Tapping the mechanisms of digestive proteases to fight postsurgical impairment of bowel motility, plus other disorders
WHAT’S AT STAKE
This one is personal. First-person singular. Half a year ago, I experienced sepsis, an often-fatal blood infection/inflammation. Right after an outpatient surgery, I shook uncontrollably with the rigors as my temp hit 104F, and I was rushed to a hospital that fortunately diagnosed and treated me promptly. Already interested in other areas the condition touches, I spotted Leading Biosciences, a company that took sepsis as the starting point for adopting a practical route to the hoped-for approval of its first drug and indication.
The story has taken a few turns in its search to apply the scientific discoveries sepsis initially provoked. Two top scientists at the UCSD, now at Leading Biosciences, merged their separate research into how the gastrointestinal tract ends up driving diseases, particularly in situations and ways no one had foreseen. When digestive proteases, or enzymes, leak outside the GI tract, they can cause vast amounts of damage, from short-term illnesses to chronic conditions and life-threatening organ failure. Sepsis could be an overwhelming challenge for a small company like this, and Leading Biosciences has logically focused on lower-hanging fruit at first. Its lead and other candidates target needs particularly associated with surgery or hospitalization, accelerating postoperative return of delayed bowel function (ileus) and reducing intra- postoperative abdominal adhesions.
“We started down the path of developing a drug for sepsis, but we eventually realized it’s so hard to develop drugs for that commercial space,” says Thomas Hallam, CEO. “But we can develop a drug for very specific complications where it is much easier to run clinical trials. Hopefully, once we get a drug on the market, we can come back and work for sepsis.” Even the bowel indications have a distinct focus. “It’s patients who develop extensive lack of bowel function we think we can help the most. But we could help everyone, at least a little.” Cost reduction could be part of the solution. Postsurgical adhesion care runs up to $1 billion per year in the United States just in patient returns, he says.
A Phase 2 clinical study of the lead drug in heart-surgery patients achieved its primary endpoint at the end of analysis. On a heart-bypass pump, blood flows to the brain, lungs, and heart to keep those organs alive, but there’s very low blood-profusion of the gastrointestinal tract, which delays return of bowel function. “In that study, we administered our drug at time of surgery, and we demonstrated an 18-hour improvement return of bowel function in those patients,” says Hallam. The company hopes to complete a single Phase 3 study and gain first market approval in only three years, thanks partly to extensive historical research on its drug.
As a research-based company, Leading Biosciences still has its eye firmly on the target market — anchored in surgery and the hospital. “In this industry, you can’t ever really separate the business from the science,” says Hallam. “The best companies love their science, know their science, and also know that even if you have great science but it has no commercial potential, pursuing it makes no sense.” His company already aims to offer improved quality outcomes and DRG-related pricing to hospitals to help their bottom lines. Combined with clinical success, the early thinking could be its best grip on the future.
Headquarters: Carlsbad, CA
$32M total raised to date
Research Partnership Funding
NIH — $22 million in grants
Newsoara Biopharma Co., Ltd. - Exclusive development and commercialization rights for LB1148 in China in exchange for milestone payments and royalties on sales
October 2018: Expanded board of directors
June 2018: Announced positive interim results from Phase 2 study in major cardiovascular surgery patients
2018: Signed licensing deal with Newsoara Biopharma Co., Ltd. For LB1148 in China