The Phase I trial was a randomized, double-blind, placebo-controlled, single ascending dose study in 26 healthy volunteers who received the medication or placebo subcutaneously. The objective of the trial was to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneously administered PL-3994 in healthy male subjects.
Dosing was concluded with the successful achievement of the primary endpoint of the study, a prespecified reduction in systemic blood pressure. PL-3994 produced dose-related decreases in blood pressure, increases in plasma cGMP, and increases in urine volume and sodium excretion.
Carl Spana, president and CEO of Palatin, said: “A clinical study is targeted to start later this calendar year which will randomize chronic heart failure patients to receive daily subcutaneous injections of PL-3994 in addition to their existing drug regimens. While existing medications are effective in reducing symptoms, reducing the rate of hospitalization and extending life, chronic heart failure patients nonetheless have poor prognoses.”