Netherlands-based biotech company Citryll has announced the successful completion of patient dosing in the repeat dose stage of its Phase I clinical trial for CIT-013, a novel anti-inflammatory drug candidate targeting neutrophil extracellular traps (NETs). The milestone marks a significant step forward for what could become a first-in-class therapeutic approach to treating immune-mediated inflammatory diseases.
Phase I Trial Design and Completion
The first-in-human Phase I study is designed to assess the safety and tolerability of CIT-013. Part D of the trial investigated the safety and tolerability of repeat dosing in 9 patient volunteers with rheumatoid arthritis (RA) and 3 healthy volunteers. All trial participants have been enrolled and successfully completed dosing, with results anticipated in Q4 2024.
If positive, these results would lay the groundwork for the initiation of Phase IIa trials. Two Phase IIa studies are planned in patients with RA and hidradenitis suppurativa (HS), which represent Citryll's lead indications for CIT-013.
Novel Mechanism Targeting NETs
CIT-013 offers a novel therapeutic approach for treating inflammatory diseases by targeting neutrophil extracellular traps (NETs), which play a significant role in the body's inflammatory processes. NETs are released during a process called NETosis and can contribute to tissue damage and sustained inflammation when not properly cleared by the body.
The drug candidate features a dual mode of action that inhibits NET formation and promotes the clearance of existing NETs by specifically targeting citrullinated histones, a hallmark of NETs. This precise targeting mechanism positions CIT-013 as a potentially transformative approach to controlling inflammation at its source.
Clinical Development Strategy
Citryll is initially developing CIT-013 for rheumatoid arthritis and hidradenitis suppurativa, which may serve as enabling indications for a broader spectrum of autoimmune and inflammatory diseases. The company believes these initial clinical trials with CIT-013 are expected to provide the foundation for a new treatment paradigm for immune-mediated inflammatory diseases.
"Reaching this important milestone in the Phase 1 study is testament to hard work across the Citryll team," said Maarten Kraan, M.D., Ph.D., CMO at Citryll. "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."
Company Background and Vision
Citryll has translated a deep understanding of the neutrophil extracellular trap (NET) pathway to therapeutically address its central role in a broad range of immune-mediated inflammatory diseases. With its unique dual mode of action, the company's lead antibody CIT-013 has reached the clinic by demonstrating a precise and powerful ability to control NETs and NETosis.
The successful completion of the Phase I trial dosing represents a significant step toward realizing the potential of this innovative therapy and establishing a new treatment paradigm for autoimmune and inflammatory conditions.
