las presentaciones incluirán resultados interinos de un estudio de prueba de concepto de Fase 2 que muestra la mejora de los parámetros hematológicos en pacientes con PNH, y un estudio de farmacocinética/farmacodinamia. Los ensayos clínicos de Fase 3 para zaltenibart en PNH están programados para comenzar a principios de 2025.
Omeros (NASDAQ: OMER)는 zaltenibart (OMS906), MASP-3 억제제에 대한 두 가지 발표를 발표했습니다. 이 발표는 미국혈액학회(ASH)의 제66회 연례 회의에서 2024년 12월 7일부터 10일까지 샌디에이고에서 열릴 예정입니다. 발표는 드문 혈액 질환인 발작성 야간 혈색소뇨증(PNH) 치료에 중점을 두고 있습니다.
발표 내용에는 PNH 환자에서 개선된 혈액학적 매개변수를 보여주는 2상 시험의 중간 결과와 약물 동태학/약리학 연구가 포함됩니다. PNH에서 zaltenibart에 대한 3상 임상 시험은 2025년 초에 시작될 예정입니다.
Omeros (NASDAQ: OMER) a annoncé deux prochaines présentations concernant zaltenibart (OMS906), leur inhibiteur expérimental de MASP-3, qui auront lieu lors de la 66ème Réunion Annuelle de la Société Américaine d'Hématologie (ASH) à San Diego, du 7 au 10 décembre 2024. Les présentations se concentreront sur le traitement de l'hémoglobinurie nocturne paroxystique (PNH), une maladie sanguine rare.
Les présentations comprendront des résultats intermédiaires d'une étude de phase 2 montrant une amélioration des paramètres hématologiques chez les patients atteints de PNH, ainsi qu'une étude de pharmacocinétique/pharmacodynamique. Des essais cliniques de phase 3 pour zaltenibart dans la PNH sont prévus pour débuter début 2025.
Omeros (NASDAQ: OMER) hat zwei bevorstehende Präsentationen zu zaltenibart (OMS906), ihrem experimentellen MASP-3-Inhibitor, angekündigt, die auf der 66. Jahrestagung der American Society of Hematology (ASH) in San Diego vom 7. bis 10. Dezember 2024 stattfinden werden. Die Präsentationen konzentrieren sich auf die Behandlung von paroxysmaler nächtlicher Hämoglobinurie (PNH), einer seltenen Bluterkrankung.
Zu den Präsentationen gehören vorläufige Ergebnisse einer Phase-2-Studie, die verbesserte hämatologische Parameter bei PNH-Patienten zeigt, sowie eine Studie zur Pharmakokinetik/Pharmakodynamik. Die klinischen Studien der Phase 3 für zaltenibart bei PNH sollen Anfang 2025 beginnen.
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-- Presentations Highlight Progress in Late-Stage Development of Lead MASP-3 Inhibitor Zaltenibart --
Both abstracts are available on the ASH website at www.hematology.org. Details of the congress presentations and direct links to the abstracts are found below.
Monotherapy Treatment with Zaltenibart (OMS906), an Alternative Pathway Masp-3 Inhibitor, Improved Key Hematologic Parameters in Patients with PNH with a Suboptimal Response to Ravulizumab: Interim Results from a Phase 2 Proof-of-Concept Study
Abstract Number / Link: 4072
Session: 508. Bone Marrow Failure: Acquired: Poster III
Presentation Time: Monday, December 9, 2024, 6:00 PM-8:00 PM
Location:
Presenting Author: Morag Griffin, MBChB, MRCP
Population Pharmacokinetics/Pharmacodynamics and Clinical Pharmacology of Zaltenibart (OMS906) in Healthy Subjects and Patients with PNH
Abstract Number / Link: 4081
Session: 508. Bone Marrow Failure: Acquired: Poster III
Presentation Time: Monday, December 9, 2024, 6:00 PM-8:00 PM
Location:
Presenting Author: William Pullman, BMedSc, MBBS, PhD, FRACP
The presentation materials associated with each abstract will be made available on Omeros’ website at www.omeros.com following the congress presentations.
About OMS906
OMS906 is an investigational human monoclonal antibody targeting mannan-binding lectin-associated serine protease-3 (MASP-3), the key and most proximal activator of the complement system’s alternative pathway. The complement system is a critical part of innate immunity and plays a central role in host homeostasis and defense against pathogens. Responsible for the conversion of pro-complement factor D to complement factor D, MASP-3 is believed to be the premier target in the alternative pathway – it has the lowest native circulating level and low relative clearance compared to the other alternative pathway proteins and, unlike C5 and C3 blockers, MASP-3 inhibition leaves intact the lytic arm of the classical pathway, important for fighting infection. Also, unlike other components of the alternative pathway, MASP-3 is believed not to be an acute phase reactant, which could provide a significant advantage to MASP-3 inhibitors, like OMS906, over other alternative pathway inhibitors. MASP-3 inhibitors are thought to have preventive or therapeutic effects across a broad range of diseases including paroxysmal nocturnal hemoglobinuria (PNH), hemolytic uremic syndrome (HUS), atypical HUS, traumatic brain injury, arthritis, geographic atrophy or “dry” macular degeneration, ischemia-reperfusion injury, transplant-related complications and other immune-related disorders.
About Omeros Corporation
Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing first-in-class small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders, including complement-mediated diseases and cancers, as well as addictive and compulsive disorders. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Omeros’ long-acting MASP-2 inhibitor OMS1029 has successfully completed Phase 1 single- and multiple-ascending dose clinical studies. OMS906, Omeros’ inhibitor of MASP-3, the key activator of the alternative pathway of complement, is advancing toward Phase 3 clinical trials for paroxysmal nocturnal hemoglobinuria and complement 3 glomerulopathy. Funded by the National Institute on Drug Abuse, Omeros’ lead phosphodiesterase 7 inhibitor OMS527 is in clinical development for the treatment of cocaine use disorder. Omeros also is advancing a broad portfolio of five novel cellular and molecular immuno-oncology programs. For more information about Omeros and its programs, visit www.omeros.com.
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Jennifer Cook Williams
Cook Williams Communications, Inc.
Investor and Media Relations
IR@omeros.com
Source: Omeros Corporation
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