Theravance Biopharma hypotension drug fails to meet primary goal

[April 05, 2022]  (Reuters) - Theravance Biopharma Inc said on Monday its experimental drug to treat a form of low-blood pressure failed to show significant improvement in the overall patient population of a late-stage study, but showed a benefit in patients with a rare neurological disorder.

The drug, ampreloxetine, was being tested in patients with symptomatic neurogenic orthostatic hypotension (nOH), a rare disorder where there is a sustained fall in systolic blood pressure within three minutes of standing.

The company said that analyses for overall patients showed that while those receiving the drug had a 40% reduction in odds that the treatment may fail compared to placebo, the result was not statistically significant.

The entire group included patients with Parkinson's disease and a neurodegenerative disorder of a peripheral nervous system, as well as those with multiple system atrophy (MSA), a rare neurological disorder affecting the body's involuntary functions.
 

Further analysis of subgroups showed MSA patients benefited most from the use of the drug, with a 72% reduction in odds that the treatment may fail.

While the same benefit was not apparent in patients with Parkinson's or the neurodegenerative disorder called pure autonomic failure, Theravance said it continues to analyze the data.

"Given the clear unmet need for MSA patients suffering from symptomatic nOH, we are engaging potential partners and planning health authority interactions to determine a path forward in hopes of expediting ampreloxetine as a possible treatment option for people with MSA," Theravance Chief Executive Officer Rick Winningham said in a statement.

The company said the drug was well-tolerated, with no new safety signals identified.

(Reporting by Leroy Leo in Bengaluru; Editing by Maju Samuel)

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