Za­vante hits the fin­ish line, de­clar­ing a piv­otal win for its an­tibi­ot­ic now head­ed (even­tu­al­ly) to the FDA

Za­vante CEO Ted Schroed­er

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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By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

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Announced just a day after the NIH and the University of Nebraska Medical Center registered their US-based trial online, Gilead’s program will comprise two studies enrolling around 1,000 patients beginning in March. They will recruit primarily in Asian countries but will also include patients from other locations with “high numbers of diagnosed cases,” the company said.

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Anthony Fauci (AP Images)

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Off it goes.

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