Newsoara Biopharma has enrolled the first patient in its Phase lll trial of LB1148 to speed up the return of bowel function after abdominal surgery.
The multi-centered, randomised, double-blinded, parallel-group, placebo-controlled trial is being conducted in China.
It has been designed to evaluate the safety and efficacy of LB1148 in the targeted patients.
Patients participating in the trial will go through a scheduled bowel resection surgery that will be carried out through laparotomy or laparoscopic surgical methods.
Newsoara CEO Dr Benny Li said: “We believe LB1148 has continued to demonstrate the potential to address the delayed return of bowel function, which impacts millions of patients across the globe every year.
“With the first patient now enrolled in the Phase lll study, our team is focused on continuing execution of our development plans to advance toward successful completion of the study and data readout.
“We look forward to potentially bringing LB1148 to patients to improve post-operative outcomes by accelerating postoperative return of GI function and reducing post-surgical adhesions.”
Previously, Newsoara reached a deal with Palisade Bio to conduct and fund the development of LB1148 in China, including the Phase lll trial.
Newsoara will also make milestone payments to Palisade Bio after achieving certain clinical, regulatory and, if approved, commercial milestones as well as tiered royalty payments on future annual net sales of LB1148 in greater China, as part of the deal.
LB1148, Palisade’s lead candidate, is a broad-spectrum serine protease inhibitor that is capable of neutralising digestive enzymes, thereby potentially minimising intestinal damage.