Theravance axes staff as lead pipeline drug flunks phase 3 trial

Theravance has been forced to downsize its business after its lead pipeline drug ampreloxatine missed the mark in a phase 3 trial, cutting 75% of its workforce.

The Irish-American biopharma said this morning that ampreloxetine did not meet its objectives in a trial involving patients with symptomatic neurogenic orthostatic hypotension (nOH) – a rare condition in which the body loses its ability to regulate blood pressure properly.

Faced with the disappointment, Theravance has said it will shed 270 staff by the end of February, and switch its attention to respiratory disease pipeline. It will however complete a second phase 3 study of ampreloxatine in nOH, and a phase 2 trial of TD-1473 – a gut-selective JAK inhibitor – in ulcerative colitis.

The move is expected to slash costs by $165 million next year, which Theravance said would allow it to become cashflow-positive in the second half of 2022.

The company's chief executive, Rick Winningham, said that the outcome of the ampreloxatine study was "not…what we had hoped to achieve,  especially given the clear unmet need for patients suffering from symptomatic nOH."

Severely affected patients are unable to stand for more than a few seconds because of a decrease in blood pressure, according to the company.

Looking forward, Theravance's respiratory portfolio is headed by Viatris-partnered Yulperi (revefenacin), a nebulised long-acting muscarinic antagonist (LAMA) for asthma and chronic obstructive pulmonary disease (COPD).

The drug has been approved in the US since 2019 but faces a very crowded market, although Theravance maintains that it could in time become a $400 million product, assuming ongoing studies aimed at extending its product label are successful.

Following after are wholly-owned lung-selective JAK inhibitors nezulcitinib (TD-0903) and TD-8236 which are in phase 2 trials for inflammatory lung diseases.

The company also has a royalty interest in GlaxoSmithKline's triple therapy for COPD – Trelegy (fluticasone furoate/umeclidinium bromide/vilanterol) – which it says has the potential to become a $3 billion product. Trelegy made a little under $750 million in the first half of this year.

Shares in Theravance were down almost 39% in pre-market trading at the time of writing.