The Phase II trial studied the safety, tolerability, and preliminary efficacy of PBF-677 in patients with mild to moderate Ulcerative Colitis in flair condition on top of the standard of care Mesalazine (5-ASA).
32 patients were recruited in the trial, 22 of them received PBF-677 (200mg) + 5-ASA(4g) and 10 of them received just the standard of care (4g of 5-ASA) once a day for 28 days.
The drug was safe and well tolerated in combination with standard of care treatment Mesalazine (4g 5ASA).
The trial achieved statistical significance in all the efficacy parameters measured despite the limited number of patients enrolled.
- PBF-677 treatment in combination with Mesalazine was able to reduce significantly the feacal calprotectin levels from day 14 onwards compared with basal levels at day 1
- PBF-677 treatment in combination with Mesalazine has shown statistically significant improvement in the Partial Mayo Score compared with Mesalazine alone at the end of the study.
- PBF-677 treatment in combination with Mesalazine has shown a statistically significant improvement of rectal bleeding and stool frequency compared with Mesalazine alone at the end of the study.
- PBF-677 treatment in combination with Mesalazine produce a statistically significant reduction of the C-reactive protein (CRP) levels on days 28 and at the end of study compared to basal levels at day 1.
Palobiofarma is currently evaluating different partnering/licensing opportunities for the asset.