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Theravance Biopharma Reports New Data from Phase 2 Study of Ampreloxetine (TD-9855) in Presentation at 2019 International Association of Parkinsonism and Related Disorders (IAPRD) World Congress
DUBLIN, June 18, 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, June 18, 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 a poster presentation at the 2019 International Association of Parkinsonism and Related Disorders (IAPRD) World Congress. New data demonstrated that the study's previously reported improvements in nOH symptom severity following four weeks of treatment were sustained until the completion of 20 weeks of ampreloxetine therapy. Following discontinuation of treatment at the end of 20 weeks, these improvements in patients' nOH symptoms deteriorated, with severity returning to baseline levels. The 2019 IAPRD World Congress is being held June 16-19, 2019 in Montreal, Canada. \n\n \nAmpreloxetine is an investigational, once-daily 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 IAPRD 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. As previously reported, 16 subjects completed the first four weeks of treatment and demonstrated evidence of improved nOH symptom severity by the end of four weeks of treatment. The mean reduction in symptom severity in these 16 subjects was 2.4 points at four weeks, as measured by Orthostatic Hypotension Symptom Assessment (OHSA) Question #1 (OHSA#1, a measure of dizzine...