MedPath

Imipenem

Generic Name
Imipenem
Brand Names
Primaxin, Recarbrio
Drug Type
Small Molecule
Chemical Formula
C12H17N3O4S
CAS Number
64221-86-9
Unique Ingredient Identifier
Q20IM7HE75
Background

Imipenem is a semisynthetic thienamycin that has a wide spectrum of antibacterial activity against gram-negative and gram-positive aerobic and anaerobic bacteria, including many multiresistant strains. It is stable to many beta-lactamases. Similar compounds include meropenem, known for having greater activity against Gram negative bacteria, and the newer ertapenem which exhibits a longer half-life due to increased binding to plasma proteins. Imipenem is commonly used in combination with cilastatin and is now available in a triple-drug product with cilastatin and relebactam which was recently approved by the FDA. Imipenem was first approved by the FDA in November 1985 as the combination product Primaxin marketed by Merck & Co.

Indication

Imipenem is indicated, in combination with cilastatin with or without relebactam, for the treatment of bacterial infections including respiratory, skin, bone, gynecologic, urinary tract, and intra-abdominal as well as septicemia and endocarditis.

Associated Conditions
Bacterial Septicemia, Bone and Joint Infections, Complicated Intra-Abdominal Infections (cIAIs) caused by Gram-negative Bacteria, Complicated Urinary Tract Infection, Complicated Urinary Tract Infection caused by Gram-negative Bacteria, Endocarditis caused by staphylococcus aureus, Gynecological Infection, Intraabdominal Infections, Lower respiratory tract infection bacterial, Nosocomial Pneumonia caused by Gram-negative Bacteria, Pyelonephritis, Skin and Subcutaneous Tissue Bacterial Infections, Uncomplicated Urinary Tract Infections, Ventilator Associated Bacterial Pneumonia caused by Gram-negative Bacteria

Arch Biopartners Advances AKI Programs: LSALT Peptide and Cilastatin Trials Progress

• Arch Biopartners' Phase II trial of LSALT peptide for cardiac surgery-associated acute kidney injury (CS-AKI) gains ethics approval in Ontario, with patient recruitment set to begin in Toronto. • A 700-patient Phase II trial (PONTiAK) evaluating cilastatin for preventing drug-induced AKI receives a No Objection Letter from Health Canada, paving the way for the trial to proceed. • Both LSALT peptide and cilastatin target the dipeptidase-1 (DPEP1) pathway, addressing significant unmet needs in preventing and treating AKI caused by inflammation or toxins. • These advancements highlight Arch Biopartners' commitment to developing innovative therapies for acute kidney injury and organ damage, with ongoing trials in Canada and internationally.

Spero Therapeutics Halts SPR720 Development After Phase IIa Failure

• Spero Therapeutics discontinued the development of SPR720 after it failed to meet the primary endpoint in a Phase IIa trial for non-tuberculous mycobacterial pulmonary disease (NTM-PD). • The interim analysis of the trial showed no significant antimicrobial effect compared to placebo, leading to the suspension of the SPR720 program. • Spero plans to focus on its other antibiotic programs, including tebipenem HBr and SPR206, while also reducing its workforce by 39% to extend its cash runway. • The company's stock price declined by over 17% following the announcement, reflecting investor concerns about the future of the SPR720 program.

Spero Therapeutics Halts SPR720 Development After Phase 2a Trial Fails to Meet Primary Endpoint

• Spero Therapeutics suspends SPR720 development for NTM-PD after Phase 2a trial fails to demonstrate sufficient separation from placebo in interim analysis. • The Phase 2a trial showed antimicrobial activity but raised safety concerns, including reversible grade 3 hepatotoxicity at the 1,000mg dose. • Spero will restructure operations, reducing workforce by 39% to extend cash runway into mid-2026 and focus on tebipenem HBr and SPR206. • The company remains committed to advancing tebipenem HBr in its Phase 3 trial for cUTI and preparing for a Phase 2 trial for SPR206, pending funding.

FDA Approves Merck's Recarbrio for Complex Infections with Antimicrobial Stewardship Focus

• The FDA has granted approval for Recarbrio, Merck's novel triple-drug antibiotic combining imipenem/cilastatin with relebactam, for treating complicated urinary tract and intra-abdominal infections. • Health authorities emphasize Recarbrio should be reserved as a last-resort treatment option, specifically for cases where limited or no alternative antibacterial drugs are available. • The drug targets resistant gram-negative bacteria including Pseudomonas and Klebsiella species, with relebactam designed to overcome carbapenem resistance mechanisms.

Protection of the Human Gut Microbiome From Antibiotics

A clinical trial demonstrated that DAV132, a product containing activated charcoal, significantly reduces the exposure of the human gut microbiome to the antibiotic moxifloxacin (MXF) without affecting its plasma pharmacokinetics. The study, involving healthy volunteers, showed that DAV132 could protect the intestinal microbiota's richness and composition from the adverse effects of MXF, suggesting its potential to mitigate the long-term consequences of antibiotic treatments.
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