A Phase 3 Study to Evaluate Cefepime-taniborbactam Compared to Meropenem in Adults with Ventilator Associated Bacterial Pneumonia (VABP) or Ventilated Hospital Acquired Bacterial Pneumonia (vHABP)

This is a Phase 3, randomized, multicenter, double-blind, non-inferiority study to evaluate the efficacy and safety of cefepime-taniborbactam compared to meropenem in patients ≥ 18 years of age with ventilated HABP or VABP.

Start Date01 Jun 2025

Sponsor / Collaborator

Venatorx Pharmaceuticals, Inc.

[+1]

NCT04951505

/ CompletedPhase 1

A Phase 1 Study to Evaluate the Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects

This is a single-center, open-label study to assess the safety and intrapulmonary pharmacokinetics of cefepime and taniborbactam in healthy adult male and female subjects. Thirty subjects will receive a total of 6 doses of cefepime-taniborbactam (2 g cefepime/0.5g taniborbactam) administered intravenously every 8 hours. Following the sixth dose of cefepime-taniborbactam, subjects will be assigned to one of six bronchoscopy sampling times.

Start Date29 Jun 2021

Sponsor / Collaborator

Venatorx Pharmaceuticals, Inc.

CTR20191681

/ CompletedPhase 1

头孢吡肟/VNRX-5133在中国健康受试者中单剂和多剂静脉输注给药的药代动力学、安全性和耐受性的1期临床试验

[Translation] Phase 1 clinical trial of the pharmacokinetics, safety, and tolerability of single and multiple intravenous infusions of cefepime/VNRX-5133 in healthy Chinese subjects

1. 评价中国健康受试者中头孢吡肟/VNRX-5133单剂和多剂静脉（IV）输注给药的药代动力学。 2. 评价中国健康受试者中头孢吡肟/VNRX-5133单剂和多剂静脉输注给药的安全性和耐受性。

[Translation]

1. To evaluate the pharmacokinetics of single and multiple intravenous (IV) infusions of cefepime/VNRX-5133 in healthy Chinese subjects. 2. To evaluate the safety and tolerability of single and multiple intravenous infusions of cefepime/VNRX-5133 in healthy Chinese subjects.

Start Date06 Jun 2020

Sponsor / Collaborator

Lyophilization Services of New England, Inc.

[+2]

100 Clinical Results associated with Cefepime Hydrochloride/Taniborbactam

100 Translational Medicine associated with Cefepime Hydrochloride/Taniborbactam

100 Patents (Medical) associated with Cefepime Hydrochloride/Taniborbactam

3,312

Literatures (Medical) associated with Cefepime Hydrochloride/Taniborbactam

11 Feb 2025·Journal of Biomolecular Structure and Dynamics

Mutations in V84I & A184V of bla _TEM cluster plays a pivotal role in the dynamics of Ω-loop leading to genesis of IR-TEM

Article

Author: Darji, Siddhi A. ; Rath, Soumya Lipsa ; Mandal, Nabanita ; Banerjee, Devjani

The Enterobacteriaceae family exhibits resistance to antibiotics by producing β-Lactamase. Mutations in β-Lactamase, have led to the generation of inhibitor resistant variants known as IR-TEM. In the present study, IR-TEM β-Lactamase of Enterobacter hormaechei and Enterobacter asburiae was compared. To investigate the mechanism behind the conferred mutation, we studied its interaction with Clavulanic acid, (β-Lactamase inhibitor) with different lineages of TEM and IR-TEM. We found that Clavulanic acid quickly left the binding pockets of both variants using molecular dynamics (MD) simulations. Interestingly, mutations at the V84I and A184V positions were found to drastically influence the protein dynamics. Mutating the residues at V84I and A184V positions by computational mutagenesis in Enterobacter hormaechei, it was observed that the residues on the Ω-loop as well as a few downstream residues were primarily involved in generating resistance towards inhibitors by conferring increased flexibility to the loop. This further strongly supports the notion that inhibitor resistance in β-Lactamase is conferred through allosteric regulation, wherein mutations in positions 84 and 184 may play an important role in regulating the movement of the Ω-loop. These two positions determine the lineage pattern between two clusters in TEM-1 and TEM-116. To date, no reports have been made regarding the importance of these mutations and their dynamics in Ω-loop.Communicated by Ramaswamy H. Sarma.

01 Feb 2025·The Journal of Pharmacology and Experimental Therapeutics

Chronic activation of β-adrenergic receptors leads to tissue water and electrolyte retention

Article

Author: Akumwami, Steeve ; Rahman, Md Moshiur ; Kitada, Kento ; Fujisawa, Yoshihide ; Nishiyama, Akira ; Kitamura, Hiroaki ; Kundo, Netish Kumar ; Morishita, Asahiro ; Ogino, Yuichi ; Rahman, Asadur

Beta-adrenergic receptors (β-AR) are expressed on the membranes of various cell types and their activation affects body water balance by modulating renal sodium and water excretion, cardiovascular function and metabolic processes. However, β-AR-associated body fluid imbalance has not been well characterised. In the present study, we hypothesized that chronic β-AR stimulation increases electrolyte and water content at the tissue level. We evaluated the effects of isoproterenol, a non-selective β-AR agonist, on electrolyte and water balance at the tissue level. Continuous isoproterenol administration for 14 days induced cardiac hypertrophy, associated with sodium-driven water retention in the heart, increased the total body sodium, potassium and water contents at the tissue level, and increased the water intake and blood pressure of the mice. There was greater urine output in response to the isoproterenol-induced body water retention. These isoproterenol-induced changes were reduced by propranolol, a non-selective beta-receptor inhibitor. Isoproterenol-treated mice even without excessive water intake had higher total body electrolyte and water contents, and this tissue water retention was associated with lower dry body mass, suggesting that β-AR stimulation in the absence of excess water intake induces catabolism and water retention. These findings suggest that β-AR activation induces tissue sodium and potassium retention, leading to body fluid retention, with or without excess water intake. This characterisation of β-AR-induced electrolyte and fluid abnormalities improves our understanding of the pharmacological effects of β-AR inhibitors. Significance Statement We have shown that chronic β-AR stimulation causes cardiac hypertrophy associated with sodium-driven water retention in the heart and increases the accumulation of body sodium, potassium and water at the tissue level. This characterisation of the β-AR-induced abnormalities in electrolyte and water balance at the tissue level improves our understanding of the roles of β-AR in physiology and pathophysiology and the pharmacological effects of β-AR inhibitors.

01 Feb 2025·Annals of Pharmacotherapy

Decreased Hepatic Functional Reserve Increases the Risk of Piperacillin/Tazobactam-Induced Abnormal Liver Enzyme Levels: A Retrospective Case-Control Study

Article

Author: Takahashi, Masaaki ; Ooi, Hayahide ; Asai, Yuki ; Koriyama, Yoshiki

Background: Piperacillin/tazobactam (PIPC/TAZ), which is a combination of a beta-lactam/beta-lactamase inhibitor, often causes liver enzyme abnormalities. The albumin-bilirubin (ALBI) score is a simple index that uses the serum albumin and total bilirubin levels for estimating hepatic functional reserve. Although patients with low hepatic reserve may be at high risk for drug-induced liver enzyme abnormalities, the relationship between PIPC/TAZ-induced abnormal liver enzymes levels and the ALBI score remains unknown. Objective: This study aimed to elucidate the relationship between PIPC/TAZ-induced abnormal liver enzyme levels and the ALBI score. Methods: This single-center retrospective case-control study included 335 patients. The primary outcome was PIPC/TAZ-induced abnormal liver enzyme levels. We performed COX regression analysis with male gender, age (≥75 years), alanine aminotransferase level (≥20 IU/L), and ALBI score (≥−2.00) as explanatory factors. To investigate the influence of the ALBI score on the development of abnormal liver enzyme levels, 1:1 propensity score matching between the ≤−2.00 and ≥−2.00 ALBI score groups was performed using the risk factors for drug-induced abnormal liver enzyme levels. Results: The incidence of abnormal liver enzyme levels was 14.0% (47/335). COX regression analysis revealed that an ALBI score ≥−2.00 was an independent risk factor for PIPC/TAZ-induced abnormal liver enzyme levels (adjusted hazard ratio: 3.08, 95% coefficient interval: 1.207-7.835, P = 0.019). After 1:1 propensity score matching, the Kaplan-Meier curve revealed that the cumulative risk for PIPC/TAZ-induced abnormal liver enzyme levels was significantly higher in the ALBI score ≥−2.00 group (n = 76) than in the <−2.00 group (n = 76) ( P = 0.033). Conclusion and relevance: An ALBI score ≥−2.00 may predict the development of PIPC/TAZ-induced abnormal liver enzyme levels. Therefore, frequent monitoring of liver enzymes should be conducted to minimize the risk of severe PIPC/TAZ-induced abnormal liver enzyme levels in patients with low hepatic functional reserve.

News (Medical) associated with Cefepime Hydrochloride/Taniborbactam

04 Sep 2024

·www.businesswire.com

Shionogi Continues Global Commitment to Advances in Infectious Disease with Key Data Presentations from Its Expanding Product Portfolio at IDWeek 2024

FLORHAM PARK, N.J.--( BUSINESS WIRE )--Shionogi Inc., the United States subsidiary of Shionogi & Co., Ltd., (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.) will have 22 scientific presentations across the company’s infectious disease portfolio at IDWeek 2024 (October 16-19, 2024) in Los Angeles, California. Key among Shionogi’s 13 data presentations for Fetroja® (cefiderocol) will be a new real-world evidence study including approximately 1,000 patients treated with cefiderocol from across the U.S. and Europe. This trial, known as PROVE, is the largest study to evaluate cefiderocol use in hospitalized patients with serious Gram-negative infections, the majority of whom were resistant to carbapenem antibiotics. Notably, Shionogi will have two oral presentations featuring nonclinical data evaluating cefiderocol activity against some of the most difficult-to-treat bacterial strains that were resistant to antibiotics, alone and in combination with xeruborbactam, an investigational beta-lactamase inhibitor that became part of the Shionogi pipeline with the acquisition of Qpex Biopharma, Inc. (hereafter “Qpex”) by Shionogi Inc. in 2023. “Here in the U.S., a core focus of our work includes continuing to evaluate real-world outcomes associated with the use of our antibiotic for the treatment of certain Gram-negative infections and ensuring we’re meeting the educational and practical needs of our customers and their patients,” said Nate McCutcheon, President and Chief Executive Officer, Shionogi Inc. “We’re proud to make this important medication available and we also recognize that ongoing innovation is critical in infectious disease. That’s why we recently announced plans to expand our global infectious disease and antimicrobial research operations in the U.S. through Qpex with the establishment of our first U.S.-based discovery laboratory in San Diego.” Shionogi is honored to announce that Michael N. Dudley, PharmD, President and CEO of Qpex will deliver the keynote address at the Society of Infectious Diseases Pharmacists (SIDP) Annual Meeting, taking place in conjunction with IDWeek. In addition to numerous scientific presentations at IDWeek, Shionogi will once again enable the infectious disease community to join the fight and take a stand against the global public health threat of antimicrobial resistance (AMR) with a new version of its award-winning AMR Warrior experience. All visitors to Shionogi’s Booth #322 will have the opportunity to create their own AMR Warrior and use the image to spread awareness amongst their own networks and communities. Shionogi’s presence at IDWeek will also include a sponsored Learning Lounge on Friday, October 18, at 10:15 AM PT, featuring Thomas Lodise, PharmD, PhD, Professor at the Albany College of Pharmacy and Health Sciences, entitled “Fetroja® (cefiderocol): An Overview of In Vitro, Clinical, and Real-world Data.” Summary of Presentations Cefiderocol data presentations at IDWeek will include: Oral #513: Cefiderocol Retains in vitro Activity Against Enterobacterales Non-Susceptible to beta-lactam-beta-lactamase Inhibitor Combinations Poster #650: In vitro Activity of Cefiderocol and Comparator Agents Against Global Enterobacterales Isolates from Hospitalized Patients with Pneumonia Collected as Part of the SENTRY Surveillance Program (2020-2022) Poster #1099: Correlation Analysis of Cefiderocol in vitro Activity and in vivo Efficacy Against Acinetobacter baumannii Strains with Difficult-to-Read MIC Endpoints Poster #1100: Activity of Cefiderocol and Comparator Agents Against Global Isolates of Stenotrophomonas maltophilia from the SENTRY Antimicrobial Surveillance Program (2020–2023) Poster #1360: Activity of Cefiderocol Against Carbapenem Non-susceptible Enterobacterales, Including Molecularly Characterized Multidrug-resistant Clinical Isolates, Causing Infections in United States Hospitals (2020–2023) Poster #1361: Cefiderocol Activity Against Pseudomonas aeruginosa , Including Resistant Subsets and Isolates Carrying Carbapenemase beta-lactamase Genes, from United States Hospitals (2020–2023) Poster #1362: Cefiderocol Activity Against Carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex, Including Molecularly Characterized Clinical Isolates, Causing Infections in United States Hospitals (2020–2023) Poster #1363: Cefiderocol Activity Against Clinical Enterobacterales Isolates Carrying Metallo-beta-lactamase Genes in United States and European Hospitals (2020–2023) Poster #1364: Cefiderocol Activity Against Pseudomonas aeruginosa Clinical Isolates Carrying Metallo-beta-lactamase Genes in United States and European Hospitals (2020–2023) Poster #1472: Cefiderocol Remains Highly Active Against Carbapenemase-Producing Enterobacterales Poster #1475: Real-World Effectiveness and Safety of Cefiderocol in the Treatment of Patients with Serious Gram-negative Bacterial Infections: Results of the PROVE Chart Review Study Poster #1484: In vitro Activity of Cefiderocol and Comparator Agents Against Non-fermentative Gram-negative Bacilli Isolated from Patients Hospitalized with Pneumonia as part of the SENTRY Global Surveillance Program (2020-2022) Poster #1530: Evaluation of Phenotypic Cross-Resistance Between Cefiderocol and beta-lactam/beta-lactamase Inhibitor Combinations Against Pseudomonas aeruginosa Isolates from US Medical Centers Xeruborbactam data presentations at IDWeek will include: Oral #514: The Impact of Xeruborbactam on in vitro Activity of Cefiderocol Against a Panel of Acinetobacter baumannii Enriched in Isolates with Reduced Cefiderocol Susceptibility Poster #1110: The Impact of Xeruborbactam on in vitro Activity of Cefiderocol Against a Panel of Enterobacterales Enriched with Isolates with Reduced Cefiderocol Susceptibility For Full Prescribing Information for Fetroja® (cefiderocol), including approved Indications and Safety Information, please visit https://www.shionogi.com/content/dam/shionogi/si/products/pdf/fetroja.pdf . Shionogi’s scientific contributions at IDWeek will also include seven poster presentations featuring clinical, nonclinical and real-world evidence from its COVID-19 franchise. For more information, including a complete list of abstracts, please visit https://idweek.org/program/ . IDWeek attendees can learn more about Shionogi at Booth #322. About Shionogi in Infectious Disease Since 1953, Shionogi has been a leader in infectious disease discovery and commercialization. Our R&D story extends beyond antibiotics to include novel medications for HIV and influenza. Today, our global pipeline includes investigational agents developed to address global health challenges including antimicrobial resistance, COVID-19, influenza, rare fungal diseases and respiratory syncytial virus. As part of our commitment to addressing unmet medical needs, Shionogi is partnering with several non-governmental organizations to increase equitable access to our medications worldwide. Shionogi has a landmark license and technology transfer agreement for cefiderocol with Global Antibiotic Research and Development Partnership (GARDP) and a collaboration agreement with the Clinton Health Access Initiative (CHAI) to transform the landscape of access to antibiotics in many low-income countries, most lower middle- and upper middle-income countries, and select high-income countries. About Shionogi Inc. Shionogi Inc. is a U.S. subsidiary of Shionogi & Co., Ltd., a Japanese research-driven pharmaceutical company committed to developing innovative medicines that address unmet medical needs for people worldwide. Since 1878, we have been harnessing the full potential of science to address global health challenges. Over the past six decades, we have discovered several novel antibiotics and medications for HIV and influenza. Today, we’ve focused on developing antibiotics for infections due to serious Gram-negative bacteria and antivirals for COVID-19. In addition to infectious disease, we are also advancing rare disease clinical programs in Fragile X syndrome and Pompe disease. Learn more at Shionogi.com . About Qpex Biopharma Inc., a Shionogi Group Company Qpex Biopharma, Inc. is a resistance-focused infectious disease company on a mission to make both a dramatic and sustainable improvement in patient care across both inpatient and outpatient settings. Advancing a robust portfolio of best-in-class, clinical-stage products, the company’s lead program is based on xeruborbactam, an investigational beta-lactamase inhibitor discovered by Qpex scientists. For more information, please visit www.qpexbio.com . Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

License out/inAcquisitionClinical Study

23 May 2024

·www.outsourcing-pharma.com

What can pharma companies do to get promising antimicrobials to the frontlines of drug resistance?

According to the report, the race to create antibiotics and antifungals to conquer superbugs is falling perilously short, which the authors say is putting people across the world at risk. However, a shift in research and development (R&D), including investment in access and stewardship planning, can make a significant impact against antimicrobial resistance (AMR). As most large research-based pharmaceutical companies are no longer active in antimicrobial research and development (R&D), there are very few new treatments making it to market, leaving patients vulnerable to the rapid spread of AMR. Despite this reality, a handful of projects in late-stage clinical development could have a significant impact. Difficult-to-treat invasive, rare fungal mold infections The foundation is tracking five drugs which include gepotidacin, a small molecule commercialized by GSK with a leading phase 3 program in urinary tract infections and F2G’s olorofim, a first of the new orotomide class of antifungals in development for the treatment of difficult-to-treat invasive, rare fungal mold infections. Innoviva’s zoliflodacin is another treatment being tracked and is said to be one of the most promising new treatments for gonorrhoeae currently in phase 3 clinical trials. According to a report in Nature Scientific Reports, studies have found very little resistance to the drug currently circulating in strains, and in-vitro experiments demonstrated that it is difficult to induce resistance. Venatorx’s cefepime-taniborbactam is also under the foundation’s radar. The beta-lactam/beta-lactamase inhibitor (BL/BLI) combination antibiotic is being developed for the treatment of complicated urinary tract infections and hospital acquired bacterial pneumonia. googletag.cmd.push(function () { googletag.display('text-ad1'); }); Pfizer's recently approved aztreonam-avibactam (Emblaveo) is the first β-lactam/β-lactamase inhibitor antibiotic combination approved in the European Union for treating serious infections in adult patients caused by multidrug-resistant gram-negative bacteria, including metallo-β-lactamase-producing bacteria. Emblaveo was reviewed under European Medicines Agency accelerated assessment procedure, used when a pharmaceutical product is of major interest for public health and therapeutic innovation. People living on the frontlines of drug resistance Collectively, these projects could save at least 160,000 lives annually by providing much-needed medicines to treat drug-resistant gonorrhoea, urinary tract infections, intra-abdominal infections, respiratory infections, and invasive fungal infections. While these diseases affect a wide range of patients globally, women and children- especially those living in low-and middle-income countries (LMICs)- are disproportionately affected. Jayasree Iyer, CEO, at the Access to Medicine Foundation, said: “We have a small, but effective, arsenal in the race to combat drug-resistant infections. The difference between us winning or losing this race depends on how companies enable access to people living on the frontlines of drug resistance.” The foundation said that findings reveal that companies are employing diverse range of strategies within their access and stewardship plans but structured advance planning has not yet become standard. Encouragingly, it said, four of the five companies in scope, GSK, Pfizer, Innoviva, and Venatorx, are conducting or initiating clinical trials that directly target children, signalling progress in closing the gap between adult and paediatric access. Tackling the sheer scale and pace of drug resistance Commitments for registration were identified in five LMICs: China, India, Mexico, South Africa, and Thailand. However, for 108 of 113 LMICs in scope, where people also face high burdens of the diseases targeted by these projects, it is currently unclear whether any of them will be made available upon initial approval. The report identifies opportunities and recommendations for companies in focus and outlines actionable steps for global stakeholders in antimicrobial R&D to promote widespread adoption of advance access and stewardship planning. Marijn Verhoef, director of operations and research, at the Access to Medicine Foundation, said: “Tackling the sheer scale and pace of drug resistance is a complex global health issue that will require action from pharmaceutical companies across several areas. This includes providing appropriate access and implementing stewardship measures to safeguard the effectiveness of innovative antimicrobials. Failure to do this will limit efforts to tackle drug resistance.” The foundation added that as global health stakeholders prepare for 2024 UN General Assembly's High-level Meeting on AMR, this report comes at a crucial moment, emphasising the urgent gaps that need attention.

Phase 3Drug Approval

16 May 2024

·www.biospace.com

Venatorx Pharmaceuticals Announces Changes to Executive Leadership

MALVERN, Pa.--(BUSINESS WIRE)-- Venatorx Pharmaceuticals, a private, pre-commercial pharmaceutical company focused on improving health outcomes for patients with multidrug-resistant bacterial infections and hard-to-treat viral infections, announced today several changes to its executive leadership team. Manos Perros, PhD, has been appointed to the Board of Directors as Executive Chairman. Dr. Perros is a distinguished pharmaceutical and biotech executive with an impressive track record that includes more than 25 years in life sciences research and development. He was previously Chief Executive Officer and co-founder of Entasis Therapeutics, where he successfully positioned the company as a leader in the antimicrobial space, resulting in its acquisition by Innoviva in 2022. While at Entasis, Dr. Perros oversaw the development of Xacduro, which recently earned U.S. Food and Drug Administration approval as the first targeted treatment for Acinetobacter baumannii pneumonia. Prior to founding Entasis, Dr. Perros held the positions of Vice President and Head of AstraZeneca’s Infection Research and Early Development organization and Site Head for AstraZeneca’s Boston R&D research center. Dr. Perros also served as Director of the Novartis Institute for Tropical Diseases in Singapore, and Vice-President and Chief Scientific Officer, Antivirals, at Pfizer, where he led an R&D program that culminated in the approval of Selzentry, a first-in-class treatment for HIV. Dr. Perros’ appointment follows the resignation of Christopher J. Burns, Ph.D., who has stepped down as Chief Executive Officer and Director of Venatorx Pharmaceuticals. Additionally, Tomas J. Heyman has stepped down as Non-Executive Chairman of the Board. “On behalf of the entire Company, I would like to personally thank Chris for his dedication and tireless perseverance to lead Venatorx for over 14 years as an innovative pioneer in the fight against anti-microbial resistance. The Board of Directors sincerely appreciates his contributions along with the endless support and leadership that have guided the Company toward achieving its mission. I am delighted to join Venatorx Pharmaceuticals and to have an opportunity to help advance cefepime-taniborbactam through regulatory review and toward FDA approval to address the growing unmet need for novel treatments for patients suffering from multi-drug resistant gram-negative bacterial infections,” Dr. Perros said. “As recent Phase III data in The New England Journal of Medicine established, cefepime-taniborbactam met the primary noninferiority efficacy endpoint and demonstrated statistical superiority to meropenem for the treatment of complicated urinary tract infections (cUTIs), including acute pyelonephritis, while having a similar safety pro meropenem. This therapy has enormous potential and may represent a significant improvement over the standard of care that could support global health efforts to combat antibiotic-resistant infections for patients around the world.” About Venatorx Pharmaceuticals, Inc. Venatorx is a private, late-stage clinical pharmaceutical company focused on improving health outcomes for patients with multidrug-resistant bacterial infections and hard-to-treat viral infections. Venatorx’s lead program, cefepime-taniborbactam, is a clinical-stage antibiotic that successfully completed a Phase 3 study in adults with complicated urinary tract infections (cUTI), including pyelonephritis. In October 2022, BARDA awarded a contract of up to $318M for development and procurement of cefepime-taniborbactam for the treatment of melioidosis and multi-drug resistant infections. Venatorx is also developing an oral antibacterial, ceftibuten-ledaborbactam (formerly known as VNRX-7145), for the treatment of cUTI, including pyelonephritis, caused by certain bacteria in adult patients with limited treatment options; this product is completing Phase 1 and will advance directly to a global Phase 3 cUTI clinical trial. For more information about Venatorx and its anti-infectives portfolio, please visit . Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the potential, safety, efficacy, and regulatory and clinical development of Venatorx Pharmaceuticals’ product candidates.

Phase 3Executive ChangeDrug ApprovalAcquisitionClinical Result

100 Deals associated with Cefepime Hydrochloride/Taniborbactam

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Complicated urinary tract infection	NDA/BLA	CN	Yunding Xinyao Pharmaceutical Technology Co., Ltd.	-
Pyelonephritis	Phase 2	US	Venatorx Pharmaceuticals, Inc.	15 Aug 2023
Acute pyelonephritis	Preclinical	LV	Everid Medicines (Beijing) Limited	07 Aug 2019
Acute pyelonephritis	Preclinical	BR	Everid Medicines (Beijing) Limited	07 Aug 2019
Acute pyelonephritis	Preclinical	US	Venatorx Pharmaceuticals, Inc.	07 Aug 2019
Acute pyelonephritis	Preclinical	HU	Everid Medicines (Beijing) Limited	07 Aug 2019
Acute pyelonephritis	Discovery	UA	Everid Medicines (Beijing) Limited	07 Aug 2019
Acute pyelonephritis	Discovery	PE	Venatorx Pharmaceuticals, Inc.	07 Aug 2019
Acute pyelonephritis	Discovery	UA	Venatorx Pharmaceuticals, Inc.	07 Aug 2019
Acute pyelonephritis	Discovery	RU	Everid Medicines (Beijing) Limited	07 Aug 2019

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03840148 (CERTAIN-1, CTgov)	Phase 3	Urinary Tract Infections \| Acute pyelonephritis \| Complicated urinary tract infection	661	Cefepime/VNRX-5133 (taniborbactam) (Cefepime/VNRX-5133 (Taniborbactam))	roztkwpluo(eifhqjushl) = ulapppibsb lvxibrjjml (vvuqkglkll, upbrkmctzp - zsfajrerln) View more	-	29 May 2024
				Meropenem (Meropenem)	roztkwpluo(eifhqjushl) = bctemwvjrf lvxibrjjml (vvuqkglkll, xninivgeds - zveytonzhh) View more
NCT03840148 (CERTAIN-1, Pubmed \| Br Dent J \| N Engl J Med) Manual	Phase 3	Urinary Tract Infections	436	Cefepime/taniborbactam	fflwvneqyo(cwujvyylah) = apiiopstuk vuuzbudckj (awtfeqqtym ) View more	Positive	15 Feb 2024
NCT03840148 (CERTAIN-1, Corporate Publications) Manual	Phase 3	Complicated urinary tract infection	661	Cefepime/Taniborbactam	(wkxaxoyoaf) = dxagarmawd sudvykyvww (ktksdsshqv ) View more	Superior	10 Mar 2022
				meropenem	(wkxaxoyoaf) = diificvxxp sudvykyvww (ktksdsshqv ) View more

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