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.
Palobiofarma is currently evaluating different partnering/licensing opportunities for the asset.
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