BiomX - Model IBD/PSC - BX003 - Orally Administered Phage Cocktail
From Pipeline
BX003 is an orally administered phage cocktail targeting a bacterial target present in the gut of IBD and PSC patients and thought to be associated with the onset or exacerbation of these diseases. Although different organs are affected in IBD and PSC (gut in IBD and liver in PSC) the two diseases are thought to be related since approximately 70% of PSC patients also suffer from IBD. Results from a pharmacokinetic and safety Phase 1a study demonstrated safety and tolerability with successful delivery of a high concentration of viable phage to the lower gastrointestinal tract.
Unmet Need
Current IBD treatments address disease symptoms and consist mainly of anti-inflammatory and immunosuppressive therapies, depending on the patient’s disease severity. Response rates to the most advanced biological therapies are about 40-60%. In addition, many of the patients that do respond initially become refractory to a given therapy within 12-18 months and are required to switch to an alternative biological therapy.
PSC is a rare progressive liver disorder with no FDA-approved treatment. PSC affects approximately 30,000 patients in the U.S. It is characterized by inflammation and fibrosis of the bile ducts, which often results in the obstruction or interruption of bile flow from the liver, a condition known as cholestasis. Without a liver transplant, patients with PSC have a median survival period after diagnosis of nine to eighteen years. Even following liver transplantation, approximately 40% of patient experience recurrence of PSC disease.
Mode of Action
BX003 targets bacterial strains of Klebsiella pneumoniae present in the gut of IBD and PSC patients. In two separate animal studies, different Klebsiella pneumoniae strains were shown to increase disease severity: colitis in IBD models and elevated liver enzymes and fibrosis in PSC models. The suggested underlying mechanism is induction of pro-inflammatory responses characteristic of these diseases, suggesting that these strains may have a role in the onset and aggravation of these diseases (see publication in Science and in Nature Microbiology ). These strains were also shown to cause gut permeability or a “leaky gut” that may lead to inflammation in gut in IBD patients and microbial infection of bile ducts, resulting in inflammation and fibrosis within the liver of PSC patients. BX003 is characterized by a broad bacterial host range targeting Klebsiella pneumoniae strains present in the gut of both IBD and PSC patients.
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