Benzinga | Jun 15, 2021 04:02PM EDT

Spero Therapeutics Announces Initiation Of Bronchoalveolar Lavage And Renal Impairment Clinical Trials Of SPR206

Spero Therapeutics, Inc. (NASDAQ:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing, and commercializing treatments in high unmet need areas involving multi-drug resistant bacterial infections and rare diseases, today announced the initiation of two Phase 1 trials of SPR206, an intravenously (IV)-administered next-generation polymyxin product candidate. SPR206 was derived from Spero's potentiator platform and is being developed to treat serious multi-drug resistant (MDR) Gram-negative infections in the hospital setting. These trials, which are now open for enrollment, include a bronchoalveolar lavage (BAL) clinical trial assessing the penetration of SPR206 into the pulmonary compartment and a renal impairment clinical trial.

"SPR206 has the potential to treat serious infections in patients with limited therapeutic options, and the initiation of these Phase 1 trials represents an important step in its clinical development," said Ankit Mahadevia, M.D., Chief Executive Officer of Spero Therapeutics. "The preclinical and clinical data set supporting SPR206 demonstrates a favorable safety profile and potent activity against MDR and extensively drug resistant bacterial strains. We expect these newly initiated trials to build on prior results by providing crucial pharmacokinetic (PK) data. These PK data will inform the potential utility of SPR206 in specific tissue compartments and the design of future efficacy trials that will seek to address the urgent threat posed by MDR Gram-negative infections."

The Phase 1 BAL clinical trial is an open-label study designed to enroll thirty healthy volunteers into five cohorts. Subjects will receive three 100 mg doses of SPR206 infused every eight hours over one day. The objectives of the study are to evaluate the intrapulmonary PK, including epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations of SPR206 compared to plasma concentrations. These data are important to establish dose requirements for clinical efficacy of SPR206 in the setting of hospital-acquired pneumonia (HAP)/ventilator-associated pneumonia (VAP). This study is being conducted in collaboration with, and with financial support from, the United States Department of Defense (Award No. W81XWH1910295). The initiation of this clinical trial triggers the first of two milestone payments related to the study from Spero's development partner, Everest Medicines.

The Phase 1 renal impairment clinical trial is an open-label study designed to enroll forty subjects into five cohorts. Cohort 1 will be healthy volunteers, cohorts 2-4 will be clinically stable subjects with various degrees of renal insufficiency, and cohort 5 will be clinically stable subjects with end stage renal disease (ESRD) on hemodialysis. Subjects will receive a single 100 mg infusion of SPR206. The objectives of the study are to evaluate the PK of SPR206 in healthy subjects and in those with various degrees of renal insufficiency, including ESRD. These data are important to establish if the concentrations of SPR206 are impacted by differences in renal function and whether dose adjustments for SPR206 would be recommended in such context. This study is being conducted in collaboration with, and with financial support from, the United States Department of Defense (Award No. W81XWH1910295).

Data from a prior Phase 1 clinical trial showed that SPR206 was generally well tolerated with a lack of nephrotoxicity at predicted therapeutic dose levels. Results from the Phase 1 BAL and renal impairment clinical trials are expected by early 2022.