SAN DIEGO – May 21, 2018 – Zavante Therapeutics, Inc., a biopharmaceutical company focused on developing novel therapies to improve the outcomes of hospitalized patients, today announced that the company and its research collaborators will present seven posters related to Zavante’s investigational product, fosfomycin for injection, at ASM Microbe 2018, to be held June 7-11, 2018 in Atlanta. The company also announced the U.S. Food and Drug Administration (FDA) granted conditional acceptance of CONTEPO™ as the U.S. trade name for fosfomycin for injection (formerly known as ZOLYD™ and ZTI-01), pending approval of a New Drug Application for the product candidate.
“We believe we will have the rare opportunity to offer a first-in-class injectable antibiotic that, if approved, would provide U.S. hospitals a new option to combat difficult to treat complicated urinary tract infections suspected to be caused by multi-drug resistant bacteria,” said Ted Schroeder, President and Chief Executive Officer of Zavante. “In our clinical study, CONTEPO™ achieved a high overall cure rate in complicated urinary tract and acute pyelonephritis infections. As increasing drug resistance limits physicians’ choices, we believe there’s an urgency to add antibiotics with differentiated mechanisms of action to hospital formularies.”
Research to be presented at ASM Microbe 2018 includes four posters that further highlight CONTEPO’s in vitro evidence of broad spectrum activity against both Gram-negative and Gram-positive bacteria, including most contemporary multi-drug resistant (MDR) strains, due to the antibiotic’s unique mechanism of action. In addition, three in vitro studies will highlight the potentially high rates of synergy and improved bacterial killing when CONTEPO is combined with multiple antimicrobial agents. Zavante previously reported that in its pivotal, double-blind ZEUS Phase 2/3 trial, CONTEPO met the primary endpoint of statistical non-inferiority to piperacillin/tazobactam in the treatment of hospitalized adults with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP).
Poster details are as follows:
Friday, June 8, 2018, 11:00 – 1:00 p.m.
Session 056 – Antimicrobial PK/PD & General Pharmacology: In vitro Models
Saturday, June 9, 2018, 11:00 – 1:00 p.m.
Session 236 – Pharmacological Studies of Antimicrobial Agents Pre-NDA (Phase 2/3): New Agents between Phase 2 and FDA Approval
About CONTEPO (fosfomycin for injection, also known as ZTI-01)
CONTEPO, previously referred to as ZOLYD, is an investigational, first-in-class injectable epoxide antibiotic with a broad spectrum of activity in vitro against Gram-negative and Gram-positive bacteria, including activity against most contemporary MDR strains that are of particular concern to public health. CONTEPO has a differentiated mechanism of action that acts at an earlier step in cell wall synthesis inhibition, providing activity against pathogens that are often resistant to other classes of antibiotics. Zavante reported that CONTEPO met the primary endpoint of statistical non-inferiority to piperacillin/tazobactam in the pivotal ZEUS clinical trial in hospitalized patients with cUTI or AP.
The FDA granted Fast Track designation and Qualified Infectious Disease Product (QIDP) designation for the investigation of CONTEPO for the following indications: cUTI, hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), acute bacterial skin and skin structure infections (ABSSSI), complicated intra-abdominal infections (cIAI). These designations make CONTEPO eligible for certain incentives available for the development of new antibiotics, including priority FDA review and an additional five years of market exclusivity under the Generating Antibiotic Incentives Now (GAIN) Act. The company anticipates filing a New Drug Application for CONTEPO in the second half of 2018.
CONTEPO™ (fosfomycin for injection) is an investigational medication that has not been approved by the FDA for any indication.
About Zavante Therapeutics, Inc.
Zavante Therapeutics, Inc. is a privately-held, late clinical-stage biopharmaceutical company focused on developing novel therapies to improve the outcomes of hospitalized patients. Additional information is available at www.zavante.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of U.S. federal securities laws. Words such as “will,” “intended,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements contained in this press release include statements about our plans to offer CONTEPO to the U.S. hospital market, the anticipated effectiveness of CONTEPO in treating serious cUTI and AP infections in hospitalized patients, including those caused by MDR pathogens, as well as CONTEPO’s potential synergy with other antimicrobial agents, safety and tolerability. Forward-looking statements are not historical facts or assurances of the company’s future performance, but are based on management’s current beliefs, expectations and assumptions and are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and may be outside of the company’s control. Because the company’s actual results and financial condition may differ materially from those indicated in the forward-looking statements, you should not rely on any such forward-looking statements. Important factors that could cause the company’s actual results to differ materially from those indicated in this release include, among others, the following: whether the results of the company’s ZEUS clinical trial are deemed to be sufficient by FDA to support approval of a New Drug Application (NDA) for CONTEPO; unanticipated delays that may occur, or unanticipated findings that may emerge, in analyzing the data from the ZEUS clinical trial or in additional nonclinical studies for the product candidate required by FDA; whether the FDA will grant final approval of the tradename, CONTEPO, upon submission of an NDA for the product candidate, the company’s ability to successfully complete necessary manufacturing and related development activities for CONTEPO on time and at reasonable costs; the company’s ability to obtain additional financing required to complete development activities and prepare for the commercialization of CONTEPO, if approved by FDA; and potential changes in the FDA’s regulatory policies that could negatively impact FDA approval of CONTEPO or the Fast-track or QIDP designations granted by FDA for CONTEPO. Forward-looking statements contained in this press release are based only on information currently available to the company and speak only as of the date made. Zavante undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
CONTEPO, ZEUS, ZOLYD and ZAVANTE are trademarks or registered trademarks of Zavante Therapeutics, Inc.
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