DUOFAG® and its journey to conquest diabetic foot infections

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216224%3A14310%2F22%3A00129691" target="_blank" >RIV/00216224:14310/22:00129691 - isvavai.cz</a>

Výsledek na webu

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DOI - Digital Object Identifier

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Jazyk výsledku

angličtina

Název v původním jazyce

DUOFAG® and its journey to conquest diabetic foot infections

Popis výsledku v původním jazyce

In Czechia, the history of phage therapy research dates back to interwar Czechoslovakia, but currently, phage therapy is almost unavailable there. Over the last decade, MB PHARMA has been working on phage research and has developed the phage cocktail DUOFAG®. This cocktail comprises phages active against Staphylococcus aureus and Pseudomonas aeruginosa. DUOFAG® is intended for diabetic foot infections treatment but has the potential for curing other types of infections too. DUOFAG® comprises two phages active against S. aureus and one phage active against P. aeruginosa. The phages characterized on morphological and genomic levels have their host ranges examined on hundreds of clinical isolates of bacteria. DUOFAG® is manufactured in a Czech GMP-certified facility. Elaborate release testing discussed with the State Institute for Drug Control ensures the quality of DUOFAG®. The stability of phages is evaluated regularly. MB PHARMA has established a seed lot system for phages and propagation bacteria. DUOFAG® was examined in preclinical animal studies. Acute dermal toxicity study on rats and local dermal tolerance study on rabbits confirmed the safety of DUOFAG®. Follow-up preclinical studies focusing on subcutaneous administration of DUOFAG® are currently underway. Single and repeated dose toxicity and toxicokinetics studies of DUOFAG® are performed on rats. According to data from Czech hospitals, S. aureus and P. aeruginosa are the main causative agents of diabetic foot infections. The upcoming clinical evaluation of DUOFAG® focuses on proving the safety, tolerability, and efficiency of multiple doses of DUOFAG® in subjects with infected diabetic foot ulcers. The first cohort of patients will be observed for safety evaluation of DUOFAG®, and possible adverse effects will be monitored. In Cohort 2, the study will continue as a double-blind, randomized add-on study of DUOFAG® vs. placebo. The wound healing rate and the microbiological load will be evaluated.

Název v anglickém jazyce

DUOFAG® and its journey to conquest diabetic foot infections

Popis výsledku anglicky

In Czechia, the history of phage therapy research dates back to interwar Czechoslovakia, but currently, phage therapy is almost unavailable there. Over the last decade, MB PHARMA has been working on phage research and has developed the phage cocktail DUOFAG®. This cocktail comprises phages active against Staphylococcus aureus and Pseudomonas aeruginosa. DUOFAG® is intended for diabetic foot infections treatment but has the potential for curing other types of infections too. DUOFAG® comprises two phages active against S. aureus and one phage active against P. aeruginosa. The phages characterized on morphological and genomic levels have their host ranges examined on hundreds of clinical isolates of bacteria. DUOFAG® is manufactured in a Czech GMP-certified facility. Elaborate release testing discussed with the State Institute for Drug Control ensures the quality of DUOFAG®. The stability of phages is evaluated regularly. MB PHARMA has established a seed lot system for phages and propagation bacteria. DUOFAG® was examined in preclinical animal studies. Acute dermal toxicity study on rats and local dermal tolerance study on rabbits confirmed the safety of DUOFAG®. Follow-up preclinical studies focusing on subcutaneous administration of DUOFAG® are currently underway. Single and repeated dose toxicity and toxicokinetics studies of DUOFAG® are performed on rats. According to data from Czech hospitals, S. aureus and P. aeruginosa are the main causative agents of diabetic foot infections. The upcoming clinical evaluation of DUOFAG® focuses on proving the safety, tolerability, and efficiency of multiple doses of DUOFAG® in subjects with infected diabetic foot ulcers. The first cohort of patients will be observed for safety evaluation of DUOFAG®, and possible adverse effects will be monitored. In Cohort 2, the study will continue as a double-blind, randomized add-on study of DUOFAG® vs. placebo. The wound healing rate and the microbiological load will be evaluated.

Druh

O - Ostatní výsledky

CEP obor

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OECD FORD obor

10600 - Biological sciences

Projekt

<a href="/cs/project/NU21J-05-00035" target="_blank" >NU21J-05-00035: Synergie lytických bakteriofágů a antibiotik v léčbě povrchových infekcí způsobených Staphylococcus aureus</a><br>

Návaznosti

P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Rok uplatnění

2022

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů