Theravance Biopharma doses nOH patients in Phase 3 testing investigational inhibitor ampreloxetine

Theravance Biopharma has started dosing patients with symptomatic neurogenic orthostatic hypotension (nOH) to test its investigational neropinephrine reuptake inhibitor ampreloxetine (TD-9855), in a registrational Phase 3 clinical trial.

A dozen less than 200 patients with symptomatic nOH caused by primary autonomic failure associated with multiple system atrophy (MSA), Parkinson’s disease (PD) and pure autonomic failure (PAF), will be randomized to receive a single 10 mg dose of ampreloxetine or placebo once daily for four weeks.

Theravance said that the primary endpoint of the study is change from baseline in dizziness severity, as measured by Orthostatic Hypotension Symptom Assessment (OHSA) Question #1 (OHSA #1, a measure of dizziness, lightheadedness or the sensation of being about to black out) at four weeks for ampreloxetine as compared to placebo.

Brett Haumann, chief medical officer at Theravance Biopharma, said: “Given the limitations of currently available therapeutic options, we recognize a significant opportunity exists for a potentially safe and durable treatment for nOH.

He said that in the near term the company expects to start dosing the first patient to test its gut-selective JAK inhibitor, in patients with ulcerative colitis, in the Phase 2b/3 study of TD-1473.