The Phase IIa trial was a randomized, double-blind, placebo-controlled, single ascending dose study in 21 volunteers with controlled hypertension who received the medication or placebo subcutaneously.
The purpose of the study was to demonstrate that PL-3994 can be given safely to patients taking antihypertensive medications commonly administered to heart failure and hypertension patients. The evaluations included safety, tolerability, pharmacokinetics and several pharmacodynamic endpoints, including levels of cyclic guanosine monophosphate (cGMP), a natural messenger nucleotide.
Dosing concluded with the successful achievement of the primary endpoint of the study, a pre-specified reduction in systemic blood pressure. No volunteer experienced a serious or severe adverse event.
Elevations in plasma cGMP levels were all observed for several hours after single subcutaneous doses. Additional data analysis is ongoing and will be submitted for presentation when the analysis is complete.
Trevor Hallam, executive vice president of R&D at Palatin, said: “We are excited to confirm that PL-3994 can be given safely to patients who are taking blood pressure medications. As we proceed with an additional Phase II study later this year, we will focus on the heart failure patients most in need of new therapies.”