Spero Therapeutics Announces Positive Topline Results from Phase 1 Bronchoalveolar Lavage Clinical Trial of SPR206, A Novel Intravenous Next Generation Polymyxin Antibiotic for the Treatment of Multi-drug Resistant Gram-Negative Infections in the Hospital Setting

SPR206 shown to be well-tolerated; achieved lung exposures consistent with predicted therapeutic levels, when administered three times daily at 100 mg

Results support further development of SPR206 in the setting of hospital-acquired pneumonia and ventilator-associated pneumonia

Excerpt from the Press Release:

CAMBRIDGE, Mass., Feb. 16, 2022 (GLOBE NEWSWIRE) — Spero Therapeutics, Inc. (Nasdaq: SPRO), today announced topline findings from its Phase 1 bronchoalveolar lavage (BAL) clinical trial of SPR206, an intravenously (IV)-administered next-generation polymyxin product candidate. SPR206 was derived from Spero’s potentiator platform and is in development to treat serious multi-drug resistant (MDR) gram-negative infections in the hospital setting.

The Phase 1 BAL study evaluated the safety and pharmacokinetics (PK) of SPR206 when administered at 100 mg, three times daily. Results showed that SPR206 was generally well-tolerated with a mean lung epithelial lining fluid (ELF) to plasma concentration ratio of 0.264, with area under the curve (AUC) from 0-8 hours used to estimate the total uptake of SPR206. Importantly, the mean concentration of SPR206 in the lung ELF exceeds the SPR206 MIC (minimum inhibitory concentration) for targeted gram-negative pathogens for the entirety of the 8-hour dosing period.

“Many of the patients we hope to serve suffer from extensive drug-resistant bacterial lung infections with fewer treatment options available to them each day”, said David Melnick, M.D., Chief Medical Officer of Spero Therapeutics. “These promising results show that SPR206 achieves concentrations in lung epithelial lining fluid which may be sufficient to advance the development of SPR206 into clinical trials of patients with serious life-threatening pulmonary infections.”

“SPR206 has achieved an important milestone, as these data support our belief that SPR206 has the potential to offer therapeutic activity against MDR gram-negative lung infections,” said Ankit Mahadevia, M.D., Chief Executive Officer of Spero. “Together with our prior Phase 1 and pre-clinical data, we look forward to engaging with regulators as we plan the continued development of SPR206.”

About the SPR206 Bronchoalveolar Lavage (BAL) Trial
The Phase 1 BAL clinical trial was an open-label study designed to enroll 30 healthy volunteers into five cohorts. Subjects received three 100 mg doses of SPR206 infused every eight hours over one day. The objectives of the study were to evaluate the intrapulmonary pharmacokinetics (PK), including epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations of SPR206 compared to plasma concentrations to establish dose requirements for clinical efficacy of SPR206 in the setting of hospital-acquired pneumonia (HAP)/ventilator-associated pneumonia (VAP). This study was conducted in collaboration with, and with financial support from, the United States Department of Defense (Award No. W81XWH1910295).

About SPR206
SPR206 is an IV-administered next generation polymyxin product candidate designed to act directly on Gram-negative bacterial infections through the molecule’s interactions with the bacterial outer membrane.

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