Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.US-based Ore Pharmaceuticals, a drug development company, has completed dosing volunteer subjects in its multiple ascending dose Phase I clinical study of the company's lead drug candidate, GL1001, for the treatment of inflammatory bowel disease.
Subscribe to our email newsletter
The study, initiated in September 2008, was a blinded, placebo-controlled study in 32 healthy volunteers which studied multiple ascending doses up through the highest planned dose of 1800mg. The compound was orally administered once daily for 14 days. All of the dose levels were well tolerated and no serious adverse events were observed in any of the study cohorts, the company said.
Biomarker results from the study will be the subject of a future presentation in the first quarter of 2009. The findings from this study, combined with anticipated results from in vivo toxicology studies currently underway, are expected to support the company’s conduct of future proof-of-concept clinical studies.
GL1001, the first clinical-stage inhibitor of the ACE2 enzyme, is an orally administered small molecule that has decreased several disease activity measures in animal models of inflammatory bowel disease (IBD) and gastritis, said Ore Pharmaceuticals.
Stephen Donahue, senior vice president of clinical development for Ore Pharmaceuticals, said: We are very pleased to have completed multiple daily dose clinical testing of this novel drug candidate for treatment of IBD and look forward to initiating the next steps towards demonstrating GL1001 as an IBD therapy.