Cam Garner
Chairman
Pipeline
Therapeutic Focus
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Zavante is developing novel medicines for the treatment of diseases that affect patients in the hospital setting.
Our lead product candidate, ZOLYD™ (fosfomycin for injection, previously referred to as ZTI-01), is an investigational, first-in-class injectable antibiotic under development to combat serious, life-threatening infections, including those due to multi-drug resistant (MDR) Gram-negative and Gram-positive bacteria. ZOLYD is being developed as a foundational antibiotic for hospitalized patients with infections caused by suspected or confirmed MDR pathogens. Zavante is initially developing ZOLYD to treat complicated urinary tract infections (cUTIs) and has identified additional indications for possible development.
Therapeutic Focus
Growing antimicrobial resistance creates a significant demand for novel therapies. Bacterial resistance to currently available antimicrobials has reached alarmingly high levels, resulting in a global health crisis. To combat this threat, antibiotic treatment options with differing mechanisms of action are critically needed, particularly agents with activity against MDR Gram-negative bacteria. The lack of options for these life-threatening MDR pathogens has prompted national medical agencies and societies, to urgently call for help in bringing forth new antimicrobials.
New tools needed in the fight against MDR pathogens. The CDC has estimated at least 2 million illnesses per year and 23,000 deaths in the U.S. are due to infections caused by MDR pathogens. The difficulty in treating MDR infections is a substantial burden on the U.S. healthcare system; research by the Infectious Diseases Society of America indicates the overall cost related to antibiotic-resistant pathogens in the U.S. ranges from $21 billion to $34 billion annually, and requires an additional eight million hospital days per patient. Development and FDA approval of innovative new classes of antibiotics targeting MDR pathogens in the hospital is an important objective for government policy makers and health care systems across the United States.
Pipeline
ZOLYD™(Fosfomycin for injection) | Pre-clinical | Phase 1 | Phase 2 | Phase 3 |
|---|---|---|---|---|
| cUTI | ||||
| cIAI | ||||
| ABSSSI | ||||
| HABP/VABP | ||||
| Other Unmet Need Indications |
ZOLYDTM
ZOLYD™ is an investigational, first-in-class epoxide antibiotic with a broad spectrum of bactericidal Gram-negative and Gram-positive activity, including activity against most contemporary MDR strains that threaten hospitalized patients. Fosfomycin IV has an extensive history from markets outside the U.S., where it has been utilized for over 40 years in nine indications. ZOLYD utilizes a new dosing approach, developed by Zavante, to optimize the compound’s pharmacokinetics and pharmacodynamics.
The company believes that these attributes, along with the positive clinical experience worldwide, support ZOLYD as a first-line treatment for complicated urinary tract infections (cUTI) suspected to be caused by MDR pathogens. Approximately 25% of cUTIs are caused by MDR bacteria and limited treatment options are available. In addition, non-clinical data have shown that ZOLYD acts synergistically with certain other antibiotics to improve bacterial killing and restore susceptibility to agents otherwise demonstrating resistance.
The ZOLYD development program is initially focused on obtaining regulatory approval for the treatment of cUTI, including acute pyelonephritis, with the pivotal ZEUS™ study (ZTI-01 Efficacy and Safety study). In the ZEUS study, ZOLYD met the primary endpoint of statistical non-inferiority to piperacillin/tazobactam in this patient population. Zavante expects to file a New Drug Application utilizing the FDA’s 505(b)(2) pathway in early 2018.
The FDA has granted ZOLYD Qualified Infectious Disease Product (QIDP) and Fast Track designations for:
- Complicated urinary tract infections (cUTI)
- Complicated intra-abdominal infections (cIAI)
- Hospital-acquired bacterial pneumonia (HABP) /
Ventilator-associated bacterial pneumonia (VABP) - Acute bacterial skin and skin structure infections (ABSSSI)
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 found by the U.S. Food and Drug Administration to be safe or effective for any indication.
The lack of available and effective antibiotics for life-threatening multidrug-resistant pathogens has created an important unmet medical need that is widely acknowledged by national medical agencies and societies. An antibiotic with a unique mechanism of action like ZTI-01 would be an important addition to our antibacterial armamentarium when treating seriously ill patients in the hospital.
– George Drusano, MD, professor of medicine and director of the Institute for Therapeutic Innovation, University of Florida
Scientific Data
Population Pharmacokinetic (PPK) Analysis of ZTI-01 (Fosfomycin for Injection) Using Data from Healthy Subjects and Patients with Complicated Urinary Tract Infections (cUTI) (Michael Trang, Pharm.D., et al, ID Week, October 7, 2017)
Intravenous Fosfomycin (ZTI-01) for the Treatment of Complicated Urinary Tract Infections (cUTI) Including Acute Pyelonephritis (AP): Results from a Multi-center, Randomized, Double-Blind Phase 2/3 Study in Hospitalized Adults (ZEUS) (Paul B Eckburg, MD, et al, ID Week, October 7, 2017)
Safety Results from the ZEUS Study: Multi-center, Randomized, Double-Blind Phase 2/3 Study in Hospitalized Adults with Complicated Urinary Tract Infections (cUTI) Including Acute Pyelonephritis (AP) who Received Intravenous Fosfomycin (ZTI-01) (Paul B Eckburg, MD, et al, ID Week, October 7, 2017)
Per Pathogen Outcomes from the ZEUS study, a Multi-center, Randomized, Double-Blind Phase 2/3 Study of ZTI-01 (fosfomycin for injection) versus Piperacillin-Tazobactam (P-T) in the Treatment of Patients with Complicated Urinary Tract Infections (cUTI) including Acute Pyelonephritis (AP) (David Skarinsky, BS, et al, ID Week, October 7, 2017)
Phenotypic Antibiotic Resistance in ZEUS: A Multi-center, Randomized, Double-Blind Phase 2/3 Study of ZTI-01 versus Piperacillin-Tazobactam (P-T) in the Treatment of Patients with Complicated Urinary Tract Infections (cUTI) including Acute Pyelonephritis (AP) (Evelyn J. Ellis-Grosse, Ph.D., et al, ID Week, October 7, 2017)
In vitro Activity of Fosfomycin, Alone and Combined with Cefepime and Meropenem, Against Carbapenemase-Producing Gram-Negative Bacteria (Nathan P. Wiederhold, PharmD, et al, ID Week, October 6, 2017)
ZTI-01 Treatment Improves Survival of Animals Infected with Multidrug Resistant Pseudomonas aeruginosa (Evelyn J. Ellis-Grosse, Ph.D., et al, ID Week, October 6, 2017)
Fosfomycin (FOS) Plus Meropenem (MER) Suppresses Resistance Emergence Against P. aeruginosa (PA) PAO1 in the Hollow Fiber Infection Model (HFIM) (Arnold Louie, M.D., et al, ID Week, October 6, 2017)
Fosfomycin Activity When Tested Against Gram-positive and Gram-negative US Isolates Collected by the SENTRY Antimicrobial Surveillance Program (R. K. Flamm, et al, ASM Microbe, June 3, 2017)
Fosfomycin In Vitro Activity Against Bacteria with Various Mechanisms of Resistance to other Antibacterials from US Hospitals (D. Shortridge, et al, ASM Microbe, June 3, 2017)
Fosfomycin (FOS) for Injection: Activity Against Carbapenem-resistant and Ceftazidime-avibactam Resistant Enterobacteriaceae (CRE) Clinical Isolates with Diverse Resistance Mechanisms (C. Clancy, et al, ASM Microbe, June 3, 2017)
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 (M. Trang, et al, ASM Microbe, June 3, 2017)
Pharmacokinetics-Pharmacodynamics (PK-PD) Target Attainment Analyses to Support ZTI-01 (Fosfomycin for Injection) Dose Selection for Patients with Complicated Urinary Tract Infections (cUTI) (S. M. Bhavnani, et al, ASM Microbe, June 3, 2017)
Pharmacokinetics, Safety, and Tolerability of Single Dose Intravenous and Oral Fosfomycin in Healthy Volunteers (E. Wenzler, et al, ASM Microbe, June 3, 2017)
In Vivo Pharmacodynamics of ZTI-01 (Fosfomycin for Injection) in the Neutropenic Murine Thigh Infection Model Against ESBL-positive E. coli (EC), Carbapenem-resistant (CR) K. pneumoniae (KPN), and P. aeruginosa (PSA) (A. J. Lepak, et al, ASM Microbe, June 3, 2017)
Evaluation of the Antimicrobial Activity of Fosfomycin When Combined with Selected Antimicrobial Agents and Tested Against Bacterial Isolates Using Checkerboard Methods (P. R. Rhomberg, et al, ASM Microbe, June 3, 2017)
Correlation of Reference Agar Dilution MIC Values and Kirby-Bauer Disk Diffusion Testing for Fosfomycin Against Gram-positive and Gram-negative Bacteria (R. K. Flamm, et al, ASM Microbe, June 3, 2017)
Time Kill Analyses of Concerning Gram-negative Bacteria (GNB) by Fosfomycin Alone and in Combination with Select Antimicrobial Agents (R. K. Flamm, et al, ASM Microbe, June 2, 2017)
Team
Ted Schroeder
President, Chief Executive Officer, Director
Kevin Finney
Chief Operating Officer
Evelyn Ellis-Grosse, PhD
Chief Scientific Officer
Cam Gallagher
Chief Business Officer
Richard Vincent
Chief Financial Officer
Robert DiVasto, P.E.
Senior Vice President, Manufacturing and Supply
Kristina Haeckl
Vice President of Regulatory Affairs and Quality Systems
David Skarinsky
Vice President of Clinical Operations
Paul Eckburg, MD
Acting Chief Medical Officer
Kim Sweeney
Senior Director, Medical Affairs
Board of Directors
Ted Schroeder
President, Chief Executive Officer, Director
Patrick Heron
Director
David Hirsch, MD, PhD
Director
Stephen Newman, MD
Independent Board Member
Andrew N. Schiff, MD
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