08.01.18
Theravance Biopharma announced positive four-week results from a Phase 2 clinical trial of TD-9855, an investigational, once-daily norepinephrine and serotonin reuptake inhibitor (NSRI) in development for the treatment of patients with symptomatic neurogenic orthostatic hypotension (nOH).
Top-line results from the study included durable improvements in patients' disease symptom severity after four weeks of treatment with TD-9855, as measured by Orthostatic Hypotension Symptom Assessment Question #1 (OHSA #1). OHSA #1 is a measure of dizziness, lightheadedness, or the sensation of being about to black out. Patients treated in the extension phase of the study showed a mean symptom improvement of 2.4 points at four weeks. Importantly, mean symptom improvement was greatest (3.8 points) in nOH patients who reported dizziness symptoms (OHSA #1 > 4) at baseline, a pre-defined regulatory and clinical threshold that will be used to enroll patients in Phase 3.
Additionally, TD-9855 consistently increased systolic blood pressure (SBP), including clinically meaningful increases in standing SBP at the three-minute assessment at all time points on all weekly clinic visits. There were no drug-related serious adverse events reported, and TD-9855 was generally well tolerated in the study. Theravance Biopharma has also concluded its discussions with the U.S. Food and Drug Administration ( FDA ) on the design of a pivotal Phase 3 registrational program and plans to initiate the program in late 2018 or early 2019.
"Demonstrating improvements in dizziness, one of the key nOH symptoms, coupled with sustained blood pressure benefits up to four weeks, provide very encouraging evidence of the important impact TD-9855 can have on patients afflicted with the condition," said Brett Haumann, MD, chief medical officer of Theravance Biopharma. "We believe the durability of effect observed in patients on active therapy may prove to be a differentiating feature for TD-9855, and data collected in this multi-part clinical trial provide us confidence to advance TD-9855 into a pivotal Phase 3 clinical program.”
"Demonstrating improvements in dizziness, one of the key nOH symptoms, coupled with sustained blood pressure benefits up to four weeks, provide very encouraging evidence of the important impact TD-9855 can have on patients afflicted with the condition," said Brett Haumann, MD, chief medical officer of Theravance Biopharma. "We believe the durability of effect observed in patients on active therapy may prove to be a differentiating feature for TD-9855, and data collected in this multi-part clinical trial provide us confidence to advance TD-9855 into a pivotal Phase 3 clinical program.”
