South Korean biopharmaceutical company Mezzion Pharma Co Ltd on Thursday announced written feedback from the US Food and Drug Administration (FDA) following a pre-IND Type C Guidance meeting interaction for the development of udenafil in autosomal dominant polycystic kidney disease (ADPKD).

Based on its review, the FDA indicated that Mezzion's nonclinical data package together with its prior clinical and safety experience with udenafil may provide a reasonable foundation to support development in clinical studies.

The company says that to date, udenafil has been studied in multiple clinical programs in other therapeutic areas with multi-year exposure. Now, Mezzion plans to add to this dataset with the goal of advancing the program toward potential Phase 2 clinical and subsequent Phase 3 development in ADPKD.

Mezzion views this pre-IND interaction as an additional step in advancing the potential development of udenafil for ADPKD and expanding potential treatment options for patients living with this progressive disease.