Clinical Trials

Clinical Trials

Our initial focus is improving patient’s quality of life following major surgery by:

  • Accelerating postoperative return of GI function
  • Preventing post-surgical adhesions
Clinical-Shield

Postoperative Return of Bowel Function

Ongoing Phase 3 Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection (INTEGRITY)

Same Dosing, Same Endpoint, Same Patients as Positive Phase 2 Study That Demonstrated 1.1 Day Improvement in Return of Bowel Function
Randomized, Double-Blind, Placebo-Controlled, Multi-Site Study, 600 patients

Evaluate LB1148 for return of GI function (GI2) in subjects undergoing elective bowel resection with a laparotomy or minimally invasive approach

Primary Endpoint: Time to return of GI function: toleration of food and 1st bowel movement (GI2)

For complete study details, please view the study listing on clinicaltrials.gov: NCT05470387

Our co-development partner, Newsoara Biopharma Co. Ltd, has received clearance from the National Medical Products Administration (NMPA) to proceed with a Phase 3 clinical trial in China.

LB1148 Demonstrated Consistent Meaningful Results in Multiple Clinical Studies
LB1148 Accelerated Return of GI Bowel Function in Completed Phase 2 GI Surgery Study

Post-Surgical Intraabdominal Adhesions

Ongoing Phase 2 Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing Bowel Resection (PROFILE)

Randomized, Double-Blind, Placebo-Controlled, Multi-Site Study
Up to 200 patients ∣ ~70 patients with a planned adhesion evaluation ∣ ～17 sites in the U.S.

Evaluate LB1148 to reduce the formation of post-surgical intra-abdominal adhesions and accelerate the return of GI function in subjects undergoing elective bowel resection with planned stoma take-down

Primary Endpoint: Extent and severity of adhesions score

For complete study details, please view the study listing on clinicaltrials.gov: NCT02836470

LB1148 Reduced Adhesion Formation in GI Surgery Patients

If you are interested in learning more about our clinical trials, please contact Palisade Bio at:
info@palisadebio.com or 858.704.4900