Omeros Corporation Announces Presentation of Positive Zaltenibart Data at ASH Annual Meeting
Omeros (OMER) presented two posters about zaltenibart (OMS906), their investigational MASP-3 inhibitor, at the ASH Annual Meeting. The presentations focused on Phase 2 clinical data and clinical pharmacology analyses for treating paroxysmal nocturnal hemoglobinuria (PNH).
The Phase 2 'switch-over' study showed that zaltenibart monotherapy achieved sustained improvements in hemoglobin and absolute reticulocyte count in PNH patients who had inadequate response to ravulizumab. The treatment was well-tolerated with no concerning safety signals.
Pharmacokinetic/pharmacodynamic modeling identified 8mg/kg as the optimal intravenous dose administered every 8 weeks, achieving >98% suppression of alternative pathway activation. Phase 3 clinical trials are expected to begin enrollment in early 2025.
Omeros (OMER) ha presentato due poster riguardanti zaltenibart (OMS906), il loro inibitore sperimentale di MASP-3, durante l'Incontro Annuale ASH. Le presentazioni si sono concentrate su dati clinici di Fase 2 e analisi di farmacologia clinica per il trattamento dell'emoglobinuria notturna parossistica (PNH).
Lo studio 'switch-over' di Fase 2 ha dimostrato che la monoterapia con zaltenibart ha raggiunto miglioramenti sostenuti nell'emoglobina e nel conteggio assoluto dei reticolociti nei pazienti con PNH che avevano risposto in modo inadeguato al ravulizumab. Il trattamento è stato ben tollerato, senza segnali di sicurezza preoccupanti.
La modellizzazione farmacocinetica/farmacodinamica ha identificato 8mg/kg come la dose ottimale intravenosa somministrata ogni 8 settimane, raggiungendo una soppressione >98% dell'attivazione della via alternativa. Si prevede che i trial clinici di Fase 3 inizino ad accettare iscrizioni all'inizio del 2025.
Omeros (OMER) presentó dos carteles sobre zaltenibart (OMS906), su inhibidor experimental de MASP-3, en la Reunión Anual de ASH. Las presentaciones se centraron en datos clínicos de Fase 2 y análisis de farmacología clínica para el tratamiento de la hemoglobinuria nocturna paroxística (PNH).
El estudio 'switch-over' de Fase 2 mostró que la monoterapia con zaltenibart logró mejoras sostenidas en la hemoglobina y en el conteo absoluto de reticulocitos en pacientes con PNH que tuvieron una respuesta inadecuada a ravulizumab. El tratamiento fue bien tolerado, sin señales de seguridad preocupantes.
El modelado farmacocinético/farmacodinámico identificó 8mg/kg como la dosis intravenosa óptima administrada cada 8 semanas, logrando una supresión >98% de la activación de la vía alternativa. Se espera que los ensayos clínicos de Fase 3 comiencen a inscribirse a principios de 2025.
Omeros (OMER)는 ASH 연례 회의에서 그들의 실험적 MASP-3 억제제 zaltenibart (OMS906)에 대한 두 개의 포스터를 발표했습니다. 발표는 2상 임상 데이터 및 발작성 야간 혈색소뇨(PNH) 치료를 위한 임상 약리학 분석에 중점을 두었습니다.
2상 '교차 전환' 연구에서는 zaltenibart 단독 요법이 ravulizumab에 대한 반응이 불충분한 PNH 환자들에서 혈색소와 절대 망상적 혈구 수치의 지속적인 개선을 달성했음을 보여주었습니다. 이 치료는 안전성 신호가 걱정되지 않을 정도로 잘 견디는 것으로 평가되었습니다.
약리학적 반응 모델링 결과 8mg/kg이 8주마다 투여되는 최적의 정맥 주사 용량으로 확인되어 대체 경로 활성화의 >98% 억제를 달성했습니다. 3상 임상 시험은 2025년 초에 시작될 예정입니다.
Omeros (OMER) a présenté deux affiches sur zaltenibart (OMS906), leur inhibiteur expérimental de MASP-3, lors de la Réunion Annuelle ASH. Les présentations se sont concentrées sur les données cliniques de Phase 2 et les analyses de pharmacologie clinique pour le traitement de l'hémoglobinurie nocturne paroxystique (PNH).
L'étude de 'switch-over' de Phase 2 a montré que la monothérapie avec zaltenibart a permis d'obtenir des améliorations soutenues de l'hémoglobine et du compte absolu de réticulocytes chez des patients atteints de PNH ayant présenté une réponse inadéquate au ravulizumab. Le traitement a été bien toléré, sans signaux de sécurité préoccupants.
La modélisation pharmacocinétique/pharmacodynamique a identifié 8mg/kg comme la dose intraveineuse optimale administrée toutes les 8 semaines, atteignant >98% de suppression de l'activation de la voie alternative. Les essais cliniques de Phase 3 devraient commencer à recruter des participants au début de 2025.
Omeros (OMER) hat auf dem ASH-Jahrestreffen zwei Poster über den experimentellen MASP-3-Hemmer zaltenibart (OMS906) präsentiert. Die Präsentationen konzentrierten sich auf daten aus klinischen Studien der Phase 2 und klinisch-pharmakologische Analysen zur Behandlung der paroxysmalen nächtlichen Hämoglobinurie (PNH).
Die 'Switch-over'-Studie der Phase 2 zeigte, dass die Monotherapie mit zaltenibart nachhaltige Verbesserungen des Hämoglobin- und des absoluten Retikulozytenwerts bei PNH-Patienten erreichte, die unzureichend auf Ravulizumab reagiert hatten. Die Behandlung war gut verträglich und es gab keine besorgniserregenden Sicherheitssignale.
Pharmakokinetische/ -dynamische Modellierung identifizierte 8mg/kg als die optimale intravenöse Dosis, die alle 8 Wochen verabreicht wird und eine >98%ige Unterdrückung der Aktivierung des alternativen Weges erreicht. Die klinischen Studien der Phase 3 werden voraussichtlich Anfang 2025 mit der Rekrutierung beginnen.
- Phase 2 clinical trial demonstrated positive efficacy results with improvements in key hematologic parameters
- Treatment was well-tolerated with favorable safety profile
- Successful identification of optimal dosing regimen for Phase 3 trials
- Clear pathway to Phase 3 trials with enrollment planned for early 2025
- None.
Insights
The positive Phase 2 data for zaltenibart in PNH represents a significant development. The drug demonstrated meaningful clinical improvements in both hemoglobin levels and reticulocyte counts while preventing both types of hemolysis in patients who had inadequate responses to current standard therapy. This is particularly noteworthy as it addresses an unmet medical need for PNH patients who don't respond well to C5 inhibitors.
The pharmacokinetic/pharmacodynamic data supporting the 8mg/kg dosing regimen every 8 weeks is compelling, showing
This clinical milestone strengthens Omeros' position in the lucrative rare disease market. The PNH therapeutics market is projected to grow significantly, currently dominated by AstraZeneca's Soliris/Ultomiris. With a market cap of
The demonstrated efficacy in patients who had suboptimal responses to existing treatments suggests potential for market penetration upon approval. The convenient 8-week dosing schedule could provide a competitive edge in patient compliance and market adoption. However, investors should note that Phase 3 trials won't begin until early 2025, indicating a considerable timeline before potential commercialization.
-- Clinical Trial and Clinical Pharmacology Data Support Upcoming Enrollment of Omeros’ Zaltenibart Phase 3 Clinical Program in PNH --
Morag Griffin, MBChB, FRCPath, Consultant in Haematology of St. James University Teaching Hospital,
The second poster details pharmacokinetic/pharmacodynamic (PK/PD) modeling of multiple zaltenibart doses, resulting in identification of a minimal threshold concentration of sufficient effectiveness. These PK/PD data support the selection of 8mg/kg as the optimal dose for intravenous administration every 8 weeks to achieve complete suppression (> 98 percent) of alternative pathway activation – the dosing regimen that will be used in the Phase 3 PNH clinical trials.
The full poster presentations are available on the Omeros website at https://investor.omeros.com/presentations. Both abstracts are available on the ASH website at www.hematology.org.
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
Population Pharmacokinetics/Pharmacodynamics and Clinical Pharmacology of Zaltenibart (OMS906) in Healthy Subjects and Patients with PNH
Abstract Number / Link: 4081
About Zaltenibart (OMS906)
Zaltenibart (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 zaltenibart, 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. Zaltenibart, 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241210351040/en/
Jennifer Cook Williams
Cook Williams Communications, Inc.
Investor and Media Relations
IR@omeros.com
Source: Omeros Corporation
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