Express Pharma

JJP Biologics to execute in-human clinical trial of Anti-Inflammatory mAb JJP-1212 (anti-CD89)

JJP Biologics has received a positive conclusion on the Clinical Trial Application assessment for a Phase I Study of a potential first-in-class anti-CD89 antagonist, JJP-1212 monoclonal antibody for the treatment of various IgA-mediated autoimmune- and fibrotic diseases

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JJP Biologics, a private biopharmaceutical company developing innovative antibody-based therapies, announces a positive decision, issued by the European Medicines Agency, on the Clinical Trial Application to conduct a phase I clinical study in healthy participants (EudraCT: 2023-508661-33-00) with their anti-CD89 antagonist, JJP-1212.

The Phase I trial will be executed in Poland. The study endpoints are designed for a comprehensive evaluation of the treatment’s safety profile. The drug will be administered via intravenous infusion in single and multiple ascending dose cohorts. Population size was determined as 48 healthy adult volunteers. 

The study results will provide data on the safety and tolerability of JJP-1212, and full PK/PD profiles that subsequently enable the determination of optimal treatment regimens in future studies with patient populations. JJP Biologics intends to use Phase I read-outs as supporting data for a set of Phase II trials, in a range of therapeutic areas, and regions (including EU and the US).

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