Theravance Biopharma is restructuring its R&D organisation and cutting its workforce by approximately half after its rare disease blood pressure drug failed to meet the primary endpoint in a Phase III study.
In the CYPRESS study (NCT05696717), ampreloxetine failed to improve Orthostatic Hypotension Symptom Assessment (OHSA) composite score after eight weeks in patients with neurogenic orthostatic hypotension (nOH) due to multiple system atrophy (MSA).
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Similar trends were observed in the secondary endpoints. Change in blood pressure, heart rate and norepinephrine levels confirmed a consistent pressor effect and reaffirmed ampreloxetine’s biological activity. The drug was generally well tolerated, with safety findings consistent with prior studies, including no signal of worsening of supine hypertension.
CEO of Theravance, Rick Winningham, said: “We are disappointed that ampreloxetine did not meet the primary endpoint in the CYPRESS study. These results are particularly disheartening for the patients who are suffering from this rare disease and were hoping for a new treatment option and for the employees who dedicated years of work to this programme.”
Due to the study failure, Theravance will discontinue the ampreloxetine programme.
Company to close R&D branch
The company will now wind down its R&D division and significantly reduce the general and administrative function amid a restructuring.
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By GlobalDataThe restructuring is expected to impact approximately 50% of the overall workforce over the next two quarters and is set to cost approximately $5m to $7m in one-time cash severance costs. However, it is projected to reduce operating expenses by approximately $70m.
As a result of winding down its R&D arm, the company’s value will come from two partnered, marketed assets. This includes the companies 35% interest in Yupelri (revefenacin), a once-daily, nebulised long-acting muscarinic antagonist (LAMA) for chronic obstructive pulmonary disease (COPD), which was developed in partnership with Viatris. The company predicts it will receive between $60m and $70m of annual cash flow for the drug.
Theravance will also gain revenue from its other asset, Trelegy (fluticasone furoate/umeclidinium/vilanterol), a once-daily, prescription dry-powder inhaler combining an ICS, LAMA, and LABA, also for COPD, which was developed with GSK.
Theravance Bio’s Nasdaq-listed shares fell 26.33% on 3 March following the announcement, declining from a $18.95 close on 2 March to $13.96 at close on 3 March.
The ampreloxetine study is the second time the drug has failed to show benefit in a Phase III trial. In 2021, the candidate was no better than placebo in a broader set of nOH patients, which triggered Theravance to look at the MSA subgroup.
In 2023, the company also dropped its inhaled Janus kinase (JAK) inhibitor candidate nezulcitinib after it failed to show efficacy in a Phase II trial in acute and chronic lung inflammation and fibrotic disease.
