Theravance Biopharma Presents Analyses Of Previous Phase 3 Program Evaluating Ampreloxetine For Treatment Of Symptomatic nOH At International MSA Congress

Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ:TBPH) today announced presentation of analyses of its previous Phase 3 program evaluating ampreloxetine, an investigational medicine for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) at the International MSA Congress, taking place May 9-11 in Boston, Massachusetts.

A subgroup analysis selected as a platform presentation focused on patients with Multiple System Atrophy (MSA) in the REDWOOD 0170 study (NCT03829657), an international phase 3, placebo-controlled, double-blind, randomized withdrawal trial, designed to demonstrate clinical worsening in those assigned to placebo. This analysis concluded:

• Patients with MSA showed clinically meaningful improvement in their nOH symptoms as measured by the OH Symptom Assessment (OHSA) composite score after 16 weeks of open-label treatment with ampreloxetine. After week 6 of randomization, symptoms remained stable in the ampreloxetine group and worsened in the placebo group.
• Ampreloxetine treatment was associated with an improvement in functional activities, such as standing or walking for a short time, which was lost after withdrawal to placebo.
• The clinical, cardiovascular and neuroendocrine profile of ampreloxetine showed target engagement of residual peripheral autonomic neurons and a sustained standing blood pressure effect, which is consistent with the profile of a selective norepinephrine reuptake inhibitor.

An additional analysis from Study 0169 (NCT03750552) presented at the Congress showed that despite treatment with available nOH medications, patients with MSA had the highest nOH symptom burden on entry, which highlights the substantial unmet need for better nOH therapies in this population.

Results from these studies were supportive of the current registrational study in patients with nOH and MSA that is currently ongoing (CYPRESS, NCT05696717).