Palisade Bio Receives the US FDA’s Study May Proceed Letter for P-III Clinical Trial of LB1148 to Improved Bowel Function After Abdominal Surgery
Shots:
- The US FDA has issued a study may proceed letter for the P-III trial to evaluate LB1148 vs PBO in 600 patients to accelerate the return of bowel function who undergoes bowel/abdominal surgery. The trial is expected to be initiate in H2’22
- In the 2 P-II trials results for cardiovascular & GI surgery patients, the therapy showed a significant acceleration of return of GI function & has the potential to prevent damage to GI tissues & shorten the duration of costly post-surgery hospital stays
- LB1148 is an oral formulation of a broad-spectrum serine protease inhibitor & is designed to neutralize the activity of potent digestive proteases released from the gut during surgery
Ref: Globe Newswire | Image: Palisade
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