Theravance Biopharma Inc TBPH revealed results from the second Phase 3 study assessing ampreloxetine compared to placebo for symptomatic nOH.
- Neurogenic orthostatic hypotension (nOH) is a rare disorder defined as a sustained orthostatic fall in blood pressure within three minutes of standing.
- The primary endpoint was treatment failure at week 6 of the randomized withdrawal period.
- The primary endpoint was not statistically significant for the overall population of patients, including patients with Parkinson's disease (PD), pure autonomic failure (PAF), and MSA.
- The odds ratio suggests that patients receiving ampreloxetine had a 40% reduction in the odds of treatment failure compared to placebo.
- Also See: Theravance Biopharma Pulls Plug On Izencitinib Crohn's Disease Trial.
- The prespecified subgroup analysis suggests the benefit seen in patients receiving ampreloxetine was primarily driven by multiple system atrophy (MSA) patients (n=40).
- An odds ratio of 0.28 was observed in MSA patients indicating a 72% reduction in the odds of treatment failure with ampreloxetine compared to placebo.
- Patients withdrawn to placebo had a clinically relevant decrease in standing blood pressure.
- While the same benefit was not apparent in patients with PD or PAF, the Company continues to analyze the data.
- There was no indication of worsening of supine hypertension throughout the study based on 24-hour monitoring.
- Data suggest that ampreloxetine was well-tolerated, and no new safety signals were identified.
- Price Action: TBPH shares are up 3.05% at $9.79 during the premarket session on the last check Tuesday.
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