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NicOx announces initiation of first phase 1 study of investigational nitric oxide-donating agent in hypertensive patients

14 May 2008 - NicOx S.A. announced that Merck & Co., Inc. has initiated the first in a series of planned clinical studies, in mild to moderate hypertensive patients, under the companies' collaborative agreement to develop new nitric oxide-donating antihypertensive agents using NicOx' proprietary technology. Three drug candidates have now been selected from the companies' joint research program, of which two have completed initial dose ranging studies in healthy volunteers under the exploratory clinical study paradigm with encouraging results.
 
Merck plans to conduct a number of clinical studies in hypertensive patients involving single and multiple ascending dosing, prior to the selection of a compound to be advanced into phase 2. The most advanced candidate is now being evaluated in the first of these studies, which is a single ascending dose trial in mild to moderate hypertensive patients. The main objectives of this study are to assess the efficacy, safety, tolerability and pharmacokinetics of single ascending doses of this candidate. Subsequent studies will assess multiple ascending doses.
 
"The initiation of this series of clinical studies in hypertensive patients is a very important step towards delivering a new treatment paradigm for hypertension, where the medical need remains significant," commented Jacques Djian MD., NicOx' Cardiometabolic Area Leader. "We believe these drug candidates have considerable potential as improved antihypertensive agents based on their nitric oxide-donating properties and we hope they will deliver a major advance in antihypertensive treatment for patients worldwide."
 
In July 2007, NicOx announced the initiation of the first in a series of studies in healthy volunteers for the selected candidates (see press release of July, 16th 2007). Merck is responsible for funding and performing the development of these compounds going forward.