Tranexamic acid flops in PROFILE trial for post-surgical abdominal adhesions
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Key takeaways:
- LB1148, an oral liquid formulation of tranexamic acid, failed to reduce abdominal adhesions following elective bowel resection.
- After PROFILE trial failure, Palisade Bio has abandoned LB1148 for abdominal adhesions indication.
Topline results from the phase 2 PROFILE trial showed that Palisade Bio’s formulation of tranexamic acid failed to reduce intra-abdominal adhesions in patients following elective bowel resection, according to a company release.
With only two proposed indications for Palisade Bio’s sole drug candidate, LB1148, the failure to achieve its primary endpoint in the PROFILE trial has prompted the company to change course. Based on “safety data and efficacy results” reported in the trial, Palisade Bio has opted to abandon “further development of LB1148” for intra-abdominal adhesions.
“The PROFILE study has provided us with a definitive outcome and enabled us to quickly make the decision to no longer pursue the adhesions indication,” JD Finley, CEO of Palisade Bio, said in a press release. “Moving forward, we remain committed to the future of Palisade and are in the midst of encouraging discussions that we believe will lead to pipeline expansion opportunities in high value indications in the [gastrointestinal] space.”
Without this second indication, LB1148’s viability as a drug candidate hinges on its potential to accelerate the return of postoperative bowel function following elective bowel resection, an indication that garnered it fast track designation by the FDA in 2022.
A randomized, double-blind, placebo-controlled, proof-of-concept study, the PROFILE trial was originally intended to assess whether patients who received LB1148 experienced an expedited return of bowel function following elective bowel resection with or without a planned stoma. The trial was initiated in October 2019, but halted due to COVID-19 in July 2020, at which point only 79 patients had been enrolled.
When the trial resumed in May 2022, the original protocol was revised to also determine if patients who received LB1148 experienced a decrease in post-surgical intra-abdominal adhesions. Under the amended protocol, the trial enrolled an additional 35 of the projected 70 patients.
As of May 10, 2023, 31 patients had completed their first surgery, and only 22 patients completed the second surgery that was necessary to evaluate the primary endpoint. According to topline data, LB1148 failed to achieve the study’s primary endpoint of adhesion reduction in patients who received LB1148 (n=11) vs. those who received placebo (n=11). In addition, the company reported 30 serious adverse events from the PROFILE trial, including 16 events in the LB1148 group (with only three related to LB1148) and 14 events in the placebo group.
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