Zavante Therapeutics to Present ZOLYD™ Data at ASM Microbe 2017 Meeting

5/17/2017

SAN DIEGO, CA, May 17, 2017 – 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 10 posters related to investigational product candidate, ZOLYD™ (fosfomycin for injection, also known as ZTI-01), at ASM Microbe 2017 to be held June 1-5, 2017 in New Orleans.

ZOLYD is a first-in-class injectable epoxide antibiotic with a differentiated mechanism of action that is intended to combat serious, life-threatening infections in the hospital setting. Research to be presented at ASM Microbe 2017 includes several posters that will highlight new in vitro evidence of ZOLYD’s broad spectrum of bactericidal activity against both Gram-negative and Gram-positive bacteria, including activity against most contemporary multi-drug resistant (MDR) strains. In addition, two in vitro studies that show potentially high rates of synergy and improved bacterial killing when ZOLYD is combined with multiple antimicrobial agents are to be presented. Zavante’s Phase 1 safety, tolerability and pharmacokinetic study will also be presented for the first time. In April, the company reported positive results from its pivotal, double-blind Phase 2/3 trial designed to evaluate the safety and efficacy of ZOLYD in the treatment of hospitalized adults with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP).

Poster details are as follows:

Friday, June 2, 2017, 12:45 – 2:45 p.m.

Session 057 – Antimicrobial Susceptibility Testing I

  • Poster 414: Time Kill Analyses of Concerning Gram-Negative Bacteria (GNB) by Fosfomycin Alone and in Combination with Select Antimicrobial Agents

Saturday, June 3, 2017, 12:15 – 2:15 p.m.

Session 185 – Antibacterial Resistance: In Vitro Activity and Resistance to Tigecycline, Fosfomycin and Derivatives

  • Poster 57: Fosfomycin Activity When Tested Against Gram-positive and Gram-negative US Isolates Collected by the SENTRY Antimicrobial Surveillance Program
  • Poster 61: Fosfomycin In Vitro Activity Against Bacteria with Various Mechanisms of Resistance to other Antibacterials from US Hospitals
  • Poster 63: Fosfomycin (FOS) for Injection: Activity Against Carbapenem-resistant and Ceftazidime-avibactam Resistant Enterobacteriaceae (CRE) Clinical Isolates with Diverse Resistance Mechanisms

Saturday, June 3, 2017, 12:15 – 2:15 p.m.

Session 198: Antimicrobial Pharmacokinetics: PK/PD of Existing Antimicrobial Agents

  • Poster 151: Population Pharmacokinetic (PK) Analysis of ZTI-01 (Fosfomycin for Injection) Using Phase 1 Data for ZTI-01 and Evaluation of a Phase 2/3 Sparse PK Sampling Strategy
  • Poster 152: Pharmacokinetics-Pharmacodynamics (PK-PD) Target Attainment Analyses to Support ZTI-01 (Fosfomycin for Injection) Dose Selection for Patients with Complicated Urinary Tract Infections (cUTI)
  • Poster 153: Pharmacokinetics, Safety, and Tolerability of Single Dose Intravenous and Oral Fosfomycin in Healthy Volunteers
  • Poster 154: In Vivo Pharmacodynamics of ZTI-01 (Fosfomycin for Injection) in the Neutropenic Murine Thigh Infection Model Against ESBL-positive coli (EC), Carbapenem-resistant (CR) K. pneumoniae (KPN), and P. aeruginosa (PSA)

Saturday, June 3, 2017, 12:15 – 2:15 p.m.

Session 205: Antimicrobial Susceptibility Testing II

  • Poster 406: Evaluation of the Antimicrobial Activity of Fosfomycin When Combined with Selected Antimicrobial Agents and Tested Against Bacterial Isolates Using Checkerboard Methods
  • Poster 411: Correlation of Reference Agar Dilution MIC Values and Kirby-Bauer Disk Diffusion Testing for Fosfomycin Against Gram-positive and Gram-negative Bacteria

About ZOLYD (fosfomycin for injection, also known as ZTI-01) 
ZOLYD is an investigational, first-in-class injectable epoxide antibiotic with a broad spectrum of bactericidal Gram-negative and Gram-positive activity, including activity against most contemporary MDR strains that are of particular concern to public health. ZOLYD 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 recently reported that ZOLYD met the primary endpoint of statistical non-inferiority to piperacillin/tazobactam in the pivotal ZEUS™ clinical trial in patients with cUTI or AP.

The U.S. Food and Drug Administration (FDA) granted Fast Track designation and Qualified Infectious Disease Product (QIDP) designation for the investigation of ZOLYD 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 ZOLYD 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.

ZOLYD 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 the anticipated effectiveness of ZOLYD in treating serious infections in hospitalized patients, including those caused by MDR pathogens, as well as ZOLYD’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 an NDA for ZOLYD; unanticipated delays that may occur, or unanticipated findings that may emerge, in analyzing the data from the ZEUS clinical trial; the company’s ability to successfully complete necessary manufacturing and related development activities for ZOLYD 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 ZOLYD, if approved by FDA; and potential changes in the FDA’s regulatory policies that could negatively impact FDA approval of ZOLYD or the Fast-track or QIDP designations granted by FDA for ZOLYD. 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.

ZOLYD, ZEUS and ZAVANTE are trademarks or registered trademarks of Zavante Therapeutics, Inc.

Investor Contact:
Kevin Finney
Zavante Therapeutics
kfinney@zavante.com
858-299-4990

Media Contact:
Pam Lord
Canale Communications
pam@canalecomm.com
619-849-6003