There has been a significant decrease in the number of novel IV antibiotics in development and approved over the past 40 years for the treatment of Gram-negative infections. The physiology of Gram-negative bacteria – specifically the make-up of the outer-membrane of these bacteria – is one of the primary roadblocks hindering scientific advancement and innovation.
SPR206 is an innovative, investigational IV direct-acting antibiotic that has shown antibiotic activity against MDR Gram-negative pathogens, including carbapenem-resistant Enterobacteriaceae, Acinetobacter baumannii and Pseudomonas aeruginosa in preclinical studies. SPR206 completed non-clinical, IND-enabling studies supporting its advancement as a potential clinical candidate designed to treat MDR and extensively drug-resistant (XDR) bacterial strains. Based on microbiological and in vivo testing, we believe that SPR206 has the potential to offer a broad-spectrum of activity, including against XDR bacterial strains. In January 2020, we announced data from a Phase 1 clinical trial designed as a double-blind, placebo-controlled, ascending dose, multi-cohort study in healthy subjects. Phase 1 clinical data suggested that SPR206 at doses that are likely to be within a therapeutic range for target MDR Gram-negative bacterial infections supports the further development of SPR206. In conjunction with our alliance partners, we plan to conduct a Phase 1 bronchoalveolar lavage (BAL) clinical trial assessing the penetration of SPR206 into the pulmonary compartment in the first half of 2021, as well as initiate a renal impairment study with SPR206.
SPR206 is designed to interact with the LPS to disrupt the outer membrane and is designed to have antibiotic activity as a single agent against MDR and XDR bacterial strains, including carbapenem-resistant Pseudomonas aeruginosa, Acinetobacter baumannii and Enterobacteriaceae.
In our Phase 1 SAD/MAD clinical trial, all reported adverse events were mild to moderate and there were no reported severe or serious adverse events. No evidence of nephrotoxicity was observed.
We have seen in preclinical studies that SPR206 has the potential to offer a broad-spectrum of activity.
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