CAMBRIDGE -
Analysis of preliminary, blinded data from the Phase 1 double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial in healthy adult volunteers suggests that SPR206 is well-tolerated at doses that are likely to be within a therapeutic range for target MDR Gram-negative bacterial infections and has a safety profile that Spero believes supports the further development of SPR206. The decision to continue development of SPR206 is also supported by data from nonclinical studies in which SPR206 demonstrated activity as a single agent against MDR and extensively drug resistant (XDR) bacterial strains, including isolates of Pseudomonas aeruginosa, Acinetobacter baumannii and carbapenem-resistant Enterobacteriaceae, in both in vitro and in vivo models of infection.
'We are encouraged by the preliminary safety, tolerability and pharmacokinetic data collected for SPR206 in healthy volunteers and look forward to continuing the development of this novel compound in conjunction with our partners,' said
The Phase 1 clinical trial of SPR206 (Study SPR206-101) evaluated the safety, tolerability and pharmacokinetics of intravenously administered SPR206 at single doses ranging from 10 mg to 400 mg in seven SAD cohorts and repeat total daily doses ranging from 75 mg to 450 mg for seven consecutive days and 300 mg for 14 consecutive days across five MAD cohorts. A total of 96 healthy volunteers were randomized to receive SPR206 or placebo. All reported adverse events were mild to moderate and there were no reported severe or serious adverse events. No evidence of nephrotoxicity was observed and there were no subjects with clinically significant changes in laboratory tests during the study. Although the data remain blinded, an analysis of preliminary data indicates that SPR206 was well-tolerated at doses up to 100 mg administered three-times a day, a total of 300 mg daily, for 14 consecutive days. Preliminary analyses of pharmacokinetic data across the cohorts indicates dose linearity and dose proportionality as well as mean plasma drug exposures of SPR206 that are concordant with preclinical models predictive for clinical efficacy against target Gram-negative pathogens.
Spero expects to receive a development milestone payment from its partner Everest Medicines upon delivery of the SPR206-101 SAD/MAD clinical study report (CSR) as specified under the regional collaboration launched in 2019 and expects to present final data from the Phase 1 clinical trial in the first half of 2020. In conjunction with Everest Medicines, and through its grant from the
About SPR206
SPR206 is designed to treat Gram-negative bacterial infections through the molecule's interactions with the bacterium's outer membrane. SPR206 is a direct acting IV-administered agent that has demonstrated potent broad-spectrum activity against Gram-negative bacteria, including organisms identified by the
SPR206 Research Support
Clinical research for the SPR206 program is funded by The
Non-clinical research for the SPR206 program is funded in part with Federal funds from the
Non-clinical research for the SPR206 program was funded in part by The
About Spero
Spero's lead product candidate, Tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994), is designed to be the first oral carbapenem-class antibiotic for use in adults to treat MDR Gram-negative infections.
Spero is also advancing SPR720, its novel oral therapy product candidate designed for the treatment of rare, orphan disease caused by pulmonary non-tuberculous mycobacterial (NTM) infections.
Spero also has a platform technology known as its Potentiator Platform that it believes will enable it to develop drugs that will expand the spectrum and potency of existing antibiotics, including formerly inactive antibiotics, against Gram-negative bacteria. Spero's potentiator product candidate, SPR206, is designed to treat MDR Gram-negative infections in the hospital setting.
Forward Looking Statements
This press release may contain forward-looking statements. These statements include, but are not limited to, statements about Spero's expectation that positive results from a single pivotal Phase 3 clinical trial of Tebipenem HBr and ancillary supportive studies to be conducted in parallel with the Phase 3 trial will support the approval of Tebipenem HBr; the design, initiation, timing, progress and results of Spero's preclinical studies and clinical trials and its research and development programs, including the timing of Spero's regulatory meeting with the FDA regarding SPR720, the timing of Spero's IND submission with the FDA regarding SPR720, the commencement of Spero's planned Phase 2a clinical trial of SPR720 and the commencement of Spero's planned Phase 1 bronchoalveolar lavage (BAL) clinical trial assessing the penetration of SPR206 into the pulmonary compartment; management's assessment of the results of such preclinical studies and clinical trials; the timing of clinical data, including the availability of pharmacokinetic data from the lead-in cohort in the Phase 3 clinical trial of Tebipenem HBr, final data from the Phase 1 clinical trial of SPR720 and final data from the Phase 1 clinical trial of SPR206 and Spero's cash forecast and anticipated expenses, anticipated payments under Spero's agreement with Everest Medicines, the sufficiency of its cash resources and the availability of additional non-dilutive funding from governmental agencies beyond any initially funded awards. In some cases, forward-looking statements can be identified by terms such as 'may,' 'will,' 'should,' 'expect,' 'plan,' 'aim,' 'anticipate,' 'could,' 'intent,' 'target,' 'project,' 'contemplate,' 'believe,' 'estimate,' 'predict,' 'potential' or 'continue' or the negative of these terms or other similar expressions. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether the FDA will accept a single pivotal study for approval of Tebipenem HBr; whether results obtained in preclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether Spero's product candidates will advance through the preclinical development and clinical trial process on a timely basis, or at all, taking into account the effects of possible regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, clinical trial design and clinical outcomes; whether the results of such trials will warrant submission for approval from the
Contact:
Tel: 857-242-1547
Email: IR@sperotherapeutics.com
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