San Diego’s Zavante Therapeutics just closed out a hefty $45 million Series A to push its antibiotic through clinical trials. The company plans to introduce fosfomycin, an IV antibiotic that was actually approved several years ago abroad, to the U.S. market, thanks to its potential in treating superbugs.
The round consists of $35 million from new investors, which include Frazier Healthcare Partners, Longitude Capital and Aisling Capital, as well as $10 million from an earlier tranche. The round will fund a single pivotal trial for fosfomycin, so as to prove the old drug’s efficacy to U.S. regulators.
So why is Zavante brushing the dust off fosfomycin? After all, it was actually first tested in the 1960s in Spain, but had been ruled as fairly ineffective in comparison to other antibiotics on the market.
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However, there’s nothing like fosfomycin on the U.S. market, CEO Ted Schroeder said in a phone interview. The drug’s a first-in-class epoxide injectable antibiotic that’s shown, for decades, activity against both Gram-positive and Gram-negative bacteria – including multi-drug resistant pathogens.
The forthcoming trial, called the ZEUS Study, will test fosfomycin in hard-to-treat urinary tract infections. It should be a fairly straightforward study.
“There are literally thousands of publications showing the clinical use of this product, and all of that informs our trial design, and how we’ll use fosfomycin,” Schroeder said. “All of this gives us more confidence that we understand the characteristics of the drug and how it works.”
Fosfomycin is better understood these days than in years past – particularly its safety profile. The drug, Schroeder said, is so safe that it can be used in very high doses; this kind of escalation improves its efficacy and renders it potent against superbugs.
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The drug’s already received QIDP designation from the FDA, which expands its marketing exclusivity window in the U.S. – despite the fact that fosfomycin has been approved and has been used abroad for nearly 50 years. Schroeder says that upon approval, which could happen as early as 2018, Zavante should have marketing exclusivity for eight years, thanks to Congress’ GAIN Act.
“In some ways, this is better than having a patent,” Schroeder said. “You can’t really challenge regulatory exclusivity.”
