SER100 for the treatment of resistant hypertension in the elderly.

Results from the first clinical trial of SER100 in patients With isolated systolic hypertension were presented in September. SER100 was safe and well tolerated in these patients. Treatment with SER100 produced an average reduction of 7 mmHg over the treatment period compared to placebo. A Maximum fall of 12 mmHg in systolic blood pressure was seen 3-5 hours after dosing. The effects were statistically significant. The work at Queen Mary's University in London has produced interesting results. The effect of SER100 on blood pressure corresponds to that of nociceptin. The effect seems to be composed of several independent mechanisms.

Isolated Systolic Hypertension (ISH) is the dominating hypertensive disease in elderly people. This form of hypertension is often difficult to control. Uncontrolled hypertension is a very serious burden to the society, affecting 25 % of the adult populat ion. Hypertension is the direct cause of 7,6 million premature deaths annually, and nearly half of all strokes and other ischaemic cardiovascular events are caused by systolic hypertension. New therapeutic approaches to effective and safe treatment are t herefore needed. The present research project aims to document that SER100, a new compound with a first-in-class mode of action, is safe and can provide a selective reduction of systolic blood pressure in elderly, thiazide-resistant ISH patients. SER100 is a hydrophilic peptide with a partial agonistic effect on the ORL1 (opioid) receptor similar to that of the endogenous peptide nociceptin. Earlier clinical studies in other patient populations (acute and chronic heart failure) unexpectedly revealed a significant drop in systolic blood pressure, with only minor effects on diastolic pressure. The observed effect of SER100 on systolic pressure is difficult to explain on the basis of its known pharmacology. The main objectives of the project is to ident ify the pharmacological mechanism behind the selective drop in systolic pressure and to verify that SER100 provides a safe and clinically meaningful reduction of systolic pressure in patients with isolated systolic hypertension. A positive outcome of the project will result in a decision to initiate further clinical development of SER100, through Phase II dose-ranging studies, larger Phase III studies and applications for market authorisations in most major countries.