CAMBRIDGE, Mass. and NESS ZIONA, Israel — BiomX Inc., a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced that its phage cocktail, BX004, has been granted Orphan Drug Designation (“ODD”) by the United States Food and Drug Administration (“FDA”), for the treatment of chronic pulmonary infection caused by Pseudomonas aeruginosa (or P. aeruginosa) in patients with cystic fibrosis (“CF”). As a reminder, in August 2023, the FDA granted BX004 Fast Track designation for the treatment of chronic pulmonary infections caused by P. aeruginosa bacterial strains in patients with CF.
“We are pleased to announce that the FDA has granted BX004 Orphan Drug Designation, which underscores the pressing need to develop new and innovative treatment options for this vulnerable patient population,” said Jonathan Solomon, Chief Executive Officer of BiomX. “Persistent and deadly pulmonary infections from P.aeruginosaremain a major source of morbidity and mortality for CF patients, andBX004 has been designed to address this significant unmet need. Based upon positive topline results observed in our Phase 1b/2a trial, we believe BX004 holds significant potential to improve upon the current standard of care, and we look forward to working with the FDA to further advance the clinical development of BX004.”
About Orphan Drug Designation (ODD)
An orphan drug is defined in the 1984 amendments of the U.S. Orphan Drug Act (ODA) as a drug intended to treat a condition affecting fewer than 200,000 persons in the United States. Orphan designation qualifies the sponsor of the product for seven-year marketing exclusivity to the first sponsor obtaining FDA approval of a designated drug, a tax credit equal to 50% of clinical investigation expenses, exemption/waiver of the Prescription Drug User Fee Act (PDUFA) application filing fees, assistance in the drug development process, and Orphan Products Grant funding eligibility.1
About BX004
BiomX is developing BX004, utilizing its proprietary BOLT platform, for the treatment of CF patients with chronic pulmonary infections caused by P. aeruginosa, a main contributor to morbidity and mortality in patients with CF. In September 2021, BX004 was cleared by the FDA to initiate a Phase 1b/2a study in CF patients with chronic pulmonary infections caused by P. aeruginosa. The Phase 1b/2a trial was composed of two parts. Part 1 of the study evaluated the safety, pharmacokinetics, and microbiologic/clinical activity of BX004 in nine CF patients in a single ascending dose and multiple dose design. Part 2 of the study evaluated the safety and efficacy of BX004 in 34 CF patients randomized to treatment or placebo in a 2:1 ratio. Positive topline results from Part 2 of the study were announced on November 29, 2023. In August 2023, the FDA granted BX004 Fast Track designation for the treatment of chronic pulmonary infections caused by P. aeruginosa bacterial strains in patients with CF.
About BiomX
BiomX is a clinical-stage company developing both natural and engineered phage cocktails designed to target and destroy bacteria in the treatment of chronic diseases. BiomX discovers and validates proprietary bacterial targets and customizes phage compositions against these targets.
Contacts
Investor Relations
LifeSci Advisors, LLC
John Fraunces
(917) 355-2395
[email protected],
LifeSci Advisors, LLC
Brian Mullen
(203) 461-1175
[email protected]
BiomX, Inc.
Anat Primovich
Corporate Project Manager
+972 (50) 697-7228
[email protected]