Urinary Tract Infections - Pipeline Insight, 2024

This “Urinary Tract Infections - Pipeline Insight, 2024,” report provides comprehensive insights about 38+ companies and 38+ pipeline drugs in Urinary Tract Infections pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Urinary Tract Infections Understanding

Urinary Tract Infections: Overview

Urinary tract infections (UTIs) are a severe public health problem and are caused by a range of pathogens, but most commonly by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Enterococcus faecalis and Staphylococcus saprophyticus. High recurrence rates and increasing antimicrobial resistance among uropathogens threaten to greatly increase the economic burden of these infections. Clinically, UTIs are categorized as uncomplicated or complicated. Uncomplicated UTIs typically affect individuals who are otherwise healthy and have no structural or neurological urinary tract abnormalities; these infections are differentiated into lower UTIs (cystitis) and upper UTIs (pyelonephritis). Several risk factors are associated with cystitis, including female gender, a prior UTI, sexual activity, vaginal infection, diabetes, obesity and genetic susceptibility. Complicated UTIs are defined as UTIs associated with factors that compromise the urinary tract or host defence, including urinary obstruction, urinary retention caused by neurological disease, immunosuppression, renal failure, renal transplantation, pregnancy and the presence of foreign bodies such as calculi, indwelling catheters or other drainage devices. The treatment has varied historically from 3 days to 6 weeks. There are excellent cure rates with “mini-dose therapy” which involves three days of treatment. The FDA has approved fosfomycin as a single-dose therapy for uncomplicated UTIs caused by E coli. Adjunctive therapy with phenazopyridine for several days may help provide additional symptom relief.

Urinary Tract Infections - Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Urinary Tract Infections pipeline landscape is provided which includes the disease overview and Urinary Tract Infections treatment guidelines. The assessment part of the report embraces, in depth Urinary Tract Infections commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Urinary Tract Infections collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

• In January 2022, Spero Therapeutics announced that the US FDA has accepted for Priority Review the New Drug Application for tebipenem HBr (tebipenem pivoxil hydrobromide) for the treatment of adults with complicated urinary tract infections (c UTI), including pyelonephritis, caused by susceptiblemicroorganisms.
• In May 2022, Evofem Biosciences reported post-hoc analysis data from the Phase III AMPOWER clinical trial where Phexxi (lactic acid, citric acid, and potassium bitartrate) was shown to lower urinary tract infections (UTIs) in women.

Urinary Tract Infections Emerging Drugs Chapters

This segment of the Urinary Tract Infections report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Urinary Tract Infections Emerging Drugs

Tebipenem HBr: Spero Therapeutics Tebipenem HBr is an investigational drug in the United States being developed for the treatment of complicated urinary tract infection, including pyelonephritis, caused by certain microorganisms, in adult patients who have limited oral treatment options. Tebipenem HBr has been granted Qualified Infectious Disease Product (QIDP), Fast Track and Priority Review designations for treatment of complicated urinary tract infection (c UTI), including acute pyelonephritis. The FDA set a Prescription Drug User Fee Act (PDUFA) target action date for June 27, 2022. In March 2022, Spero announced that as part of the FDA’s ongoing review of Spero’s NDA for tebipenem HBr, the FDA had identified deficiencies that precluded the discussion of labeling and post-marketing requirements/commitments at such time. Spero’s LCM with the FDA was in late April2022.

Sulopenem etzadroxil: Iterum Therapeutics Sulopenem is an orally bioavailable, broad-spectrum penem ß-lactam antibiotic which is being developed for the treatment of infections caused by multi-drug resistant bacteria. Sulopenem can, however, be administered orally (e.g as a tablet) or by intravenous (IV) infusion. This makes it an attractive option for the treatment of patients with uncomplicated and complicated urinary tract infections (UTI) and complicated intra-abdominal infections (c IAI) caused by susceptible organisms. The IV formulation is intended for the initial treatment of severe infections in a hospital setting, and the oral prodrug will provide the option for IV-to-oral switch, thereby potentially minimizing in-hospital patient stay. The oral prodrug is also intended for the treatment of uncomplicated infections where a patient can tolerate an oral drug in an outpatient setting. The development approach for sulopenem includes its evaluation for the treatment of u UTI, cUTI and cIAI. Qualified Infectious Disease Product (QIDP) designation was granted by the U.S. FDA for both intravenous and oral formulations in the treatment of complicated urinary tract infections (cUTI), uncomplicated urinary tract infections (uUTI) as well as complicated intra-abdominalinfections(cIAI).

In September 2021, Company held a Type A meeting with the US Food and Drug Administration (FDA) during the third quarter of 2021 to discuss the steps required for potential resubmission of the New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (u UTI). In July 2021, the Company announced that it had received a Complete Response Letter (CRL) from the FDA requesting additional data to support approval of oral sulopenem for the treatment of adult women with a u UTI. Based on the current operating plan and subject to final determination of the design and planned conduct of additional clinical and potential nonclinical development for sulopenem, the Company believes that it is well positioned financially to fund its operations into the second halfof2023.

Gepotidacin: Glaxo SmithKlineGepotidacin (GSK2140944) is the first in a new class of antibiotics, called triazaacenaphthylene topoisomerase inhibitors, developed at GSK in 2007 with a novel “dual targeting” mechanism of action (MOA) and oral formulation. Its MOA is distinct from any currently approved antibiotic. Gepotidacin works by selectively interacting with two key bacterial enzymes, DNA gyrase and topoisomerase IV (type II topoisomerases), responsible for bacterial replication. The novel MOA confers activity against most target pathogens resistant to established antibiotics, including fluoroquinolones. GlaxoSmithKline is conducting a phase III clinical programme investigating gepotidacin, the first in a new chemical class of antibiotics called triazaacenaphthylene bacterial topoisomerase inhibitors, in patients with uncomplicated urinary tract infection (u UTI, also known as acute cystitis) and urogenitalgonorrhoea(GC).

Cefepime-taniborbactam: Venatorx Pharmaceuticals Cefepime-taniborbactam is Venatorx’s beta-lactam / beta-lactamase inhibitor (BL/BLI) combination antibiotic that is being developed for the treatment of complicated urinary tract infections (c UTIs) and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia(HABP/VABP).

Cefepime, a fourth-generation cephalosporin, is a widely used beta-lactam (BL) antibiotic with more than two decades of proven safety and clinical utility against susceptible gram-negative and gram-positive bacteria. Taniborbactam is a beta-lactamase inhibitor (BLI) that, in combination with cefepime, may offer a potential treatment option for patients with serious bacterial infections caused by difficult-to-treat drug resistant gram-negative bacteria, most notably carbapenem-resistant Enterobacterales (CRE) and carbapenem-resistant Pseudomonas aeruginosa (CRPA). Many of these organisms are also multidrug-resistant (MDR), further limiting treatment options. The U.S. Food and Drug Administration (FDA) granted cefepime-taniborbactam Qualified Infectious Disease Product (QIDP) and Fast Track designations for the treatment of c UTI and HABP/VABP. The FDA and the EMA approved Venatorx’s initial Pediatric Study Plan (i PSP) and Pediatric Investigation Plan (PIP), respectively, for cefepime-taniborbactam. In a Phase III clinical trial Cefepime-taniborbactam met the primary efficacy endpoint of statistical noninferiority (NI) to meropenem in the microITT population at TOC with composite microbiologic and clinical success occurring in 70.0% of cefepime-taniborbactam treated patients and 58.0% of meropenem treated patients (treatment difference 11.9; 95% confidence interval (CI),2.4,21.6).

Urinary Tract Infections: Therapeutic Assessment

This segment of the report provides insights about the different Urinary Tract Infections drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Urinary Tract Infections

There are approx. 38+ key companies which are developing the therapies for Urinary Tract Infections. The companies which have their Urinary Tract Infections drug candidates in the most advanced stage, i.e. preregistration include, Spero Therapeutics.

Phases

This report covers around 38+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

Urinary Tract Infections pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Inhalation
• Inhalation/Intravenous/Oral
• Intranasal
• Intravenous
• Intravenous/ Subcutaneous
• NA
• Oral
• Oral/intranasal/subcutaneous
• Parenteral
• Subcutaneous

Molecule Type

Products have been categorized under various Molecule types such as

• Antibody
• Antisense oligonucleotides
• Immunotherapy
• Monoclonal antibody
• Peptides
• Protein
• Recombinant protein
• Small molecule
• Stem Cell
• Vaccine

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Urinary Tract Infections: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Urinary Tract Infections therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Urinary Tract Infections drugs.

Urinary Tract Infections Report Insights

• Urinary Tract Infections Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Urinary Tract Infections Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Urinary Tract Infections drugs?
• How many Urinary Tract Infections drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Urinary Tract Infections?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Urinary Tract Infections therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Urinary Tract Infections and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Wockhardt
• GlaxoSmithKline
• Iterum Therapeutics
• Spero Therapeutics
• VenatoRx Pharmaceuticals
• Helperby Therapeutics
• Spexis
• LUCA Biologics
• Seed Health, Inc.
• Aelin Therapeutics
• Omnix Medical
• Inmunotek S.L.
• Sinovent Pty Ltd.
• Qilu Pharmaceuticals
• Entasis Therapeutics
• Adaptive Phage Therapeutics
• Locus Biosciences
• Nabriva Therapeutics
• Utility Therapeutics
• Zensun (Shanghai) Sci & Tech
• Fedora Pharmaceuticals
• Osel Inc.,
• Evofem Biosciences
• Enlivex
• Fimbrion Therapeutics
• Rebiotix
• Mer LionPharmaceuticals
• Allecra Therapeutics
• Lakewood Amedex
• Sumitomo Dainippon Pharma
• Sihuan Pharmaceuticals
• Super TransMedical
• Asieris Pharmaceuticals

Key Products

• Cefepime-zidebactam
• Gepotidacin
• Sulopenem etzadroxil
• Tebipenem Pivoxil Hydrobromide
• Phexxi
• HY-009B2
• Lactin-V
• Nacubactam
• VMSC-04
• MV140
• ZS05
• VNRX-5133
• XNW4107
• Fosfomycin intravenous
• Pivmecillinam Oral
• etx0282
• GSK3882347
• LBP-EC01
• Meropenem-FL058
• RBX2660
• Finafloxacin
• Cefepime/enmetazobactam
• Nu-8
• Benapenem
• STM001
• APL-1501

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