Theravance to recruit 120 trial sites for Phase III trial in neurogenic orthostatic hypotension

GlobalData Healthcare 21st October 2019 (Last Updated October 23rd, 2019 10:43)

neurogenic orthostatic hypotension is a rare subtype of orthostatic hypotension caused by underlying neurologic disorders that affect a specific part of the autonomic nervous system.

Theravance to recruit 120 trial sites for Phase III trial in neurogenic orthostatic hypotension

Theravance Biopharma’s Phase III ampreloxetine in symptomatic neurogenic orthostatic hypotension (nOH) with primary autonomic failure plans to have 120 trial sites, said a source familiar with the trial on the sidelines of the International Congress of Parkinson’s Disease and Movement Disorders in Nice, France. 

Thirty of those sites will be in the US, 70 in the EU and the remainder in the rest of the world (ROW), the source said.

NOH is a rare subtype of orthostatic hypotension caused by underlying neurologic disorders that affect a specific part of the autonomic nervous system.

As per ClinicalTrials.gov, the 188-patient Phase III SEQUOIA (NCT03750552) study has 20 sites, one Canadian site, two Danish sites, three Estonian sites, one French, two Hungarian, five Spanish and five UK sites listed. The source said as of about three weeks to a month ago, only about three to five US sites are actively recruiting, and other US sites are still in the onboarding process. The company announced in a 1 January press release that it had enrolled its first patient. The trial has a 1 September 2020 completion date.

The EU investigators for SEQUOIA had a meeting for the trial today at the conference, said Jennifer Coppins, Theravance’s associate director, Clinical Trial Liaison and Global Development Operations.

Theravance is working with global CRO IQVIA, as well as other regional CROs for the ongoing Phase III trial, Coppins said. The CROs are involved in the recruitment and patient care in North America (the US and Canada) and EU sites, and there are ongoing discussions to add sites in South America and South Korea too, she said.

Theravance had presented Phase II data (NCT02705755) at the conference, which showed positive data of 21 patients in the orthostatic hypotension symptom assessment (OHSA) efficacy endpoint in the single-blinded study. OHSA is the primary endpoint in SEQUOIA and also in the follow-on 22-week, 258-patient extension REDWOOD (NCT03829657) study for those who completed SEQUOIA, Coppins said.

Analysts project sales of more than $500m for ampreloxetine, and Theravance has a market capitalisation of $1.28bn.

by Shuan Sim in Nice, France

Shuan Sim is a Senior Reporter for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.