Biomx raises $12M to advance phage therapy for CF infections
Financing will support clinical trial of BX004 for P. aeruginosa infections
Biomx has raised $12 million in financing to advance BX004, a phage therapy being developed to treat bacterial infections — specifically, ones caused by Pseudomonas aeruginosa, known as P. aeruginosa for short — in people with cystic fibrosis (CF).
The funding comes from investors purchasing the company’s stock, or securing the right to purchase stock at a set price later on. The Cystic Fibrosis Foundation, which has already invested $10 million in the development of BX004, played a major role in the new round of financing, according to Biomx.
The company said the new funds will help support a Phase 2b clinical trial of BX004 in CF patients with P. aeruginosa infections.
“Following these offerings, we expect to have sufficient funding to reach substantial inflection points including topline results of our Phase 2b study of BX004 in [the first quarter of] 2026,” Jonathan Solomon, CEO of Biomx, said in a company press release.
Developer will also use funding to research real-world impact of CF infections
CF is caused by mutations in the gene that provides instructions to make CFTR, a protein that plays a central role in regulating the production of mucus in the body. Dysfunctional or absent CFTR protein in CF leads the body to produce unusually thick and sticky mucus, which builds up in the lungs and other organs.
Such thick mucus in the lungs provides a fertile breeding ground for bacteria, and due to that, bacterial lung infections can be a frequent problem for people living with CF. P. aeruginosa is one of the most common causes of these problematic lung infections in CF patients. Antibiotics, or bacteria-killing medications, can help treat these infections to an extent. However, bacterial resistance to antibiotics is increasingly making these medicines less effective.
Bacteriophages, commonly called phages for short, are viruses that are able to infect and kill bacteria. BX004 contains a cocktail of phages specifically designed to infect and destroy P. aeruginosa bacteria.
A previous Phase 1b/2a clinical trial (NCT05010577) indicated that BX004 was better than a placebo at improving lung function in CF patients with P. aeruginosa infections. Importantly, the researchers had noted, the phage therapy reduced the number of infectious bacteria in patients without showing signs of resistance.
Peer-reviewed publications report findings supporting the link between P. aeruginosa reduction and improved clinical outcomes in people with CF.
In addition to supporting the upcoming Phase 2b study, Biomx will be using the funding to conduct research on the real-world impacts of P. aeruginosa infections. Pursuant to discussions with the U.S. Food and Drug Administration (FDA), the company hopes that these data will help support future applications related to BX004.
“Peer-reviewed publications report findings supporting the link between P. aeruginosa reduction and improved clinical outcomes in people with CF,” Solomon said. “Following communication with the FDA we intend to present our plans to analyze real-world evidence and attain endorsement that supports potential future regulatory filings.”
The FDA has awarded both fast track and orphan drug designations to BX004. Fast track status is designed to expedite the development and review of new therapies that address unmet medical needs. Orphan drug designation is awarded to treatments for rare diseases, or conditions affecting fewer than 200,000 people in the U.S.
“We anticipate further discussion with the FDA and European Committee for Medicinal Products for Human Use (CHMP) later this year to discuss our proposed plan,” Solomon said.
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