Japan’s Sosei has halted development of its stress urinary incontinence drug SOU-001 after struggling to recruit patients into clinical trials of the drug.
Sosei said it had started Phase IIa clinical trials with patients suffering from incontinence in June 2005 but found recruitment much more difficult than anticipated. As a result, the company reviewed the commercial prospects of the drug and decided to discontinue the project.
“Based on an ongoing review of the product pipeline, Sosei decided SOU-001 would no longer be a priority project for internal development resources,” it said in a statement.
Sosei develops new products by taking established drugs and developing them for new indications, a process it refers to as ‘re-profiling’, and also licenses drugs from overseas firms for local development and marketing in Japan. SOU-001 was an example of the former approach, having been developed up to Phase II by a Japanese drugmaker as a cardiovascular drug.
In June 2004, the UK’s Medicines and Healthcare products Regulatory Agency approved a Phase I clinical trial of an oral formulation of SOU-001, and Sosei received approval to initiate Phase II clinical trial in June 2005.