Theravance Biopharma hypotension drug fails to meet primary goal (updated)

Theravance Biopharma

04/04/2022 22:23

(Recasts paragraph 1, adds study details)
    April 4 (Reuters) - Theravance Biopharma Inc  TBPH.O  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)
 ((Leroy.Dsouza@thomsonreuters.com ; Twitter: https://twitter.com/LeroyLeo7;))