BiomX has created a new phage oral therapy that targets specific bacteria, thought to exacerbate symptoms, in the gut of IBD patients. This new possible treatment is in the pipelines, but has shown promising results in its Phase 1 human trials. This new therapy, called BX003, works by using bacteriophages (phages)which are viruses that infect and kill specific bacterial cells. This particular mix of phages aims to target Klebsiella pneumoniae, an abundant bacteria in the gut biomes of IBD and PSC (primary sclerosing cholangitis) patients. PSC affects the bile ducts of the liver, and is considered to be a rare progressive disease, although it affects about 30,000 Americans. Great similarity has been found in the gut biomes between IBD and PSC patients, and approximately 70% who suffer from PSC will be diagnosed with IBD as well.Â
In this Phase 1 clinical trial 18 volunteers were obtained. The new phage therapy was given to 14 of the 18 participants two times a day for three consecutive days. The other 4 people were given a placebo to keep it blind. As Phase 1 is the first in human trials, the main goal was to study safety and tolerability. All 18 participants were monitored for a total of 4 weeks after treatment. Overall, the safety profile was positive, and no serious reactions were reported. Out of all 18 volunteers, none of them had to stop the study due to reactions either, which is a huge step forward to getting this new therapy to Phase 2 trials. The oral phage cocktail is powerful enough to deliver almost 10 billion units to the intestinal tract, getting in quickly and being able to act right away.Â
While there is still lots of research to do for BX003, the tolerability of this new phage therapy makes it an up-and-coming possibility for treatment. Biomx has plans to do Phase 1b/2a study, with the success of the first phase, by the end of 2022. Current IBD treatments, such as biologics, target the immune system by suppressing it. While biologics have received lots of praise for IBD, only 40-60% of patients respond to these treatments. As for PSC, there is no FDA approved medication to treat it as of now, and even for those that get liver transplants 40% will have PSC return. This new way of targeting bacteria could be revolutionary in managing both of these diseases.Â
This treatment is unlike anything that is available now, as it targets a completely different spectrum of bacteria. More and more, researchers are finding specific bacteria associated with IBD and ‘leaky gut’. These specific bacteria could be the underlying cause of the proinflammatory immune response. The specific strains were shown to affect gut permeability, which is a huge problem in the intestines of those with IBD and PSC. By targeting the bacteria rather than the immune response, this new BX003 could get ahead of the body’s immune reaction putting the patient more in control of their chronic illness and their gut biome. Â
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