By Clinical Research News Staff 

September 23, 2025 | Phage therapy, a treatment that uses viruses to fight bacterial infections, may finally be heading toward mainstream clinical practice. Paldara, a biotech startup, is developing a delivery platform that promises to stabilize and sustain bacteriophages and make phage therapy accessible for patients. 

The company’s work has caught the attention of the Mayo Clinic, which is now partnering with Paldara to advance the technology through both animal and human studies, as well as validate it for clinical use. If all goes as planned, a first-in-human clinical trial could begin as early as December.  

“We’ve got a lot more work to do, but once we save that first patient, that’ll be everything,” says William Colton, founder and CEO of Paldara.  

A Three-Part System Breaking Obstacles 

Paldara’s platform is built on a three-part system designed to overcome two key hurdles that have long hindered phage therapeutics: localization and stabilization. First, bacteriophages are microencapsulated in sodium alginate spheres to shield them from neutralizing antibodies and allow them to be released over seven to 14 days. These microcapsules are then embedded within a biocompatible hydrogel matrix, which enables controlled and sustained delivery of a consistent concentration of phages to the site of care, according to Colton.  

This delivery method not only boosts therapeutic efficacy but also adapts to multiple clinical scenarios. The hydrogel, stored as a dry powder, can be mixed into a gel within minutes and used as a catheter coating, topical salve for burn wounds, or injectable for post-surgical joint infections. In contrast, current phage treatments often involve flooding a wound with phages in saline—a method that leaves bacteria behind once the wound is closed, leading to recurrent infections. 

The platform also incorporates a library of more than 200 therapeutic phages targeting the most dangerous drug-resistant bacteria, including the notorious “ESKAPE” pathogens— Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter spp.—and multidrug-resistant E. coli. 

Dr. Gina Suh, director of Mayo Clinic’s phage therapy program, states that conventional therapies do not help all patients, which is why she started giving phages a chance. “At the Mayo Clinic, we have now treated nearly 20 patients with phage or phage-adjacent therapies under FDA Expanded Access, spanning a wide range of indications and bacterial pathogens,” she says. “Each case underscores both the urgency of the antimicrobial resistance crisis and the hope offered by innovations like Paldara’s platform.” 

Phage therapy today is often reserved for patients in critical condition under emergency use provisions, with success hinging on rapid matching of phages to a patient’s infection. By providing ready-to-use, shelf-stable phage formulations, Paldara aims to remove this bottleneck and scale treatment to real-world clinical settings. Colton relays that the technology is being evaluated for market fitness, clinical need, and how it can improve bacteriophage therapeutics safety. 

To read the full story written by Deborah Borfitz, visit Bio-IT World News.