Ore Pharmaceuticals Announces Completion Of Multiple Ascending Dose GL1001 Clinical Phase 1 Trial

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Irritable-Bowel Syndrome;  Clinical Trials / Drug Trials
Article Date: 07 Dec 2008 - 2:00 PST

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Ore Pharmaceuticals Inc. (NASDAQ: ORXE) today announced that it has completed dosing volunteer subjects in its multiple ascending dose clinical study of the Company's lead drug candidate, GL1001. The study, initiated in September, 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. Biomarker results from the study will be the subject of a future presentation in 1Q 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.

The efficacy of GL1001 in animal models is being presented in two poster presentations at the Crohn's and Colitis Foundation's Advances in Inflammatory Bowel Disease Conference being held this week in Hollywood, Florida. The first poster shows the effects of GL1001 treatment on dextran sodium sulfate-induced colitis in mice, and demonstrates that treatment with GL1001 significantly improved multiple endpoints, including morphological appearance of the colon. The Company's second poster demonstrates that the inhibition of ACE2 by GL1001 is gastro-protective against NSAID-induced gastric damage in rats and demonstrates significant improvement in the level of healing of chronic ulcers in a rat model. In animal models, treatment with GL1001 was associated with statistically significant decreases in pro-inflammatory cytokines such as TNF-alpha.

Stephen Donahue, M.D., 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." Charles L. Dimmler, III, Ore Pharmaceuticals' CEO, added, "Achieving this important milestone for GL1001 supports our commitment to later stage clinical testing and enhances our ability to find a viable partner to help us to further advance this exciting first in class compound."

GL1001 Overview

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. GL1001 was administered previously in a Phase I single ascending dose clinical study where it was well tolerated through 2100 mg and exhibited favorable pharmacokinetics consistent with once daily dosing. Ore Pharmaceuticals repositioned GL1001 from its original indication, obesity, and is pursuing its clinical development in parallel with its efforts to out-license or partner the development of the compound in later-stage clinical trials.

Ore Pharmaceuticals Overview

Ore Pharmaceuticals is a commercial drug development company. We have applied our proprietary know-how in integrative pharmacology to identify potential new uses for drug candidates. We are now focused on developing certain compounds for which we have found new uses. Ore Pharmaceuticals currently has three compounds in its development pipeline: romazarit (beginning development for metabolic disorders), tiapamil (beginning development for treatment of diseases of the central nervous system), and GL1001 (in development for inflammatory bowel disease). We are currently seeking a development partner for late-stage development of GL1001, romazarit and tiapamil. We are currently seeking to obtain rights to develop additional compounds for which we have found new uses.

http://www.orepharma.com