The team at Zavante Therapeutics had a very simple goal.
Armed with $45 million in investor backing, they took a broad spectrum antibiotic that’s been used in various countries around the world — outside the US — and put it through a late-stage, head-to-head, non-inferiority trial against a combo antibiotic that’s already in use in the US.
And they are claiming a win, prepping an FDA application now for a new antibiotic in an increasingly drug-resistant world as they consider their options: marketing it themselves or selling it to a player in the field.
By the time they get through the NDA process, CEO Ted Schroeder tells me, they will have spent “every nickel” of their $45 million.
Investigators recruited 465 patients, giving their antibiotic Zolyd (fosfomycin for injection, or ZTI-01) in 1-hour IV infusions three times a day versus a somewhat smaller dose of IV piperacillin (penicillin)/tazobactam at the same schedule.
Here is the bottom line, presented by Zavante:
In the study, ZOLYD met the primary endpoint of statistical non-inferiority compared to piperacillin/tazobactam, with an overall success rate of 64.7% (119/184 patients) versus 54.5% (97/178 patients), respectively, a treatment difference of 10.2% (95% CI: -0.4, 20.8). Clinical cure rates were high and similar between treatment groups (90.8% vs. 91.6%, respectively).
Fosfomycin was launched in Spain and then started making the rounds until Big Pharma introduced new classes of antibiotics and basically declared the problem of antibiotic development fixed, says Schroeder, a longtime biotech exec with a lengthy stint at Elan on the resume. Then those mainstream antibiotics dominated the market until drug resistance began to become a serious threat. And fosfomycin began to make a comeback, attracting his attention as a likely candidate for a first-US approval.
The key, he adds, was the passage of the GAIN Act, which gives this antibiotic a shot at eight years of market exclusivity.
Schroeder says he and his team have the experience to field this antibiotic themselves. Or they might sell it, as seems the most likely successful outcome. An application will have to wait until H1 2018, so they can finish the work.
It’s a big market, says Schroeder, but it’s also a market dominated by cheap, old antibiotics. Schroeder, though, feels that his antibiotic could come into frequent play as a combo, tied to other antibiotics as intensive care physicians look for a knockout blow against infections.
“I do think its a really interesting opportunity to bring such a useful product forward in such an efficient way,” says the CEO. Now he has to complete the process.
“In an environment of rapidly increasing resistance, safe and effective antibiotics with activity against MDR pathogens are sorely needed,” said Keith Kaye, Professor of Medicine, University of Michigan. “If approved, ZOLYD’s unique mechanism of action and broad spectrum of activity would add to the treatment armamentarium when treating seriously ill patients in the hospital.”
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