The main objectives of these studies are to evaluate safety, treatment duration, patient populations and a range of doses that will be incorporated into phase III pivotal trials. PT-141 is a melanocortin agonist that King and Palatin are jointly developing for the treatment of male and female sexual dysfunction.
The first phase IIb clinical trial will evaluate the safety and efficacy of PT-141 in 560 non-diabetic patients suffering from mild to severe erectile dysfunction. The second clinical trial will similarly evaluate 265 diabetic patients with the erectile disorder.
“The initiation of these two double-blind, placebo-controlled phase IIb clinical trials is a major milestone in the development of PT-141. We believe the data from this extensive phase IIb program will allow us to confidently select doses, end points and treatment periods for use in the design of the pivotal phase III trials,” commented Dr Carl Spana, CEO and president of Palatin Technologies.
The non-diabetic trial is scheduled to conclude in mid-2006, while the conclusion of the diabetic phase is scheduled to follow in the second half of 2006.