The Essential Tremor – 2 (POET-2) program is a two-part registration program, the first part of which is a clinical study to enroll up to 90 subjects with tremor in seven US medical centers. The objective is to acquire the set of Altropane images which will be used to train the expert readers, a customary practice for clinical trials of molecular imaging agents.
The second part of the planned POET-2 program will involve two concurrent, replicate, multi-center Phase III trials using the optimized Altropane imaging protocol Alseres developed for commercial use.
Mark Hurtt, chief medical officer of Alseres, said: “If these trials are successful and the drug is approved, we believe that Altropane could be a highly-selective central nervous system diagnostic molecular imaging agent – and a valuable tool to help clinicians make better, more-accurate diagnoses.”