Netherlands-based biotech company Citryll has announced the conclusion of subject dosing in the repeat dose stage of the Phase I clinical trial for its anti-inflammatory drug candidate, CIT-013.
The first-in-human Phase I study is designed to assess the safety and tolerability of the antibody.
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The part D portion of the trial will also analyse the safety and tolerability of CIT-013 through repeat dosing in a small cohort of nine subjects with rheumatoid arthritis (RA) and three healthy volunteers.
All participants have now been enrolled and successfully completed dosing, with results expected in the fourth quarter of this year.
Positive outcomes from this trial could lead to the initiation of Phase IIa trials.
CIT-013 is designed to target and control neutrophil extracellular traps (NETs), implicated in various inflammatory diseases.
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By GlobalDataNETs are released during a process called NETosis and can lead to tissue damage and prolonged inflammation if not adequately cleared by the body.
The antibody is claimed to have shown promise in controlling NETs and NETosis, which is crucial for the treatment of autoimmune and inflammatory diseases.
Citryll is initially focusing on developing CIT-013 for RA and hidradenitis suppurativa (HS), with the potential to expand its use to a broader range of immune-mediated inflammatory diseases.
The initial clinical trials for CIT-013 are expected to establish a new treatment paradigm for these conditions.
Two Phase IIa studies are planned for patients with RA and HS, which are Citryll’s lead indications for CIT-013. The successful completion of the Phase I trial dosing is a significant step toward realising the potential of this innovative therapy.
Citryll CMO Maarten Kraan said: “Reaching this important milestone in the Phase 1 study is testament to hard work across the Citryll team. We look forward to sharing data later this year and plans for Phase IIa trials are underway.
“We remain excited for the potential of CIT-013, which has demonstrated potent anti-inflammatory effects in preclinical models, positioning it as a potential game-changer in rheumatoid arthritis and hidradenitis suppurativa, as well in a wide range of inflammatory disorders.”
