With a new $10 million equity round in hand, San Diego biopharma startup Zavante Therapeutics will kick off clinical trials next quarter for its injectable antibiotic that treats complicated urinary tract infections.
Its lead drug, ZTI-01, also received Fast Track status from FDA for three other indications – though targeting UTIs is its primary focus.
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The forthcoming clinical trial for ZTI-01 will evaluate the antibiotic’s efficacy versus piperacillin and tazobactam in treating UTIs, including acute pyelonephritis, in hospitalized adults.
Zavante says that ZTI-01 is a novel antibiotic that has both Gram-positive and Gram-negative activity – and is showing efficacy in treating dangerous Carbapenem Resistant Enterobactericeae, or CRE. The company writes of its regulatory milestones:
In September 2014, the FDA initially granted QIDP designation for ZTI-01 for the indication of cUTI. In December 2015, the FDA expanded the QIDP designations to include the following indications: complicated intra-abdominal infections (cIAI), hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP), and acute bacterial skin and skin structure infections (ABSSSI). The QIDP designations should enable Zavante to benefit from certain incentives for the development of new antibiotics, including priority review, and a five-year extension of market exclusivity under the GAIN Act.
There’s a huge need for new entrants into the antibiotic space, given the growing resistance of bacteria we’re seeing across healthcare – exemplified by the recent UCLA superbug scare where CRE infected reusable duodenoscopes.
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