This trial was originally designed to evaluate whether patients treated with LB1148 would accelerate the return of GI function in subjects undergoing elective bowel resection with or without a planned stoma. 

The study commenced in October 2019 and was paused in July 2020 due to COVID-19. During that timeframe, 79 patients were enrolled. 

The study was restarted in May 2022, where the protocol was amended to evaluate whether patients treated with LB1148 would experience a reduction in the formation of post-surgical intra-abdominal adhesions in subjects undergoing elective bowel resection with planned stoma take-down. 

The study enrolled an additional 35 of the planned 70 patients under this amended protocol.

Topline data demonstrated that LB1148 did not achieve the primary endpoint of reducing adhesions in LB1148-treated patients (n=11) compared to placebo-treated patients (n=11) post-bowel resection surgery.

There were 30 serious adverse events (SAEs), with 16 SAEs reported in the LB1148 group (3 related to LB1148) versus 14 in the placebo group.

The company does not believe the safety data and efficacy results of the Phase 2 PROFILE trial support further development of LB1148 for a reduction in intra-abdominal adhesions.

Price Action: PALI shares are down 67.7% at $0.64 during the premarket session on the last check Wednesday.