OxThera’s current pipeline is built around exploiting the therapeutic potential of Oxabact’s unique properties as an activated bimodal enteric biotherapy.
While we are pursuing this approach in Primary Hyperoxaluria as the lead indication, we believe there are further diseases that could benefit from enteric biotherapy.
Oxabact® in a Nutshell
Oxabact® is produced from well characterized anaerobic cell banks that exclusively metabolizes oxalate in the gut
Oxabact® is believed to emit signal peptides that both activate and enhance the excretion of oxalate from plasma into the gut preventing the harmful accumulation of oxalate
Our therapy can remove excess oxalate and may be able to deplete oxalate crystal deposits in order to preserve kidney function
Oxabact® has the potential to address
the systemic build-up of oxalate in organs like the heart, in bone and soft tissue
If developed successfully to market, Oxabact® will be the first orally delivered and therefore easy to use treatment for all patients suffering from Primary Hyperoxaluria
Taken together, Oxabact® represents a first-in-class approach as an Activated Bimodal Enteric Biotherapy for a severe rare metabolic disorder
To address PH, OxThera has taken a bacterial strain isolated from the human gut and developed a live biotherapeutic product. Oxalobacter formigenes is an anaerobe, non-pathogenic bacterium which exclusively uses oxalate as an energy source. Administration of the bacteria at pharmacological doses to PH patients promotes active, incremental secretion of oxalate into the gut where it is subjected to degradation and enteric elimination. This highly innovative approach reroutes oxalate elimination via the gut thereby reducing the high oxalate burden on the kidneys. In the short-term, this could prevent disease progression, and longer term, dialysis may potentially be avoided. O. formigenes would prevent crystallization and potentially mobilize and remove systemic CaOx deposits preventing end-organ damage. We consider this unique concept the ideal model for treatment of chronic, life-threatening metabolic diseases with a biological product.
Pre-clinical and clinical studies have demonstrated functionality and safety. Long-term efficacy and safety now need to be confirmed through an ongoing Phase III clinical study and a further long-term confirmatory study to prove clinical benefit. No comparable product is on the market, it is OxThera’s intention to demonstrate to patients, clinicians, healthcare payers and regulators that our first-in-class approach, Oxabact®, provides clinical benefit for patients.
Oxazyme® is an orally delivered drug candidate composed of recombinant oxalate decarboxylase, an enzyme abundant in B. subtilis for treatment of Hyperoxaluria. It is formulated to enzymatically degrade available dietary oxalate prior to its absorption. The drug candidate is designed as a dietary intercept therapeutic for enteric and absorptive hyperoxalurias causing recurrent stone disease. The objective with Oxazyme® is to prevent formation of calcium-oxalate kidney stones.
Pre-clinical and early phase clinical studies have demonstrated functionality and safety. Long-term efficacy and safety still need to be confirmed through additional Phase II and Phase III clinical studies to prove clinical benefit.