Theravance Biopharma is set to lay off 50% of its workforce, end all R&D work and scrap a blood pressure disorder drug that failed a crucial phase 3 test.
The Dublin- and San Francisco-based biotech had been testing ampreloxetine, a selective norepinephrine reuptake inhibitor (NRI), in a late-stage study of 102 patients with symptomatic neurogenic orthostatic hypotension (nOH), a chronic drop in blood pressure caused by the body’s failure to release enough norepinephrine.
The study missed its primary endpoint, which compared the change in score as measured by the Orthostatic Hypotension Symptom Assessment (OHSA)—an evaluation that includes lightheadedness, dizziness, blurred vision, weakness or fainting when standing—to baseline at Week 8.
In addition to abandoning the ampreloxetine program and halving its headcount, the company announced a “complete wind-down of the R&D organization,” according to a March 3 release. The various changes are expected to reduce the biotech’s cash burn by 60%, or stack up $70 million in savings, through the third quarter of 2026.
While a strategic board committee is considering all options, including a company sale, Theravance will go all-in on Yupelri, its approved nebulized bronchodilator for long-term maintenance treatment of chronic obstructive pulmonary disease (COPD).
Looking ahead, Theravance predicts it will generate $60 to $70 million of annualized cash flow starting in the third quarter of this year from a 35% interest in Viatris-partnered Yulepri and other operations.
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Today’s readout was only the latest clinical setback for Theravance’s ampreloxetine. Back in 2021, the candidate suffered another phase 3 failure, performing no better than placebo in a broader set of nOH patients. Results from that trial prompted Theravance to focus on a prespecified subgroup of 40 nOH patients with multiple system atrophy—today’s results closing the door on ampreloxetine for good.
In fact, 2021 was a tough year for Theravance overall. Over the 12-month stretch, the company laid off three-quarters of its workforce and narrowed its focus to respiratory diseases in the wake of three trial failures.
For its part, ampreloxetine became a top priority for Theravance in 2023 after the biotech dropped its inhaled Janus kinase (JAK) inhibitor program nezulcitinib which was in phase 2 development for acute and chronic lung inflammation and fibrotic disease. That strategic shift included laying off 17% of the biotech’s staff in 2023.
