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.
Ampreloxetine 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.
The 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.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.