Date: 2014-01-08
Type of information:
phase: 1
Announcement: initiation of the trial
Company: OxThera (Sweden)
Product: Oxabact® (Oxalobacter formigenes strain HC-1)
Action mechanism: Oxabact® is an oral product composed of highly concentrated freeze-dried live bacteria (Oxalobacter formigenes), administered in capsules. The drug is designed for delivery to the small intestine where enteric elimination of endogenous oxalate is initiated. A complete clinical development plan for Oxabact® has been implemented for the treatment of patients suffering from Primary Hyperoxaluria.
Disease: primary hyperoxaluria
Therapeutic area: Rare diseases
Country:
Trial details:
Latest
news: * On January 8, 2014, OxThera, a Stockholm-based privately-held biopharmaceutical company, has announced that it has initiated a clinical study with Oxabact® in primary hyperoxaluria. The placebo-controlled clinical trial, OC5-DB-01, is conducted at 7 clinical sites in three countries and will include a total of 24 patients. Results are expected after summer next year. The drug is designed for delivery to the small intestine where enteric elimination of endogenous oxalate is initiated. A complete clinical development plan for Oxabact® has been implemented for the treatment of patients suffering from Primary Hyperoxaluria. Oxabact® holds orphan drug designations in the EU and the US for the treatment of PH.
