Palisade Bio has initiated enrolment and dosing of patients in its dose optimisation clinical trial of LB1148, a broad-spectrum serine protease inhibitor.
The company’s lead programme, LB1148, neutralises digestive enzymes thereby reducing damage to the intestine.
The study is designed to determine if a different dosing protocol for all indications might improve LB1148’s risk profile while providing efficacy at the same time.
It intends to enrol over 32 healthy subjects.
LB1148’s previous clinical studies have showed positive results in reducing the severity of post-surgical abdominal adhesions.
They also demonstrated that treatment with LB1148 potentially reduced the time to return of postoperative bowel function.
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Palisade Bio interim CEO J.D. Finley said: “The dose optimisation study is designed to generate valuable pharmacokinetic and pharmacodynamic data across multiple doses in healthy adult volunteers.
“We believe the outcome of this study will add to our growing body of data and provide the line of sight needed to further guide our LB1148 clinical development strategy moving forward.”
The company intends to complete patient enrolment in LB1148’strial in the third quarter of this year.
The company’s Phase II study currently underway is evaluating LB1148’s effectiveness in reducing intra-abdominal adhesions, and accelerating return of gastrointestinal function.
The study is also demonstrating LB1148’s effectiveness in the prevention of post-operative ileus in subjects who are undergoing elective bowel resection.