Theravance Biopharma announced Wednesday that a Phase III study of the experimental drug ampreloxetine for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) missed its primary endpoint. In response to the latest trial failure, the company, whose shares fell as much as 39% on the news, said it will refocus its portfolio and reduce staff numbers by around 75%, or 270 positions.
The study randomised 195 patients with symptomatic nOH to receive the once-daily norepinephrine reuptake inhibitor ampreloxetine or placebo for four weeks. The trial's main goal was improvement in OHSA #1, part of the Orthostatic Hypotension Questionnaire, which assesses the presence of a range of hypotension-related symptoms including dizziness, weakness, problems with vision, fatigue, trouble concentrating and head/neck discomfort.
"These are not the results we had hoped to achieve," remarked CEO Rick Winningham, noting that based on the outcome "we have made the difficult but necessary decision to focus our resources on our most promising respiratory programmes and reduce the size of the organisation." Last month, Theravance announced that izencitinib failed to meet the primary endpoint of a Phase IIb trial of patients with ulcerative colitis. Theravance is developing the oral, gut-selective pan-JAK inhibitor under a partnership with Johnson & Johnson.
Theravance indicated on Wednesday that it will now focus its resources on respiratory therapeutics, including a study in partnership with Viatris intended to generate data supporting label expansion for Yupelri (revefenacin). The company will also invest in its inhaled JAK inhibitor portfolio, particularly nezulcitinib, initially targeting acute lung injury. As such, the drugmaker said that it will halt development of izencitinib in Crohn's disease and the Phase III REDWOOD trial of ampreloxetine.
According to Theravance, the actions are expected to lead to operating expense savings of $165 million in 2022. The company noted that approximately 75% of the workforce reductions will be completed in November, with the remainder set for February next year.
To read more Top Story articles, click here.