FDA Grants Fast Track Status for LB1148

A new treatment for the accelerated return of bowel function after gastrointestinal surgery has been granted Fast Track Designation by the US Food and Drug Administration (FDA).

The treatment, LB1148, is a broad-spectrum serine protease inhibitor that acts to neutralize digestive enzymes, can possibly reduce abdominal adhesions and accelerate the return of bowel function following gastrointestinal surgery. The treatment is developed by Palisade Bio and is considered a novel oral liquid formulation of the digestive enzyme inhibitor tranexamic acid.

“Receiving Fast Track designation represents an important regulatory milestone for the Company. Although our current focus is on our adhesions study, this designation provides what we believe is a key component to our future clinical and regulatory strategies as we continue to formulate next steps for studying the return of bowel function,” JD Finley, interim CEO of Palisade Bio, said in a statement.

The company began enrolling patients in the phase 3 study in August.

“The dosing of our first patient in the LB1148 Phase 3 marks a noteworthy milestone for the company and another important step forward in the execution of our strategy. With what we believe to be a pivotal Phase 3 study now fully underway, we are focused on building momentum and completing enrollment as quickly and efficiently as possible,” Tom Hallam, PhD, Chief Executive Officer of Palisade Bio, said in a statement. “The design of this Phase 3 study mirrors that of our positive Phase 2 study where LB1148 demonstrated a statistically significant improvement in the time of return of bowel function.”

The phase 3, multi-center, randomized, double-blind, parallel-group, placebo-controlled clinical trial will assess the safety and efficacy of the treatment, with a primary endpoint of the time to recovery of the upper and lower gastrointestinal tract following surgery, defined as the time from the end of surgery to the toleration of food and first bowel movement.

Each participant will undergo a scheduled bowel resection surgery that will include either laparotomy or minimally invasive surgical approaches.