FDA Gives Green Signal For Palisade Bio's LB1148 Phase 3 Study

Palisade Bio Inc PALI has received a "Study May Proceed" letter from the FDA for a Phase 3 trial to evaluate LB1148 to accelerate the return of bowel function in adult patients undergoing bowel/abdominal surgery.

• The trial will enroll approximately 600 subjects and assess the safety and efficacy of LB1148. 
• All patients enrolled in the trial will be undergoing a scheduled bowel resection surgery that will include either laparotomy or laparoscopic surgical approaches.
• Related: Palisade Bio's LB1148 Cuts The Risk of Adhesion Formation By 72% After Bowel Resection Surgery. 
• Palisade Bio intends to initiate the Phase 3 clinical trial in 2H of 2022.
• LB1148 is an oral formulation of a broad-spectrum serine protease inhibitor designed to neutralize the activity of potent digestive proteases released from the gut during surgery. 
• Price Action: PALI shares are up 44.7% at $1.17 during the market session on the last check Tuesday.