Can I receive the drug for compassionate use?
Our priority is to ensure completion of ongoing clinical study and that we will evaluate requests on a case by case basis depending on availability of drug. All requests should be made to our CMO
Do the bacteria exist in humans naturally?
Yes, the bacteria are natural inhabitants of the human gastrointestinal tract. However, not everyone is colonized with O. Formigenes. Oxalobacter is a Gram-negative bacteria, that is sensitive to antibiotics targeting this group of bacteria. Excessive use of antibiotics has decreased the prevalence of Oxalobacter in the natural flora. Studies are ongoing to demonstrate the link in increased prevalence of kidney stones to the decreased prevalence of Oxalobacter.
Can I change my diet to increase their presence in the body?
Some studies suggest that increasing dietary intake of oxalate together with decreasing intake of dietary calcium has a beneficial effect on the number of Oxalobacter in the gut. However, the therapeutic levels of Oxalobacter needed for treatment hyperoxaluria cannot be sustained by diet.
Why do you develop the enzyme Oxazyme®?
The intention for Oxazyme® is for the treatment of secondary hyperoxaluria, where the reason for hyperoxaluria is increased ingestion or malabsorption of oxalate. Oxazyme® is an enzyme that degrades oxalate from dietary sources. The enzyme acts in the gut. The degradation of oxalate by Oxazyme® prevents oxalate from being absorbed from the gut and into the body.
What could be the potential advantage of such an approach vis-à-vis the bacteria?
Oxabact® (Oxalobacter formigenes bacteria) and Oxazyme® (an enzyme that breaks down oxalate) act in different ways. While the primary mode of action of Oxabact® is to interact with the intestinal epithelial cells and promote the secretion of oxalate from the body (from blood plasma into the gut), Oxazyme® breaks down oxalate from dietary sources.