JJP-1212 / JJP Biologics - LARVOL DELTA

JJP-1212-01-01: A clinical study to assess if a new investigational medicinal product called JJP-1212 is safe, tolerable and able to induce a specific immune response in humans (clinicaltrialsregister.eu) - P1 | N=76 | Recruiting | Sponsor: Jjp Biologics Sp. z o.o.

New P1 trial • Dermatology • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

JJP Biologics Announces Positive Top-Line Phase I Trial Results of JJP-1212, its anti-CD89 antagonist (GlobeNewswire) - "All primary endpoints of the trial were met. Unblinded statistical analysis demonstrated a favorable outcome with regards to the safety and tolerability profile of JJP-1212: No dose-limiting toxicities were observed across the dose levels tested. Adverse events were reported to be mild-to-moderate. Laboratory safety parameters demonstrated no clinically significant abnormalities. Favorable PK profile with a typical monoclonal antibody half-life of approximately three weeks....'We look forward to reporting the next set of results from our Phase 1b trial in Linear IgA Disease in Q1 2026 and initiating a broad clinical program of Phase 2 trials by Q3 2026'."

New P2 trial • P1 data • Immunology

JJP Biologics Announces Positive Decision to Execute a First-in-Human Clinical Trial of Anti-Inflammatory mAb JJP-1212 (anti-CD89) (Businesswire) - "JJP Biologics...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 potential first-in-class anti-CD89 antagonist, JJP-1212....The Phase I trial will be executed in Poland....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."

New P1 trial • Immunology

Anti-CD89 antibody for personalized treatment of IgA-mediated inflammatory disorders: Autoantigen-specific IgA, a biomarker with strong effector functions (FOB-USA 2024) - "JJP-1212 is a potential first-in-class IgG4 CD89 antagonist that inhibits binding and subsequent activation of CD89-positive myeloid cells by IgA. Additionally, JJP Biologics is developing serum-IgA-based companion diagnostics to stratify patients to provide them with a truly personalized treatment."

Biomarker • Immunology • Inflammation