Merck & Co initiates first Ph I trial of NicOx agent

US drug major Merck & Co has initiated the first in a series of planned clinical studies, in mid-to-moderate hypertensive patients, under the companies' collaborative agreement to develop new nitric oxide-donating antihypertensive agents using France-based 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 evaluations in hypertensive patients involving single and multiple ascending dosing, prior to the selection of a compound to be advanced into Phase II. The most advanced candidate is now being evaluated in the first of these, 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.