Glaxo (GSK) Halts Enrollment in GSK '052 Phase 2b Following Recent Discovery (ANAC)
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Anacor Pharmaceuticals (Nasdaq: ANAC) announced today that its partner GlaxoSmithKline (NYSE: GSK) has voluntarily paused enrollment in its current clinical trials of GSK2251052 (GSK ‘052) due to a recently identified microbiological finding in a small number of patients in the Phase 2b trial of GSK ‘052 for the treatment of complicated urinary tract infections (cUTI). GSK is in the process of obtaining additional information in order to better understand the data, but will not resume the trials until it has concluded its investigation. Upon completion of the review, GSK will determine next steps regarding the future development of GSK ‘052.
In addition to the Phase 2b study in cUTI, GSK ‘052 is currently being evaluated in a Phase 2b study in complicated intra-abdominal infections (cIAI) and two Phase 1 studies in healthy volunteers. While the microbiological finding seen in the cUTI study is not related to the safety of GSK ‘052, the potential to negatively impact efficacy led GSK to voluntarily suspend enrollment in all four studies. Subjects who are currently enrolled in the ongoing studies may continue at the discretion of the investigator.
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In addition to the Phase 2b study in cUTI, GSK ‘052 is currently being evaluated in a Phase 2b study in complicated intra-abdominal infections (cIAI) and two Phase 1 studies in healthy volunteers. While the microbiological finding seen in the cUTI study is not related to the safety of GSK ‘052, the potential to negatively impact efficacy led GSK to voluntarily suspend enrollment in all four studies. Subjects who are currently enrolled in the ongoing studies may continue at the discretion of the investigator.
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