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FDA clears phase 2 trial of drug candidate for ileus, adhesions
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The FDA has cleared the initiation of a phase 2 clinical trial of LB1148, a drug candidate for postoperative ileus and abdominal adhesions, the manufacturer announced.
LB1148 (Leading BioSciences) is a broad-spectrum serine protease inhibitor designed to protect the mucosal barrier of the intestine to prevent digestive enzymes from escaping, which can lead to acute shock, multiple organ failure, postoperative ileus, surgical adhesions and other conditions with limited or no treatment options, according to a press release.
The manufacturer has an open Investigational New Drug application for the drug candidate, and all of the components in its formulation are approved and have established safety profiles.
The PROFILE study is a randomized, double blind, placebo-controlled trial that will evaluate the safety, efficacy and tolerability of LB1148 for reducing adhesion formation and expediting recovery time to normal GI function when taken 8 to 10 hours before elective bowel resection in about 120 patients.
“This IND clearance is a significant milestone for Leading BioSciences, as we build momentum toward demonstrating the broad therapeutic potential of LB1148,” Greg Doyle, CEO of Leading BioSciences, said in the press release. “This study is a major pillar of our three-trial approach to demonstrate efficacy of LB1148. We are now working diligently with our partners to prepare the PROFILE trial and begin recruiting patients.”
The drug candidate is also being evaluated in a phase 2 clinical trial for post-surgical complications following cardiovascular shock, and Leading BioSciences plans to begin an investigator-sponsored study in the third quarter of the year for treating severe shock, according to the press release.
Disclosures: Doyle is employed by Leading BioSciences.