FDA clears Spero Therapeutics' phase 2 trial for SPR206

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FDA clears Spero Therapeutics' phase 2 trial for SPR206
Credit: © Reuters.

CAMBRIDGE, Mass. - Spero Therapeutics , Inc. (NASDAQ: SPRO ), a biopharmaceutical company engaged in the development of treatments for rare diseases and multi-drug resistant infections, announced today that the U.S. Food and Drug Administration (FDA) has granted clearance for its investigational new drug (IND) application.

This clearance will allow Spero to proceed with a Phase 2 clinical trial for SPR206, an intravenous antibiotic designed to combat hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) due to multi-drug resistant (MDR) Gram-negative bacteria.

The Chief Medical Officer of Spero, Kamal Hamed, remarked on the significance of this milestone, emphasizing the serious nature of HABP/VABP infections and the growing challenge posed by MDR pathogens. SPR206 aims to meet this critical healthcare need, potentially offering a new option for treatment.

The upcoming Phase 2 study is set to be a randomized, double-blinded, controlled, multicenter trial evaluating the safety, efficacy, tolerability, and pharmacokinetics of SPR206 in combination with select antibiotics.

The trial will enroll approximately 60 adult hospitalized patients with infections caused by carbapenem-resistant bacteria, including Acinetobacter baumannii-calcoaceticus complex and Pseudomonas aeruginosa. These patients will undergo treatment for 7 to 14 days, with their clinical outcomes assessed post-baseline.

SPR206's development has been part of a licensing agreement with Pfizer Inc. (NYSE: PFE ), which also included a $40 million equity investment in Spero in June 2021. Under this agreement, Pfizer has the rights to develop, manufacture, and commercialize SPR206 outside of the U.S. and Asia. Spero could receive up to $80 million in development and sales milestones, in addition to royalties on net sales in these territories.

Previously, SPR206 has shown promising broad-spectrum activity against Gram-negative bacteria in preclinical studies and has been well-tolerated in Phase 1 trials without evidence of nephrotoxicity. The drug has also received Qualified Infectious Disease Product (QIDP) designation from the FDA for the treatment of complicated urinary tract infections and HABP/VABP.

This advancement in Spero's clinical program has been supported by various government entities, including the Department of Defense and the National Institute of Allergy and Infectious Diseases. The company has a portfolio of other products in development, focusing on addressing the unmet needs in bacterial infections and rare diseases.

The information in this article is based on a press release statement.

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