OxThera’s current pipeline is built around exploring 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 also further diseases that could benefit from enteric biotherapy.
Oxabact® is produced from well characterized anaerobic cell banks. The bacteria can exclusively metabolize oxalate
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 in plasma
Our therapy can remove excess oxalate and may be able to deplete endogenous oxalate crystal deposits and thereby to preserve kidney function
Oxabact® has the potential to address
the systemic build-up of oxalate in organs like heart, 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 candidate. Oxalobacter formigenes is an anaerobe, non-pathogenic bacterium which exclusively uses oxalate as the energy source. Administration of the bacteria at pharmacological doses to PH patients is hypothezised to promote active, incremental secretion of oxalate into the gut where it is subject to degradation and enteric elimination. This highly innovative approach reroutes oxalate elimination to 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 potentially 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. Oxabact® is not yet approved and not yet on the market.
Pre-clinical and clinical studies have demonstrated effect and safety. Long-term efficacy and safety now need to be confirmed through an ongoing Phase III clinical study and a further long-term follow-up study. No comparable product is yet 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 composed of recombinant oxalate decarboxylase, an enzyme cloned from B. subtilis, for treatment of Secondary hyperoxaluria. It is formulated to enzymatically degrade available dietary oxalate prior to its absorption in the intestine. This 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 effect 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.