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Theravance Biopharma Reports New Data from Phase 2 Study of Ampreloxetine (TD-9855) in Oral Presentation at 32nd European Neurology Congress
DUBLIN, July 22, 2019 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" or the "Company") today reported new data from the
About this update from Theravance Biopharma, Inc.
[{"type":"text","content":"DUBLIN, July 22, 2019 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) (\"Theravance Biopharma\" or the \"Company\") today reported new data from the Company's Phase 2 clinical trial of ampreloxetine (TD-9855) in patients with neurogenic orthostatic hypotension (nOH) in an oral presentation at the 32nd European Neurology Congress. New data demonstrated that patients experienced improvements in their overall nOH symptoms and in their ability to perform daily activities following four weeks of treatment, and that these improvements were sustained until the completion of 20 weeks of ampreloxetine therapy. Following withdrawal of treatment at the end of 20 weeks, patients experienced a worsening in their symptoms and their daily activity scores deteriorated, returning to baseline pre-treatment levels. These results are consistent with previously reported data from the trial demonstrating similarly durable improvements in OHSA #1 (a cardinal measure of nOH severity that assesses the sensation of dizziness, light-headedness or the feeling of being about to black out). The 32nd European Neurology Congress (ENC) is being held July 22-24, 2019 in London.\n\n \nAmpreloxetine is an investigational, once-daily oral norepinephrine reuptake inhibitor (NRI) in development for the treatment of patients with symptomatic nOH. Theravance Biopharma is conducting an ongoing Phase 3 registrational program which includes a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ampreloxetine in symptomatic nOH patients with a four-week endpoint. The registrational program's second study, which is designed to evaluate the durability of response to ampreloxetine, includes a four-month open label phase followed by a six-week randomized, placebo-controlled withdrawal phase. \nThe ENC presentation reported data from the Company's completed Phase 2 clinical study, which evaluated the efficacy, durability and safety of once-daily oral ampreloxetine in patients with nOH. Following the completion of the single ascending dose portion of the study, patients entered the open-label extension phase, which was designed to evaluate improvement in patients' symptoms and impact on blood pressure. \nA total of 21 patients entered the open-label extension phase of the study. 16 subjects completed the first four weeks of treatmen...