“We are excited to confirm that PL-3994 has the profile of biological activity in humans that was predicted from animal model data and that it was safe and well tolerated,” stated Dr. Trevor Hallam who is the Palatin’s Executive Vice President for Research and Development.
For treatment of acute congestive heart failure, a long-acting natriuretic peptide receptor A is under development. The Phase I trial was a single ascending dose study in 26 healthy volunteers who received the medication or placebo subcutaneously. The trial consists of the evaluations such as safety, tolerability, and pharmaco-kinetics. The evaluations also include several pharmaco-dynamic endpoints that consist of levels of a natural messenger nucleotide, ‘cyclic guanosine monophosphate (CGMP)’.
The primary endpoint of the study that is successfully achieved by the dosing is the reduction in systemic blood pressure. Not even one of the volunteers did experience a serious or adverse effect of the study by receiving a dose of medication. After the single sub-cutaneous dose all of the volunteers were observed for several hours with increase in plasma CGMP levels, increased urination or diuresis and increased sodium excretion or natriuresis. The data analysis is going on and when the analysis is complete, it will be submitted for presentation.
