Spero Therapeutics Initiates First Clinical Study of Lead Potentiator Candidate for the Treatment of Multidrug Resistant Gram-Negative Infections

CAMBRIDGE, Mass., Dec. 19, 2016 /CNW/ -- Spero Therapeutics, LLC, a biopharmaceutical company founded to develop novel therapies for the treatment of bacterial infections, today announced the initiation of a Phase 1 clinical trial of SPR741, the Company's lead Potentiator molecule. The Potentiator Platform identifies novel chemical entities that disrupt the outer cell membrane of Gram-negative bacteria to permit access for a range of antimicrobial agents previously only active against Gram-positive pathogens.

"With the increasing number of infections resistant to multiple drugs, the need for new approaches to fight these infections has never been greater," said Ankit Mahadevia, M.D., Chief Executive Officer of Spero. "We have completed a robust preclinical program evaluating SPR741 in combination with new and existing antibiotics against some of the most deadly multidrug resistant infections and are excited to be moving into the clinical phase of testing. Our hope is that with the Potentiator Platform, as well as our pipeline of other novel therapies advancing into clinic next year, we can begin to address the global crisis of antibiotic resistance."

The Phase 1 clinical trial is a double-blind, placebo-controlled, ascending dose, multi-cohort trial evaluating safety, tolerability and pharmacokinetics of SPR741. The study will be conducted in two phases: a single ascending dose (SAD) phase, and a multiple ascending dose (MAD) phase. In the SAD phase, 64 healthy volunteers will receive one dose of SPR741 or placebo. In the MAD phase, 32 healthy volunteers will receive multiple doses of SPR741 or placebo for 14 consecutive days. In both parts, sequential cohorts will be exposed to increasing doses of SPR741. Spero expects top-line data from the clinical trial in 2017.

About The Spero Potentiator Platform

Spero's Potentiator Platform identifies novel chemical entities that disrupt the outer cell membrane of Gram-negative bacteria to permit access for a range of antimicrobial agents previously only active against Gram-positive pathogens. Potentiator molecules are designed to specifically and potently disrupt the lipopolysaccharide (LPS) in the outer membrane of Gram-negative bacteria. LPS acts as the persistent barrier to entry for Gram-positive antimicrobial agents. Spero in-licensed the rights to SPR741 from Northern Antibiotics, Espoo, Finland.

About SPR741

SPR741 is Spero's lead Potentiator candidate. Preclinical studies of SPR741 in combination with Gram-positive antibiotics have shown success in reducing the bacterial burden of infections caused by several common drug-resistant pathogens, including Escherichia coli, Acinetobacter baumannii, and Klebsiella pneumoniae. Spero communicated the pre-clinical broad-spectrum efficacy, safety and pharmacokinetics of SPR741 in 14 posters and an oral presentation at ASM Microbe 2016 in Boston, Mass.

About Spero

Spero Therapeutics, headquartered in Cambridge, Massachusetts, is a multi-asset biopharmaceutical company developing a pipeline of novel treatments for bacterial infections. The company's pipeline of anti-infective agents is one of the most unique in the industry. The Spero Potentiator Platform provides the opportunity to increase the power of standard of care by enhancing existing drugs through a dramatic increase in their potency against multi-drug resistant Gram-negative bacteria. The DHFR program is exploring a new approach to combatting drug resistance through expansion of a novel antifolate's antibacterial spectrum to treat trimethoprim-resistant Gram-negative bacteria. In September 2016, Spero joined the ENABLE (European Gram-negative Antibacterial Engine) project, which provides non-dilutive resources for the development of the DHFR program.

Spero's pipeline of drug candidates may uniquely reduce the morbidity caused by severe infections and promote their clearance, including in bacterial strains highly resistant to even the most potent existing antibiotics. For more information, please visit https://sperotherapeutics.com.


SOURCE Spero Therapeutics

For further information: Spectrum Science Communications: Maia Arnold, PhD, Senior Scientific Executive, 202-955-6222 x2506, marnold@spectrumscience.com; Stern Investor Relations, Inc: Beth DelGiacco, Vice President, 212-362-1200, beth@sternir.com, https://sperotherapeutics.com

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