BRG’s Contribution to the Advancement of an Innovative Therapy

Phase I clinical trials conducted at BRG play a key role in the development of new therapies. One example is the CPL’116 molecule, developed by Celon Pharma S.A., whose initial stages were carried out at our site as early as 2018, with the support of European funds under the Smart Growth Operational Programme (POIR), via the National Centre for Research and Development (NCBR), Poland.

In the First-in-Human (FIH) study, including single and multiple ascending dose cohorts (SAD, MAD), the safety and pharmacokinetics of the molecule were evaluated in healthy volunteers. The results enabled the selection of appropriate doses for further stages of clinical development. The results of the Phase I study were published in 2025:
https://doi.org/10.3389/fphar.2025.1583723

The next step was the continuation of the project in a Phase II study conducted in patients with rheumatoid arthritis (RA), the results of which were recently published in a scientific journal:
https://doi.org/10.1016/s2665-9913(25)00060-8

The data generated at our site formed the foundation for the further development of this therapy and enabled its progression to subsequent stages of clinical trials.

This example demonstrates that BRG is not only a site for conducting early-phase studies, but above all a starting point for the development of innovative therapies that have a real potential to advance through clinical development and ultimately reach patients.

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