Fighting C difficile Before It Starts: Lopoxy Therapeutics Approach
CEO Larry Sutton, MD, PhD, discusses SIDIPREV, a novel oxygen-based therapy aimed at preventing C difficile infections.
LPOXY Therapeutics, Inc has acquired assets from Xeno Biosciences Inc. to advance its therapy SIDIPREV for preventing Clostridioides difficile (C difficile) infections in hospitalized patients. The acquisition includes regulatory filings, FDA correspondence, CMC data, intellectual property, and data from Phase I and Ib clinical trials showing the safety of the active pharmaceutical ingredient. This deal allows LPOXY to begin a Phase II study of SIDIPREV under the FDA’s Limited Population Pathway for Antibacterial and Antifungal Development (LPAD).
Larry Sutton, MD, PhD, physician scientist and CEO of Lopoxy Therapeutics, is leading efforts to address this growing health crisis. In our interview with Sutton, he shares the science behind their innovative therapeutic, SIDIPREV, and how it could transform the way we combat this difficult-to-treat, highly recurrent infection.
Larry Sutton begins by explaining that Lopoxy's mission is not simply to treat C difficile, but to prevent it from ever happening. “There have been some people that have tried this,” he says. “Sanofi and Pfizer both tried to prevent C difficile by making vaccines, but they didn’t work in phase three. Most of the other people are just kind of resigned to the fact that you have to get it and then try to treat it. But the problem is, it’s highly recurrent, and it’s difficult to treat.”
Lopoxy believes the solution is to intervene before the infection has a chance to develop. “We think that through our technology, through raising the oxygen concentration in the gut—which is toxic to these anaerobic pathogens—we will prevent them from happening in the first place,” Sutton said.
SIDIPREV is a metered-dose oxygen delivery system specifically designed to be co-administered with antibiotics, which is the number one risk factor for developing C difficile infections. “You take these at the same time, and that increased concentration of oxygen, which is toxic to C difficile, will prevent it from causing an infection,” Sutton said.
“Anybody of any age on any antibiotic can get this infection, because it’s a spore-forming organism. We breathe in and swallow spores from fungi, pollen, and other things every day. But elderly patients are more likely to get it, not necessarily as an independent risk factor, but because the older we get, the sicker we get, and the more vulnerable we are," Sutton said.
He continued, “So the most urgent need is in hospitalized elderly patients, and that’s what we’re targeting first. There’s no other therapy to prevent these infections in this group.” Their initial clinical trials will focus on elderly patients hospitalized with pneumonia—an infection that increases the likelihood of contracting a secondary C difficile infection, especially when combined with antibiotic use.
Although, Sutton also points out that the risk extends beyond the hospital. “There are antibiotics out in the community that cause this too,” he says. “For example, like clindamycin, there’s 16% of people on clindamycin who will get C difficile infections. It’s a very high risk, and it’s a great antibiotic—it’s on the WHO’s essential medicines list—but physicians are a little reluctant to prescribe it because of the risk for C difficile.”
An important step in bringing SIDIPREV to market involves navigating the regulatory process. Sutton highlights the FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) as an important strategy for getting this innovative treatment into the hands of those who need it most. “LPAD is for situations like this, where there’s a high-risk group of people who don’t have any other therapeutic options,” Sutton said. “It’s a way to do a pivotal clinical trial and get a limited label for these high-risk people.”
If successful in their clinical trials, Sutton’s team would secure approval for SIDIPREV, but only for the specific population it’s designed to protect. “For example, if we are successful with this in elderly patients with community-acquired pneumonia who are on fluoroquinolones or ceftriaxone, we wouldn’t get a label to give it to anybody. We could only give it to those people, because they’re the high-risk ones,” Sutton explained. “But at least it gets it out there and begins to protect people.”
While the approval would be limited at first, Sutton sees this as a critical step forward. “It doesn’t stop us from going on and developing it in the more traditional way through Phase III trials,” he added. “We will do that for broader indications. But the LPAD pathway gets a way to get something on the market quickly to protect people.”
Stay tuned for part 2 of our interview coming soon.
