Antabio Announces First Subjects Dosed in Phase 1 Clinical Trial of Highly Differentiated Antibiotic for Severe Hospital Infections
Antabio SAS recently announces dosing of the first subjects in its Phase 1 clinical trial of MEM-ANT3310, a next- generation antibacterial combination that has been designed to make a significant impact on the growing problem of antimicrobial resistance in serious hospital infections.
MEM-ANT3310 combines the well-known carbapenem meropenem (MEM) with ANT3310, a breakthrough serine-beta-lactamase (SBL) inhibitor developed by Antabio. This combination has been designed to provide a unique coverage of priority Gram-negative pathogens including OXA-carbapenem-resistant Acinetobacter baumannii (CRAB), KPC- and OXA- carbapenem-resistant Enterobacterales (CRE), and Pseudomonas aeruginosa (PA).
ANT3310 represents an important advance as its innovative structure completely inhibits the enzymes that confer resistance and as a result, restores MEM’s activity against these deadly pathogens.
Magdalena Zalacain, Chief Scientific Officer of Antabio, said “MEM-ANT3310 is the culmination of a very creative and focused program aiming to develop a truly differentiated antibiotic active against both CRAB and CRE pathogens. MEM-ANT3310 is a strong addition to the clinical armamentarium to treat severe or life-threatening infections due to Gram-negative pathogens.”
The Phase 1 clinical trial is designed to assess the safety, tolerability, and pharmacokinetic (PK) profile of single and multiple ascending doses (SAD/MAD) of intravenous ANT3310 administered alone, followed by an assessment of the combination of ANT3310 with MEM in healthy volunteers.
Carole Sable, MD, Infectious Disease expert and clinical advisor of Antabio, added “There is a very clear need for safe and effective therapies to treat serious antibiotic-resistant infections in hospitalized patients, including when polymicrobial infections are suspected. Based on the preclinical profile of MEM-ANT3310, I believe it has the potential to provide a valuable broad-spectrum therapeutic option to meet unmet medical needs of this high-risk patient population.”
Marc Lemonnier, CEO of Antabio added, “We are thrilled to reach this important milestone with the start of our first in man study for MEM-ANT3310. We see great promise for patients in this novel antibacterial combination addressing the highest WHO priorities for antibiotic resistance while building on a well-established regulatory path towards approval.”
Initial funding for the development of MEM-ANT3310 of €5.5 million was received in 2022 from the French government through the “ARPEGE” program.
Carbapenems, such as meropenem, are the cornerstone of therapies for many life-threatening infections. Resistance to carbapenems is considered a critical priority by the World Health Organization (WHO) and Centre for Disease Control and Prevention (CDC) because it is a major cause of treatment failure, increased mortality, and huge economic costs. Bacteria resistant to carbapenems produce beta-lactamase enzymes that render antibiotics, such as meropenem (MEM), ineffective.
Antabio has set out to resolve this major healthcare issue via its lead clinical-stage program MEM-ANT3310. Its innovative serine-beta-lactamase inhibitor ANT3310 represents a significant breakthrough as it completely inhibits a broad range of beta-lactamases, including the Klebsiella pneumoniae carbapenemases (KPC) and oxacillin-hydrolyzing (OXA) type enzymes found in Carbapenem-Resistant Enterobacterales (CRE) and Carbapenem-Resistant Acinetobacter baumannii (CRAB), and restores MEM activity against these deadly pathogens. This is critical for the treatment of polymicrobial infections such as those causing hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP).
ANT3310, in combination with the antibiotic meropenem, has received qualified infectious disease product (QIDP) status from the FDA in 2019 for complicated urinary tract infections (cUTI), complicated intra-abdominal infections (cIAI) and hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP).
Antabio is a clinical-stage biopharmaceutical company developing novel and highly differentiated antibacterial treatments of drug-resistant infections as defined by the CDC and WHO’s critical priority pathogens, with a particular focus on life-threatening respiratory infections, including carbapenem-resistant nosocomial pneumonia and chronic pulmonary diseases.
The company’s lead program, MEM-ANT3310, is being developed for the treatment of hospital-acquired infections such as nosocomial pneumonia caused by carbapenem-resistant Acinetobacter baumannii (CRAB) and carbapenem-resistant Enterobacterales (CRE).
Antabio’s portfolio includes two further programs: 1) ANT3273, a groundbreaking, novel class, novel mode of action inhalation treatment of Pseudomonas aeruginosa (PA) infections, particularly those affecting patients with chronic pulmonary diseases (such as Bronchiectasis, Cystic Fibrosis and COPD); and 2) ANT2681, a novel and potent metallo beta-lactamase (MBL) inhibitor to be combined with meropenem for the treatment of MBL-producing carbapenem-resistant Enterobacterales (CRE), particularly New Delhi metallo-beta-lactamase (NDM) carrying strains.
Antabio has built an international team, including former executives from Novexel, Merck, GSK, and AstraZeneca.
The company has an impressive track-record in attracting non-dilutive funding, including multi-million-dollar awards from the Wellcome Trust, CARB-X, and ARPEGE. For more information, visit https://antabio.com/.
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