Improve postoperative gastrointestinal function LBS drug candidate LB1148 harvest positive 2 interim results

Improve postoperative gastrointestinal function LBS drug candidate LB1148 harvest positive 2 interim results

June 21, 2018 Source: Sina Pharmaceutical

On June 19, Leading BioSciences, a drug development company dedicated to improving human health through the therapeutic protection of GastrobiomeTM, reported mid-term positive data on its clinical trial of a major drug candidate, LB1148, in patients undergoing cardiovascular surgery. Interim analysis showed that patients who received LB1148 had a 1.1-day reduction in hospital stay in the intensive care unit (ICU) compared with placebo, and a total reduction in hospital stay of 3.2 days.

Other studies showed that patients with LB1148 showed a statistically significant 18-hour improvement in recovery of normal bowel function compared with placebo (p=0.044), which was also the primary endpoint of the study. Compared with the current treatments that have been approved to improve postoperative gastrointestinal (GI) function recovery, approved therapies have been less effective in improving intestinal function recovery after GI surgery. The results of the interim study also showed that the adverse events of LB1148 were comparable to those of placebo and were well tolerated.

Tom Hallam, CEO of Leading BioSciences, said: "LB1148 has a statistically significant improvement in restoring normal gastrointestinal function. This potential can not only improve the patient's overall surgical experience, but also shorten the patient's ICU and hospital. Hospitalization time and associated costs. Importantly, these data from LB1148 showed faster recovery of GI function, as well as significant drug delivery and safety, compared to the only treatment currently approved in the United States to improve postoperative bowel function recovery. Benefits. We believe these results support the potential of LB1148 to address a critical unmet medical need while providing significant cost savings for patients, hospitals and healthcare systems."

David B. Hoyt, a professor of surgery at the University of California, said: "As a surgeon, I have personally experienced the limitations of current treatment options for postoperative GI function recovery. I am encouraged by the interim data reported by LB1148 because it shows this treatment. Ultimately, it may bring significant benefits to patients and hospitals. I will focus on the continued development of treatment and look forward to reporting all the data for this study later this year."

There are more than 10 million surgeries per year in the United States, which can lead to the destruction of the natural intestinal mucosal barrier and trigger postoperative GI function disorders. Importantly, patients undergoing these procedures are generally unable to leave the hospital until their GI function is restored, which can increase their length of hospital stay by a few days. It is estimated that waiting for the recovery of GI function every other day will result in a hospitalization cost of approximately $3,500. Therefore, a treatment that can safely and effectively reduce the delay in recovery of gastrointestinal function after surgery has the potential to save a lot of money for hospitals, insurance companies, and medical systems.

LB1148 is a patented formulation of broad-spectrum serine protease inhibitors designed to neutralize the activity of potent digestive enzymes that cause a series of serious complications if they escape the intestinal tract through a damaged mucosal barrier. Safe and effective inhibition of digestive protease activity can prevent damage caused by escape from the intestine, accelerate the recovery of intestinal function, and shorten the residence time of patients in the ICU and hospital after surgery.

The current Phase 2 clinical study of LB1148 is a randomized, double-blind, parallel, placebo-controlled trial involving a total of 120 patients undergoing coronary artery bypass grafting (CABG) and/or requiring cardiopulmonary bypass (CPB) heart valve replacement surgery. The patient underwent a study. Patients were randomized to either LB1148 or placebo and were treated with surgery. The primary objective of this trial was to evaluate the improvement in LB1148 compared to placebo for postoperative recovery. The results were measured by assessing the effect of treatment on the time to return to normal GI function, hospital stay in ICU, hospital stay, and mortality. Leading BioSciences will announce the results of the mid-term trial at a future medical conference. (Sina Pharmaceutical Compilation / David)

Article Reference Source: Leading BioSciences Reports Positive Interim Results from Phase 2 Trial of LB1148 in Patients Undergoing Major Surgery

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