Zavante Therapeutics Reports ZOLYD™ Broad Spectrum Activity and Synergy With Multiple Antibiotics; in vitro Studies Presented at ASM Microbe 2017 Meeting

6/5/2017

SAN DIEGO, CA, June 5, 2017 – Zavante Therapeutics, Inc., a biopharmaceutical company focused on developing novel therapies to improve the outcomes of hospitalized patients, today announced that multiple in vitro studies provide support for greater bacterial killing when ZOLYD™ (fosfomycin for injection, also known as ZTI-01) is combined with certain other antibiotics. Research being presented at this week’s ASM Microbe 2017 Meeting also demonstrates that ZOLYD is active in vitro against several Gram-negative bacteria that are resistant to certain newer antibiotics.

Researchers evaluated in vitro activity of ZOLYD against nearly 50 clinical ceftazidime-avibactam resistant Enterobacteriaceae (CRE) isolates. Utilizing U.S. breakpoints for oral fosfomycin for comparison, 47 (94%) of the CRE isolates were highly susceptible to ZOLYD, indicating the investigational antibiotic is active against CRE isolates for which there are currently no active beta-lactam antibiotics. (Poster #63)

The activity of ZOLYD was evaluated when combined with multiple antimicrobial agents and tested using checkerboard methods against 40 multi-drug resistant (MDR) bacterial isolates. Seventy percent of all combinations with ZOLYD demonstrated synergy or partial synergy, which indicates combination therapy with ZOLYD may be beneficial. The highest rates of synergy were seen when ZOLYD was combined with piperacillin-tazobactam, cephalosporins, meropenem, or penicillin. No antagonism was observed with any of the combinations. (Poster #406)

To further study enhanced bacterial killing of ZOLYD in combination with other antimicrobial agents, time-kill analyses were performed on select Gram-negative bacteria with ZOLYD and previously demonstrated synergistic comparator agents. The combination of ZOLYD and selected beta-lactams provided enhanced killing and in vitro synergy against concerning Gram-negative bacteria, including two Klebsiella pneumoniae isolates, two Pseudomonas aeruginosa isolates (non-MDR), and one Acinetobacter baumannii isolate (MDR). (Poster #414)

“ZOLYD exhibited even greater bacterial killing when used in combination with a number of frequently used antibiotics, which indicates it may play a role as both a first-line agent or in combination with other antibiotics to augment patient care in the hospital setting,” said Cornelius (Neil) J. Clancy, M.D., Associate Professor of Medicine, University of Pittsburgh and Chief, Infectious Diseases Section, Veteran’s Administration Pittsburgh Health Care System.

“Combining antibiotics is frequently employed and offers a comprehensive approach to treating patients who may have deep-seated infections caused by multi-drug resistance bacteria. We are pleased to consistently see these results of ZOLYD’s synergy and in many cases, restoration of susceptibility to several of our older and commonly used antibiotics,” said Evelyn J. Ellis-Grosse, Ph.D., Chief Scientific Officer of Zavante Therapeutics.

Zavante and its research collaborators presented 10 posters related to ZOLYD at ASM Microbe 2017. A complete list is available at www.Zavante.com and abstracts are available from the ASM Microbe 2017 website.

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.

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 “may” 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, either alone or in combination with other antibiotics, in treating serious infections in hospitalized patients, including those caused by MDR pathogens. 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