Theravance Biopharma has dosed the first patient in a Phase III clinical trial investigating the efficacy, safety and tolerability of ampreloxetine (TD-9855) for the treatment of patients with symptomatic neurogenic orthostatic hypotension (nOH).
Ampreloxetine is currently being studied as a once-daily norepinephrine reuptake inhibitor (NRI) for use in the treatment of patients with symptomatic nOH, a rare disorder characterised by sustained orthostatic fall in systolic blood pressure (SBP) or diastolic blood pressure (DBP) within three minutes of standing.
Theravance aims to enrol around 188 patients for the four-week, multi-centre, randomised, double-blind, placebo-controlled, parallel-group trial.
The trial will include patients with symptomatic nOH caused by primary autonomic failure related to multiple system atrophy (MSA), Parkinson's disease (PD) and pure autonomic failure (PAF).
During the trial, randomised patients will receive a single dose of 10mg ampreloxetine or placebo once daily for four weeks.
The trial’s primary objective is change from baseline in dizziness severity as assessed by the Orthostatic Hypotension Symptom Assessment (OHSA) at four weeks for ampreloxetine against placebo.
It will also investigate additional efficacy assessments, safety and tolerability measures.
Theravance Biopharma chief medical officer Brett Haumann said: “Given the limitations of currently available therapeutic options, we recognise a significant opportunity exists for a potentially safe and durable treatment for nOH.
“Positive four-week results achieved in our Phase II study provide the basis for advancing ampreloxetine into this registrational Phase III programme.
“We are pleased to begin 2019 with this milestone, and in the near term we also anticipate dosing the first patient in the Phase IIb/III study of TD-1473, our gut-selective JAK inhibitor, in patients with ulcerative colitis.”