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Antabio, a private biopharmaceutical company developing novel and highly differentiated antibacterial treatments for critical priority pathogens, with a particular focus on life-threatening respiratory infections, has announced that it has completed the Phase 1 clinical trial for MEM-ANT3310 in healthy volunteers.
Antabio’s MEM-ANT3310 is a next generation broad-spectrum antibacterial combination that has been designed to address the growing problem of antimicrobial resistance in severe hospital infections. MEM-ANT3310 combines the carbapenem meropenem (MEM) with ANT3310, a breakthrough serine-beta-lactamase (SBL) inhibitor that provides 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).
The Phase 1 clinical trial included 72 healthy volunteers across three parts and evaluated the safety, tolerability, and pharmacokinetic (PK) profile of Single and Multiple Ascending Doses (SAD/MAD) of the intravenous beta-lactamase inhibitor ANT3310, administered alone. The potential mutual PK interaction between ANT3310 and meropenem was investigated, followed by an assessment of the combination MEM-ANT3310 during multiple intravenous dosing.
ANT3310 was well-tolerated at all doses with no serious adverse events, dose-limiting toxicities or clinically relevant abnormalities reported. The ANT3310 PK parameters were consistent with those determined from studies in rodent and non-rodent species and dose-dependent increases in exposure were observed. ANT3310 and meropenem demonstrated very compatible PK with no mutual PK interaction.
This positive Phase 1 data supports further patient studies of MEM-ANT3310.
“With matching PK and good tolerability, MEM-ANT3310 shows great promise to address serious infections whenever multidrug resistance is a concern in hospitalised patients,” said Marc Lemonnier, CEO of Antabio. “With a uniquely broad coverage, we believe MEM-ANT3310 will be very well positioned to meet the urgent medical needs in high-risk patients, especially when multidrug-resistant pathogens or polymicrobial infections are suspected."
Antabio is currently conducting a Phase 1 PK study of MEM-ANT3310 in subjects with impaired renal function and is planning a second PK study to assess the distribution of MEM-ANT3310 in the lung (epithelial lining fluid) in healthy volunteers.
