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ImmunAbs gibt den Abschluss einer klinischen Phase-1-Studie bekannt und zeigt positive Topline-Ergebnisse
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News provided by

ImmunAbs Inc.

Mar 11, 2024, 05:23 ET

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SEOUL, Südkorea, 11. März 2024 /PRNewswire/ -- ImmunAbs, ein führendes Biotechnologieunternehmen im klinischen Stadium, das sich auf die Entwicklung neuartiger Antikörpertherapeutika konzentriert, gab heute den erfolgreichen Abschluss der klinischen Phase-1-Studie für IM-101 bekannt. IM-101 ist ein humanisierter monoklonaler Antikörper, der auf das Komplement C5 abzielt, das eine zentrale Rolle bei der Komplementaktivierung spielt. Die entscheidende Rolle des Komplementsystems bei Autoimmunkrankheiten ist allgemein bekannt.

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Die randomisierte, doppelblinde, placebokontrollierte Studie wurde durchgeführt, um die Sicherheit, Verträglichkeit und vorläufige Wirksamkeit von IM-101 zu untersuchen, einem Medikament, das auf das Komplementsystem, insbesondere das Komplement C5, abzielt. Gesunde Freiwillige erhielten eine einmalige Dosis von IM-101 oder Placebo. IM-101 erwies sich als gut verträglich, da bei keiner der getesteten Dosierungen schwere unerwünschte Ereignisse oder dosislimitierende Toxizität (DLT) beobachtet wurden. ImmunAbs freut sich zu berichten, dass die Studie alle vordefinierten Endpunkte erfolgreich erreicht hat.

Dr. Dongjo Kim, der Geschäftsführer von ImmunAbs, äußerte sich begeistert über die Ergebnisse und erklärte: „Wir freuen uns, Ihnen mitteilen zu können, dass die Topline-Ergebnisse positiv sind. In dieser Studie haben wir einen wichtigen Biomarker für die Komplementhemmung untersucht - die Konzentration von freiem C5 im Serum - und damit die Wirksamkeit von IM-101 bei der Bindung an C5 beim Menschen bestätigt. Diese Ergebnisse bilden eine solide Grundlage, um den ungedeckten medizinischen Bedarf von Patienten zu decken, die trotz der derzeitigen Standardbehandlung weiterhin Symptome haben. Wir sind sehr gespannt auf das therapeutische Potenzial von IM-101 in der bevorstehenden Phase-2-Studie."

Informationen zu ImmunAbs:

ImmunAbs ist ein 2017 gegründetes Biotechnologie-Unternehmen im klinischen Stadium. Das Unternehmen hat sich zum Ziel gesetzt, weltweit neuartige Antikörpertherapeutika zu entwickeln, wobei es sich insbesondere auf das Hauptprogramm zur Behandlung schwerer Autoimmunerkrankungen konzentriert. Unterstützt durch Eigenkapital und staatliche Zuschüsse bemüht sich ImmunAbs aktiv um weitere Investitionen und die Zusammenarbeit mit der Gesundheitsbranche, um IM-101 auf den Markt zu bringen.

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