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Palisade Bio and Newsoara Receive NMPA Clearance to Commence Phase 3 Clinical Trial in China Evaluating LB1148 to Accelerate the Return of Bowel Function Following Abdominal Surgery
NMPA clearance expands global Phase 3 clinical development program; Company recently announced clearance from U.S. Food and Drug Administration to commence
About this update from Palisade Bio, Inc.
[{"type":"text","content":"NMPA clearance expands global Phase 3 clinical development program; Company recently announced clearance from U.S. Food and Drug Administration to commence Phase 3 study Newsoara to fully fund Phase 3 program in China Under the Co-Development Agreement, commencement of Phase 3 program in China will trigger milestone payment to Palisade Bio CARLSBAD, Calif. and SHANGHAI, China, May 05, 2022 (GLOBE NEWSWIRE) -- Palisade Bio (Nasdaq: PALI), a clinical stage biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications and co-development partner Newsoara Biopharma Co. Ltd, today announced they have received clearance from the National Medical Products Administration (NMPA) in China to proceed with their Phase 3 clinical trial to evaluate LB1148 for accelerated return of bowel function in adult patients undergoing bowel/abdominal surgery. This comes shortly after the announcement of the Phase 3 protocol clearance by the U.S. Food and Drug Administration (FDA). 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. In a previously conducted Phase 2 trial in gastrointestinal (GI) surgery, Palisade Bio and Newsoara demonstrated LB1148 had a statistically significant (p=0.0008) effect in accelerating the return of bowel function in patients undergoing elective bowel resection surgery. Based on the strong efficacy profile in acceleration of the time to recover bowel function combined with a favorable safety and tolerability profile observed, Palisade Bio and Newsoara are advancing LB1148 to Phase 3 clinical trials in the United States and China for accelerating the return of bowel function for major surgical indications. The Phase 3 trial is designed as a multi-centered, randomized, double-blinded, parallel-group, placebo-controlled clinical trial, and will assess the safety and efficacy of LB1148. All patients enrolled in the trial will undergo a scheduled bowel resection surgery that will include either laparotomy or laparoscopic surgical approaches. “The clearance from NMPA for the expansion of the LB1148 Phase 3 program in China represents an important milestone for our global development and commercial strategies for LB1148. As demonstrated in the successful Phase 2 stu...