Locus Biosciences receives $23.9 million from BARDA for CRISPR-engineered therapy trial

Durham-based Locus Biosciences has received $23.9 million in funding from the Biomedical Advanced Research and Development Authority (BARDA) to begin a blinded, placebo-controlled clinical trial of its CRISPR-enhanced bacteriophage therapy, LBP-EC01. The product kills targeted bacteria by irreversibly destroying their DNA while leaving the many species of beneficial bacteria in the body unharmed.

The ELIMINATE trial will evaluate LBP-EC01 for treating urinary tract infections caused by drug-resistant E. coli.

“This will be the first time ever that the world gets to see definitive proof that engineered phage can help exceed what you would get from antibiotics alone and maybe eventually replace antibiotics,” said Locus Co-founder and CEO Paul Garofolo. “This would be a huge step forward for the company, for the field, and for society to be able to address MDR [multi-drug resistant bacterial infections], and this is, of course, why BARDA is so supportive of it.”

According to a press release issued by Locus, engineered bacteriophage addresses a public health crisis related to MDR bacterial infections. Locus will use the BARDA funding to evaluate LBE-EC01 in combination with trimethoprim/sulfamethoxazole (TMP/SMX) in adult female patients for the treatment of uncomplicated UTIs caused by drug-resistant E. coli. The therapy’s efficacy will be compared to a control of placebo plus TMP/SMX. 

In 2020 Locus and BARDA, which is part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, entered a contract of up to $85 million to co-fund the development of LBP-EC01. The nearly $24 million in funding will be used to advance LBP-ECO1 into the blinded, placebo-controlled Part 2 of the ELIMINATE Phase 2 trial, the company says. Locus recently completed Part 1 of ELIMINATE, an uncontrolled open-label trial.

The $23.9 million in funding brings the amount released under the contract to $48.9 million.