A Phase 1, Open-label, Single-dose Study to Determine the Safety and Pharmacokinetics of ORAvance (Ceftibuten/Xeruborbactam Oral Prodrug [QPX7831]) in Participants With Renal Impairment

A Phase 1, open-label, single-dose study to determine the safety and pharmacokinetics of ORAvance (ceftibuten/xeruborbactam oral prodrug [QPX7831]) in participants with renal impairment

Start Date01 Jun 2024

Sponsor / Collaborator

Qpex Biopharma, Inc.Startup

[+2]

NCT06079775 / RecruitingPhase 1

A Phase 1, Open-Label, Drug-drug Interaction, and Randomized, Double-blind, Controlled, Multiple-dose Pharmacokinetics and Safety Study of Xeruborbactam Oral Prodrug (QPX7831) in Combination With Ceftibuten in Healthy Adult Participants

Start Date30 Jan 2024

Sponsor / Collaborator

Qpex Biopharma, Inc.Startup

[+2]

NCT05488678 / CompletedPhase 1

VNRX-7145-103: A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Ceftibuten/VNRX-7145 in Participants With Varying Degrees of Renal Function

This is an open-label, multicenter, parallel-group study in participants with normal renal function, mild, moderate, or severe renal impairment, or end stage renal disease (ESRD) undergoing standard intermittent dialysis. The pharmacokinetics (PK) of the inactive prodrug VNRX-7145, its active parent drug VNRX-5236, and ceftibuten will be evaluated after a single oral dose of ceftibuten/VNRX-7145.

Start Date12 Oct 2022

Sponsor / Collaborator

Venatorx Pharmaceuticals, Inc.

[+1]

100 Clinical Results associated with Ceftibuten Dihydrate

100 Translational Medicine associated with Ceftibuten Dihydrate

100 Patents (Medical) associated with Ceftibuten Dihydrate

709

Literatures (Medical) associated with Ceftibuten Dihydrate

10 Jan 2024·Antimicrobial agents and chemotherapy

A phase I, randomized, double-blind, placebo-controlled, ascending single- and multiple-dose study of the pharmacokinetics, safety, and tolerability of oral ceftibuten in healthy adult subjects

Article

Author: Morgan, Elizabeth E ; Loutit, Jeffery S ; Dudley, Michael N ; Roberts, Jason A ; Wallis, Steven C ; Griffith, David C ; Hernández-Mitre, María Patricia

ABSTRACT:

This was a phase I, randomized, double-blind, placebo-controlled, ascending single- and multiple-dose study of oral ceftibuten to describe the pharmacokinetics (PK) of cis- ceftibuten (administered form) and trans- ceftibuten (metabolite), and to describe safety and tolerability at higher than licensed doses. Subjects received single 400, 600, or 800 mg doses of ceftibuten on Days 1 and 4, followed by 7 days of twice-daily dosing from Days 4 to 10. Non-compartmental methods were used to describe parent drug and metabolite PK in plasma and urine. Dose proportionality was examined using Cmax , AUC 0–12 , and AUC 0–INF . Accumulation was calculated as the ratio of AUC 0–12 on Days 4 and 10. Adverse events (AEs) were monitored throughout the study. Following single ascending doses, mean cis - and trans- ceftibuten Cmax were 17.6, 24.1, and 28.1 mg/L, and 1.1, 1.5, and 2.2 mg/L, respectively; cis -ceftibuten urinary recovery accounted for 64.3%–86.9% of the administered dose over 48 h. Following multiple ascending doses, mean cis - and trans- ceftibuten Cmax were 21.7, 28.1, and 38.8 mg/L, and 1.4, 1.9, and 2.8 mg/L, respectively; cis -ceftibuten urinary recovery accounted for 72.2%–96.4% of the administered dose at steady state. The exposure of cis- and trans- ceftibuten increased proportionally with increasing doses. Cis - and trans- ceftibuten accumulation factor was 1.14–1.19 and 1.28–1.32. The most common gastrointestinal treatment emergent AEs were mild and resolved without intervention. Ceftibuten was well tolerated. Dose proportionality and accumulation of cis - and trans -ceftibuten were observed. These results support the ongoing development of ceftibuten at doses up to 800 mg twice-daily. (The study was registered at ClinicalTrials.gov under the identifier NCT03939429.)

01 Jan 2024·Ecotoxicology and environmental safety

Potential effect dietary supplementation of calcium tetraborate in quails exposed to cadmium: Its impact on productive performance, oxidative stress, cecal microflora, and histopathological changes

Article

Author: Mutlu, Muhsin ; Incili, Canan Akdeniz ; Karabulut, Burak ; Incili, Gokhan Kursad ; Iflazoglu Mutlu, Seda ; Iflazoglu, Sera ; Simsek, Ulku Gulcihan ; Seven, Pinar Tatli ; Cevik, Aydın ; Yilmaz, Aysen

Cadmium (Cd) is a ubiquitous environmental pollutant, and Cd exposure harms human health, agriculture, and animal husbandry. The present study aimed to investigate the potential protective effect of dietary supplementation of calcium tetraborate (CTB) on productive performance, oxidative stress, cecal microflora, and histopathological changes in quail exposed to Cd. A total of one hundred twenty, 6-week-old Japanese quail (four females and two males/replicate) were divided into four groups (30 quails/group): the control group (feeding basic diet), CTB group (basic diet containing 300 mg/kg CaB₄O₇, 22.14% elemental B/kg diet), the Cd group (basic diet containing 100 mg/kg cadmium chloride (CdCl₂) (total Cd content of 92.1 mg/kg)) and the CTB + Cd group (basic diet containing 300 mg/kg CTB and 100 mg/kg CdCl₂). The results showed that Cd exposure caused decreased performance, increased the proportion of broken and soft-shelled eggs, induced oxidative stress, affected cecal microflora, epicardial hemorrhages in the heart, focal necrosis in the liver, degeneration in the kidneys, and degenerated and necrotic seminiferous tubules in the testicles. CTB prevented Cd-induced oxidative stress in liver tissue by increasing total antioxidant status and reducing total oxidant status. In addition, CTB improved egg production and feed conversion ratio (FCR). CTB protected the cecal microflora by inhibiting Enterobacteriaceae and promoting Lactobacillus. CTB also reduced Cd-induced histopathological damage in the heart, liver, kidneys, and testicles. In conclusion, these findings suggest that CTB could be used in Cd-challenged quail, and this compound provides new insights into the toxicity of environmental Cd.

01 Jan 2024·The Science of the total environment

Recycling waste tyre polymer for production of fibre reinforced cemented tailings backfill in green mining

Article

Author: Qiu, Jingping ; Zhou, Hao ; Guo, Zhenbang ; Liu, Chen ; Yang, Lei ; Kirichek, Alex

The increasing amount of solid waste, e.g., waste tyres from car industry and tailings from mine operations, causes substantial environmental and societal issues. The recycled tyre polymer fibre (RTPF) reinforced cemented tailings backfill (CTB) is a kind of composite that can treat waste tyres and tailings simultaneously and realize green mining, but its engineering properties have not been well understood. In this study, the rheology (i.e., static and dynamic yield stress, and structural build-up), strength (i.e., uniaxial and triaxial compressive, splitting tensile and flexural strengths), microstructure, and life cycle of RTPF reinforced CTB are comprehensively evaluated. For comparison, the engineering performance of the commonly used polypropylene fibre (PPF) reinforced CTB in mines is tested. The experimental results demonstrate that incorporating 0.6 wt% RTPF into CTB can achieve comparable fluidity and strength to the CTB reinforced with 0.3 wt% PPF at reduced cost and improved sustainability. A strength enhancement approach for RTPF reinforced CTB is also developed by adjusting the viscosity of suspending CTB before the addition of RTPF. With this approach, the splitting tensile strength increases by 68 %. The results obtained from this study pave the way for promoting the recycling of abandoned waste tyres and the safe design of backfill structures in mines.

News (Medical) associated with Ceftibuten Dihydrate

30 May 2024

·www.biospace.com

Qpex Biopharma, a Shionogi Group Company, Receives an Additional $10M Award by BARDA as Part of Qpex’s Partnership to Advance its Portfolio of Antibiotics Addressing Drug-Resistant Infections

SAN DIEGO--(BUSINESS WIRE)-- QPex Biopharma, Inc., a Shionogi Group Company, (hereafter “Qpex”) today announced the exercise of a $10 million option from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response at the U.S. Department of Health and Human Services, to support the advancement of the company’s antibiotic clinical development program. The option was awarded under the company’s existing contract with BARDA that provides up to $132 million in support to advance development of the portfolio of new therapies. “This award follows the important progress made in our programs since our merger with Shionogi last year,” said Michael N. Dudley, Pharm.D., President and CEO of Qpex. “We are grateful for the opportunity to build on our longstanding partnership with BARDA and to continue making progress on our development program as part of a leading global organization with a strong record discovering, developing and commercializing innovative anti-infective products.” The BARDA award will be used to advance xeruborbactam, an investigational beta-lactamase inhibitor, including supporting clinical studies in both IV and oral combinations for infections caused by drug-resistant gram-negative bacteria. “The urgent, global threat of antimicrobial resistance demands innovation,” said John Keller, Ph.D., Senior Executive Officer, Senior Vice President, R&D Supervisory Unit at Shionogi. “Antibiotic drug development is not keeping pace with resistance. Between Qpex’s promising pipeline and Shionogi’s decades of successful infectious disease R&D, our work has the potential to accelerate critically needed solutions for treating drug-resistant infections worldwide.” According to the Centers for Disease Control (CDC), more than 2.8 million antibiotic-resistant infections arise annually in the U.S.1 Among the most severe and difficult-to-treat infections are caused by drug-resistant gram-negative bacteria, several of which are targeted by the Qpex portfolio. Qpex was acquired by Shionogi Inc., a U.S. subsidiary of Shionogi & Co., Ltd., in 2023, bringing together world-class leadership teams and bolstering existing research capabilities and expertise that strengthen Shionogi’s longstanding global efforts to develop critically needed antimicrobials. The Qpex senior leadership team worked together for more than a quarter century, and they have completed four regulatory approvals in the past decade. The Qpex team continues to make progress, having advanced three products to U.S. investigational new drug (IND) application during the company’s first three years of operations. About Qpex 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 are based on xeruborbactam, an investigational ultra-broad-spectrum beta-lactamase inhibitor discovered by Qpex scientists. For more information, please visit and follow us on Twitter and LinkedIn. About Qpex and BARDA Partnership Qpex scientists and clinicians have an extensive track-record of successfully working in public-private partnerships, including a partnership with BARDA that led to the first approved antibiotic drug product under BARDA’s Broad Spectrum development programs in 2017. Qpex’s current partnership with BARDA is advancing xeruborbactam-based products S-649228 (cefiderocol + xeruborbactam IV) and S-743229 (ceftibuten oral + xeruborbactam oral prodrug). The development of these products in Qpex’s portfolio is funded in whole or in part with federal funds from the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, BARDA, under OTA number HHSO100201600026C. To date, BARDA has awarded $92 million and provided technical support. If all options are awarded, the agreement would provide up to $132 million in support for the development of a portfolio of new antibiotics to fight drug-resistant gram-negative infections. 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. References CDC. Antibiotic Resistance Threats in the United States, 2019. Atlanta, GA: U.S. Department of Health and Human Services, CDC; 2019.

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

12 Mar 2024

·www.biospace.com

Venatorx Pharmaceuticals Expands Senior Leadership Team

Key Hires in CMC/Technical Operations, Business Development, and Finance 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 expansion of its leadership team with three key industry veterans: Jason Burdette joining as Senior Vice President, CMC and Technical Operations: Armand Girard as Chief Business Officer; and Tamra Adams, and Chief Financial Officer. These appointments come as the Company expands its remit from pure R&D to encompass support of commercialization. "Jason, Armand and Tamra bring a breadth of experience that will be instrumental to Venatorx as we continue to advance our portfolio and maximize the value of our assets," said Christopher J. Burns, Ph.D., President and CEO of Venatorx. "These additions to our senior leadership team are critical to ensure we are prepared for our NDA resubmission and are strategically positioned for continued success." Jason Burdette – Senior Vice President, CMC and Technical Operations – Burdette started at Venatorx in late 2023 and is an experienced leader with more than 30 years in the pharmaceutical industry across process chemistry, formulation and process development, manufacturing, supply chain management, and technical operations. He joined Venatorx from Aimmune/Nestle Health Science where he was a Senior Vice President and Head of Technical Operations. At Aimmune/Nestle Health Science, Burdette was responsible for formulation and process development, analytical development, CMC, manufacturing science and technology, quality control, quality assurance, supply chain, and product distribution. Before this, he was the Senior Vice President of Technical Operations with Paratek Pharmaceuticals and over the years has worked at Eagle Pharmaceuticals, Shire with aaiPharma, Elan Pharmaceuticals, Sandoz, and Mylan Pharmaceuticals. Burdette earned a bachelor's degree in chemistry and an MBA from West Virginia University. Armand Girard – Chief Business Officer – Girard is a seasoned biopharmaceutical executive with multiple product approvals and launches over his 25 years of experience in strategic planning, corporate development, clinical development, and business development. He has extensive partnering experience having completed collaborations, licenses, acquisitions, and spinouts by and between leading pharmaceutical and biotech companies. Girard joined Venatorx from GlycoMimetics where he was the Chief Business Officer. At GlycoMimetics, he was responsible for corporate strategy, partnering, and managing the company's corporate and institutional alliances supporting the development of uproleselan. Previously, he was Vice President, Technical Assessment and Senior Director for Business Development at Shire Pharmaceuticals to build the product pipeline and support Shire's strategic venture arm through investments. He received his undergraduate degree from Lehigh University and an MBA from St Joseph's Haub School of Business Executive Pharmaceutical Marketing Program. Tamra Adams – Chief Financial Officer – Adams has over 25 years of financial management experience. Most recently, she was CFO at Antios Therapeutics, a clinical-stage biopharmaceutical company that was developing innovative therapies to treat and cure HBV. Adams helped lead a $107 million financing and was responsible for IPO readiness, including filing the S-1. Before joining Antios, she founded Accounting Concepts, Inc., a firm that provided CFO, accounting, and financial services to emerging growth companies in the biopharmaceutical and information technology industries. Before that, Adams was the Senior Financial Executive at Silverstorm Technologies and began her career at Ernst & Young, followed by Goldman Sachs. She received her undergraduate degree from the State University of New York at Albany and received her CPA license in New York State. 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.

Executive ChangePhase 3Phase 1

100 Deals associated with Ceftibuten Dihydrate

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KEGG	Wiki	ATC	Drug Bank
-	Ceftibuten Dihydrate	J01DD14	DB01415

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Acute sinusitis	CN	Schering-Plough SpA	16 Jun 2000
Bronchitis	CN	Schering-Plough SpA	16 Jun 2000
Neisseriaceae Infections	CN	Schering-Plough SpA	16 Jun 2000
Urinary Tract Infections	CN	Schering-Plough SpA	16 Jun 2000
Respiratory Tract Infections	JP	-	14 Oct 1996
Otorhinolaryngologic Diseases	JP	-	09 Oct 1996
Bacterial Infections	US	NC Pharmaceuticals LLC	20 Dec 1995
Bronchitis, Chronic	US	NC Pharmaceuticals LLC	20 Dec 1995
Otitis Media	US	NC Pharmaceuticals LLC	20 Dec 1995
Tonsillitis	US	NC Pharmaceuticals LLC	20 Dec 1995
Gram-Negative Bacterial Infections	JP	Pernix Group, Inc.	01 Jan 1992
Gram-Positive Bacterial Infections	JP	Pernix Group, Inc.	01 Jan 1992

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