Paldara and Mayo Clinic Advance Bacteriophage Hydrogel Platform Toward First Human Trials
Key Insights
Paldara pharmaceuticals (search) has partnered with Mayo Clinic to develop a novel hydrogel delivery system for bacteriophages (search) targeting antibiotic-resistant infections, with first-in-human trials potentially beginning as early as December.
The three-part platform microencapsulates bacteriophages (search) in sodium alginate spheres and embeds them in biocompatible hydrogel, providing controlled release over 7-14 days while protecting phages from immune system neutralization.
Mayo Clinic has successfully treated nearly 20 patients with phage therapy under FDA Expanded Access, demonstrating clinical potential against dangerous drug-resistant pathogens including the ESKAPE organisms.
Paldara pharmaceuticals (search) announced its collaboration with the Mayo Clinic to develop a novel bacteriophage delivery system through a hydrogel platform (search) designed to combat complex antibiotic-resistant infections. The partnership aims to advance phage therapy toward mainstream clinical practice, with first-in-human trials potentially beginning as early as December 2025.
Revolutionary Three-Part Delivery System
Paldara's platform addresses two critical obstacles that have long hindered phage therapeutics: localization and stabilization. The system employs a three-part approach where bacteriophages (search) are first microencapsulated in sodium alginate spheres to shield them from neutralizing antibodies. These microcapsules are then embedded within a biocompatible hydrogel matrix, enabling controlled and sustained delivery of consistent phage concentrations to infection sites over seven to 14 days.
"Our bacteriophage hydrogel platform (search) is designed to directly target and kill the bacterial strains driving these infections while preserving healthy microbiota," explained a Paldara spokesperson. "By localizing therapy to the site of infection and delivering phages in a controlled-release hydrogel, we reduce off-target effects, improve treatment efficacy, and provide a viable alternative where conventional drugs fail."
The hydrogel delivery method offers significant clinical versatility. Stored as a dry powder, it can be mixed into gel form within minutes and applied as catheter coatings, topical salves for burn wounds, or injectable treatments for post-surgical joint infections. This represents a substantial improvement over current phage treatments that often involve flooding wounds with phages in saline, leaving bacteria behind once wounds are closed and leading to recurrent infections.
Targeting the Most Dangerous Pathogens
The platform incorporates a comprehensive library of more than 200 therapeutic phages specifically targeting the most dangerous drug-resistant bacteria, including the notorious "ESKAPE" pathogens: Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii (search), Pseudomonas aeruginosa, and Enterobacter (search) species, as well as multidrug-resistant E. coli (search).
"Each phage is highly specific, often targeting only one bacterial species or even a single strain, which means they can eliminate harmful bacteria without disrupting the rest of the microbiome," the spokesperson noted. "Phages can evolve alongside their bacterial targets, maintaining long-term effectiveness."
Clinical Validation and Personal Mission
The collaboration leverages Mayo Clinic's clinical infrastructure and expertise in infectious disease management. Dr. Gina Suh, director of Mayo Clinic's phage therapy program and the only US physician known to treat patients successfully with phage therapy, brings critical clinical experience to the partnership.
"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," Dr. Suh stated. "Each case underscores both the urgency of the antimicrobial resistance crisis and the hope offered by innovations like Paldara's platform."
For William Colton, founder and CEO of Paldara, the fight against antibiotic resistance (search) carries deep personal significance. "My grandmother survived the Holocaust, built a life in America, and raised our family – only to die from a drug-resistant staph infection (search) after a routine hip replacement. We had no antibiotics left that could save her. That moment drives everything we do at Paldara."
Addressing a Global Health Crisis
The partnership tackles a critical global health challenge, as antibiotic resistance (search) has been attributed to 1.27 million deaths annually, with more than 35,000 fatalities occurring in the United States alone. Current phage therapy is often reserved for patients in critical condition under emergency use provisions, with success dependent on rapid matching of phages to specific infections.
By providing ready-to-use, shelf-stable phage formulations, Paldara aims to eliminate this bottleneck and scale treatment to real-world clinical settings. The technology is currently being evaluated for market fitness, clinical need, and its potential to improve bacteriophage therapeutic safety.
"We've got a lot more work to do, but once we save that first patient, that'll be everything," Colton emphasized, highlighting the transformative potential of making phage therapy accessible for mainstream clinical use.