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Spero Therapeutics Announces Third Quarter 2018 Financial Results and Pipeline Overview

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Pipeline rapidly advancing with three clinical trials planned to initiate by early 2019, including a SPR994 Phase 3 initiation around year-end 2018 CAMBRIDGE, Mass.,

November 8, 2018 Spero Therapeutics, Inc. (Nasdaq:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multi-drug resistant (MDR) bacterial infections, today announced financial results for the third quarter ended September 30, 2018 and provided a pipeline overview. We continue to make significant progress across all of our product candidates, said Ankit Mahadevia, M.D., Chief Executive Officer of Spero Therapeutics. Positive news on all of our product candidates within the past six months, coupled with our recent follow-on offering and non-dilutive funding award from BARDA, puts us in a strong position to execute on our clinical plan and further our mission of developing new treatments to address the critical unmet need of drug-resistant infections. We look forward to starting the Phase 3 SPR994 trial and Phase 1 SPR206 trial around year-end 2018 followed by the Phase 1 SPR720 trial in early 2019. Recent Clinical Highlights and Upcoming Milestones SPR994: The Companys lead product candidate, SPR994, is designed to be the first broad-spectrum oral carbapenem-class antibiotic for use in adults to treat MDR Gram-negative infections. In September 2018, Spero announced positive results from a final analysis of its single ascending dose (SAD) and multiple ascending dose (MAD) Phase 1 clinical trial of SPR994. Data demonstrated that repeat dose administration of both 300 mg and 600 mg of SPR994 was well tolerated, with a safety profile consistent with the carbapenem class of antibiotics. Final results demonstrated a linear and proportional increase in plasma exposure over the dose range tested, with peak urine concentrations approximately 50 to 100-fold higher than the maximum concentrations in plasma, supporting SPR994s potential utility as treatment for patients with complicated urinary tract infection (cUTI). Spero believes the data support the advancement of SPR994 at a dose of 600 mg administered three times per day (TID) into a pivotal Phase 3 clinical trial in cUTI. Following a scheduled pre-Phase 3 meeting with the U.S. Food and Drug Administration in the fourth quarter of 2018, Spero expects to submit an investigational new drug application (IND) and initiate a pivotal Phase 3 clinical trial of SPR994 for the treatment of cUTI around year-end 2018. To support clinical development of SPR994, in July 2018 the Biomedical Advanced Research and Development Authority (BARDA) and the …

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Source: US SEC
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EX-991_of_8-K_for_Spero_Therapeutics_Inc__8-K-11-08-2018