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Leading BioSciences, Inc. ("LBS" or "the Company"), a privately held company that recently entered into a definitive agreement for a reverse merger with Seneca Biopharma, Inc. (NASDAQ:SNCA), subject to certain conditions to be completed, to form Palisade Bio, Inc., announced data from an open label GI surgery study with lead asset LB1148 that provided an early indication of efficacy signal in reducing post-surgical adhesions following elective bowel resection. No abdominal adhesions were observed at the time of a follow-up surgery in two patients treated with LB1148.
Although these are early data in a limited number of patients, the data may support the Company's ongoing Phase 2 clinical trial to evaluate the impact of LB1148 on return to bowel function, length of stay, and postoperative intra-abdominal adhesions.
"Even with good surgical technique intra-abdominal adhesions can be found in more than 90% of patients after intra-abdominal surgery," said Dr. Michael Dawson, Chief Medical Officer of Leading BioSciences. "Adhesion-related complications such as small bowel obstructions, pain and infertility occur in up to 19% of abdominal surgery patients. These early data may indicate that LB1148 is reducing the formation of adhesions. We look forward to testing this hypothesis formally in our later stage clinical studies."
Previously the company described statistically significant data from the Phase 1, single-site, open-label, investigator-sponsored trial, called LBS-IST-POI-101, that enrolled 11 and evaluated 10 patients at a hospital in the United States. The trial evaluated the use of LB1148 for safety and preliminary efficacy in subjects undergoing elective bowel resection. LB1148 treated patients had a statistically significant reduction in hospital length of stay by 1.3-days when compared with expected length of stay based on their billing code at admission.
Previous studies in similar patients have demonstrated adhesions are found in more than 90% of patients after intra-abdominal surgery. Adhesion-related complications such as small bowel obstructions, pain and infertility occur in up to 19% of abdominal surgery patients.
In the LBS-IST-POI-101 study, three of the 11 patients enrolled underwent follow-up surgical procedures. For two of these patients, the patient had no intra-abdominal adhesions at the time of the follow-up surgery. A third patient's follow-up surgery was conducted on an emergent basis 14 days postoperatively by a surgeon who was not participating as an investigator in the clinical trial, and so the extent and severity of adhesions were not formally assessed. Although an official evaluation of adhesions was not provided, the surgical notes do not describe any adhesions during the surgery.
Generally, treatment with LB1148 was well tolerated. AEs were not considered unexpected in this patient population. None of the AEs or SAEs reported were considered drug-related by the sponsor-investigator.
Tom Hallam, Ph.D., Chief Executive Officer of Leading BioSciences added, "To our knowledge, there are currently no oral therapies available to reduce post-surgical intraabdominal adhesions in patients undergoing abdominal and pelvic surgery. If this efficacy signal continues to be observed in later stage studies, LB11148 may be a beneficial treatment for post-surgical adhesions for patients under these surgeries. Further, we are exploring changes to the trial design that would facilitate reading out the adhesions data earlier."
The above-mentioned results were previously disclosed in the company's December 17, 2020 conference call. Full results for the open-label GI study are expected to be disclosed at an upcoming conference in 2021.
Posted In: SNCA
