Rigel Pharmaceuticals, Inc. a yau ya sanar da buga bayanai a cikin American Journal of Hematology daga buɗaɗɗen lakabin, multicenter, Phase 2 nazarin asibiti na fostamatinib a cikin manya tare da dumi antibody autoimmune hemolytic anemia (wAIHA) wanda ya kasa a kalla daya kafin magani. Bayanan da aka buga sun nuna cewa fostamatinib, mai hana tyrosine kinase (SYK) na baka, yana haɓaka matakan haemoglobin cikin sauri da ɗorewa, tare da ma'anar Hgb mai ma'ana a asibiti da aka lura a kusan rabin marasa lafiya, da bayanin martaba da aminci da haƙuri daidai da abubuwan da ake dasu. fostamatinib aminci database na marasa lafiya a fadin cututtuka da yawa da aka yi nazari. Littafin, mai suna "Fostamatinib don maganin anemia mai ɗumi autoimmune hemolytic anemia: Phase 2, multicenter, open-label study", yana samuwa akan gidan yanar gizon mujallu.
"Sakamakon da aka gani a cikin bincikenmu na Phase 2 a cikin anemia mai zafi na autoimmune hemolytic anemia yana ƙarfafa yuwuwar fostamatinib don taimakawa marasa lafiya tare da wannan cuta mai wuyar gaske, wanda ba a yarda da maganin cutar da aka yi niyya ba a halin yanzu," in ji Raul Rodriguez, shugaban Rigel kuma babban jami'in gudanarwa. jami'in. "Idan an amince, fostamatinib yana da yuwuwar zama farkon-zuwa-kasuwa magani ga marasa lafiya tare da wAIHA a cikin 2023 kuma zai zama nuni na biyu da aka amince da fostamatinib."
Nazarin Phase 2 ya kimanta martani ga fostamatinib a 150 mg BID (sau biyu a rana) a cikin manya marasa lafiya tare da wAIHA da hemolysis mai aiki tare da Hgb na ƙasa da 10 g/dL wanda ya gaza aƙalla magani ɗaya kafin. Maƙasudin ƙarshen farko shine Hgb mafi girma fiye da 10 g/dL tare da haɓaka ≥2 g/dL daga tushe ta mako na 24 ba tare da maganin ceto ba ko ƙarin jini na jan jini. Binciken ya nuna cewa 46% (11 / 24) na marasa lafiya sun cimma matsayi na farko, tare da 1 marigayi mai amsawa a mako 30 (jimlar 12 masu amsawa [50%)]. An gano haɓakar matsakaicin Hgb a Makon 2 kuma an ci gaba da kasancewa a kan lokaci. Mafi yawan abubuwan da ba su da kyau (AEs) sune gudawa (42%), gajiya (42%), hauhawar jini (27%), dizziness (27%), da rashin barci (23%). AEs sun kasance masu iya sarrafawa kuma sun yi daidai da bayanan aminci na fostamatinib na sama da marasa lafiya 3,900 a fadin cututtuka da yawa (rheumatoid arthritis, lymphoma B-cell, COVID-19, da thrombocytopenia na rigakafi (ITP)). Ba a sami sabon siginar tsaro ba.
ABUBUWAN DA ZA KU GUDU DAGA WANNAN LABARI:
- today announced the publication of data in the American Journal of Hematology from the open label, multicenter, Phase 2 clinical study of fostamatinib in adults with warm antibody autoimmune hemolytic anemia (wAIHA) who had failed at least one prior treatment.
- The published data demonstrate that fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, rapidly and durably increased hemoglobin (Hgb) levels, with clinically meaningful Hgb responses observed in nearly half of the patients, and a safety and tolerability profile consistent with the existing fostamatinib safety database of patients across multiple disease programs studied.
- The Phase 2 study evaluated the response to fostamatinib at 150 mg BID (twice daily) in adult patients with wAIHA and active hemolysis with Hgb of less than 10 g/dL who had failed at least one prior treatment.
