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news.Breakthrough medicines developer Alteon has initiated a phase II trial of its novel compound alagebrium chloride to assess its ability to treat erectile dysfunction in diabetic patients.
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Alagebrium has demonstrated an ability to reverse erectile dysfunction (ED) in a preclinical model of ED in diabetic rats, through what appears to be a unique mechanism of action. Thus it may offer significant potential as an adjunctive treatment for diabetic ED.
The trial, named EMERALD, will assess the ability of alagebrium chloride (formerly known as ALT-711) to restore erectile function in diabetic patients with moderate to severe ED who achieve limited benefit from current treatment with phosphodiesterase type 5 (PDE5) inhibitors, the first class of orally active compounds approved for the treatment of ED.
Approximately 40 male diabetic patients age 18 to 70 will be enrolled in the trial and randomized to receive oral doses of either alagebrium or placebo tablets for a 16- week period, in conjunction with their PDE5 inhibitor therapy.
The primary endpoint of the trial will be based on the International Index of Erectile Function (IIEF) questionnaire. Secondary endpoints of efficacy will be self-reported improvement in erections and measurements of change from baseline in penile blood flow.
“Alagebrium appears to have a unique mechanism of action and significant therapeutic potential for the treatment of diabetic erectile dysfunction,” said Dr Wayne Hellstrom, professor of urology at Tulane University School of Medicine and an author of many of the seminal studies in ED.
In prior clinical and preclinical studies, alagebrium appeared to have a remodeling effect on the cardiovascular system as well as a positive effect on systolic hypertension and vascular compliance. The drug is currently in phase II studies in patients with hypertension and heart failure. In addition, it is being studied for its effect on endothelial dysfunction, a condition also linked to ED.
Many studies have identified ED as an early indicator of cardiovascular diseases, including hypertension, heart attack and stroke, and point to the underlying dysfunction of the arteries and vascular system as a principal cause.
ED is commonly associated with a number of other conditions frequently occurring in aging men, including prostatic hypertrophy, arterial hypertension, ischemic heart disease, peripheral vascular disease, atherosclerosis, hyperlipidemia, and diabetes mellitus.