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Drug Delivery

Theravance lays off most of workforce after trial failure

Ampreloxetine was ineffective in alleviating neurogenic orthostatic hypotension in Phase 3 trials

by Megha Satyanarayana
September 16, 2021

The structure of ampreloxetine.
Ampreloxetine

Theravance Biopharma announced Wednesday it will lay off about 75% of its workforce as part of a decision to restructure after a failed Phase 3 trial of ampreloxetine as a treatment for a blood pressure disorder.

The layoffs will affect 270 people at the firm, with the majority of reductions to be completed by November. Theravance specializes in tissue- and organ-specific small-molecule treatments for inflammatory diseases. It has two inhalable treatments on the market for chronic obstructive pulmonary disease, Yupelri and Trelegy.

CEO Rick E. Winningham said Theravance will stick to its respiratory disease program and drop its Crohn’s disease program in an effort to reduce its overall expenses to $165 million in 2022. This includes cuts in its R&D budget from about $180 million in 2021 to $55 million in 2022. He said the restructuring will make the company profitable again by the second half of 2022.

“I am confident the totality of these actions will allow us to continue making medicines aimed at improving the lives of patients suffering from serious respiratory illness, while at the same time creating value for shareholders,” Winningham said on a conference call early Wednesday.

He also said the company will likely end current ampreloxetine trials after the Phase 3 trial did not meet its primary endpoint. The trial enrolled 258 people, who were tracked for 22 weeks to see if ampreloxetine alleviates neurogenic orthostatic hypotension, a blood pressure regulation problem associated with neurodegenerative and metabolic diseases. People with the disease tend to fall when they stand up because they cannot quickly regulate their blood pressure.

Ampreloxetine prevents norephinephrine from being taken up by cells by blocking the transport proteins that ferry it. Increasing the concentration of norephinephrine between cells was proposed to help alleviate the blood pressure regulation issue in neurogenic orthostatic hypotension.

The company said it will focus on advanced drug candidates like the janus kinase inhibitor (JAK) nezulcitinib for lung injury, including the prevention of lung transplant rejection.

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