Therapy Areas: Cardiovascular
Leading BioSciences Teams with Donnelley Financial Solutions to Create Study Tool for Clinical Trial Monitoring During COVID-19 Pandemic
9 June 2020 - - US-based drug development company Leading BioSciences, Inc is working with US-based risk and compliance company Donnelley Financial Solutions (NYSE: DFIN) to manage remote monitoring of their COVID-19 study, the companies said.

LBS is taking a unique approach to investigating treatments for COVID-19 by targeting gut integrity as a potential method of disrupting viral infection and potentially reducing life-threatening complications.

The US Food and Drug Administration recently cleared LBS to conduct a phase 2 study of its lead investigational drug, LB1148, for the "treatment of pulmonary dysfunction associated with COVID-19 pneumonia."

To carry out this study, LBS faces the challenge of collecting and monitoring patient data during a global pandemic with widespread implementation of shelter-in-place orders and hospital policy revisions prohibiting non-essential visitors.

Just as COVID-19 began to impact onsite clinical study monitoring operations across the globe, LBS began working with DFIN to utilise Venue virtual data rooms as an innovative solution to virtually monitor patient data.

Use of virtual data rooms allows LBS to continue trial operations and oversight in the absence of in-person visits to hospitals and clinical sites.

LBS's use of Venue has proven to be a fast-track solution that reduces costs and has changed the way the company manages clinical trial execution.

By allowing remote monitoring and source document verification of clinical study data, LBS has been able to continue its development activities without compromising the safety of patient volunteers, or that of company and CRO team members.

Leading BioSciences is developing novel therapeutics designed to improve human health through therapeutic protection of the Gastrobiome.

The company's initial focus is combatting the interruption of GI function (ileus) following major surgery to reduce recovery times and shorten patients' length of stay in the hospital.

Additionally, the company believes that its investigational therapies have the potential to prevent the formation of post-operative adhesions (reducing hospital re-admissions and additional surgeries), as well as to address the myriad health conditions and complications associated with chronic disruption of the intestinal mucosal barrier.

LB1148 is a patent-protected formulation of a broad-spectrum serine protease inhibitor designed to neutralise the activity of potent digestive proteases that can cause a range of serious complications and organ dysfunction if they escape the GI tract through a compromised mucosal barrier.

By inhibiting the activity of digestive proteases, LB1148 has the potential to prevent damage to GI tissues, speed the return of GI function and shorten patients' post-surgery stay in the ICU and hospital.

This could substantially reduce the burden on the healthcare system based on the average cost of both ICU and hospital stays following cardiovascular surgery.

LB1148 has not been approved for use in any indication, nor has it been deemed by FDA as "safe" for use in any patient population.
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