Beleaguered Theravance logs head-to-head trial loss for Yupelri against Boehringer's Spiriva

When Theravance called it quits on a phase 2 JAK inhibitor program last February, the South San Francisco and Dublin-based biopharma company put the majority of its chips on a head-to-head trial pitting its Viatris-partnered bronchodilator Yupelri against Boehringer Ingelheim’s Spiriva in chronic obstructive pulmonary disease (COPD).

Nearly a year later, that study has played out, though perhaps not in the way Theravance had hoped.

In the phase 4 PIFR-2 study, Theravance and Viatris’ Yupelri, delivered via standard jet nebulizer, failed to demonstrate greater lung function improvement versus Spiriva delivered by a dry powder inhaler, Theravance said Friday.

Despite the trial miss, Theravance remains optimistic about the opportunities in store for Yupelri moving forward, the company’s CEO, Rick Winningham, said in a statement.

Theravance plans to roll out additional details from the PIFR-2 study following additional data analyses, he added.

When it comes to Yupelri revenue, Pfizer and Mylan’s generics spinout Viatris records total net sales for the inhalable medicine, of which Theravance is entitled to a 35% share of profits and losses.

For all of 2022, Yupelri brought home total sales of $202.1 million, up from the $161.9 million it garnered the year before. Theravance and Viatris have yet to publish full-year financial results for 2023.

Theravance has been heavily focused on completing the PIFR-2 head-to-head trial ever since it cut its inhaled Janus kinase (JAK) inhibitor program nezulcitinib back in February of 2023. The therapy had been in phase 2 development for acute and chronic lung inflammation and fibrotic disease.

At the same time, Theravance said it hoped to prop up a new study of its pipeline asset ampreloxetine, which had previously failed in a late-stage study of a blood pressure disorder in spring of 2022.

Friday’s trial flop marks the latest in a series of blows for the company.

When Theravance announced the termination of its nezulcitinib program last year, the company also disclosed that it had reduced its headcount by 17%. That move came several months after the company laid off 75% of its staff following the phase 3 fail of ampreloxetine in September 2021.