Baxter initiates phase III Kiovig trial

Baxter has announced the start of a phase III clinical trial of Kiovig [Immune Globulin Intravenous (IGIV)] as a treatment for mild to moderate Alzheimer’s disease.

The decision to evaluate the drug, which is also known as Gammagard Liquid, follows a review of a new drug application made to the US Food and Drug Administration.

Baxter said this trial is forecast to be the first of two pivotal phase III studies which will be necessary in order to file for regulatory approval for the compound in this indication.

The study will be a prospective, 18-month, randomised, placebo-controlled, two dose-arm, double-blind, parallel trial involving 360 patients of both genders aged 50 to 89.

Efficacy of Kiovig will be measured with the primary endpoints of cognitive outcomes using the ADAS-Cog scale and global clinical outcome using the ADCS-CGIC rating.

“Secondary endpoints to be assessed at 18 months include behavioural, functional and quality of life outcome measures,” Baxter said.

It added that other secondary endpoints will include a number of imaging, plasma and cerebrospinal fluid biomarkers to assess the response to therapy and progression of the disease.

In April 2008, Baxter International announced that Kiovig helped to improve cognitive functions in patients while reducing or removing the “building blocks” of Alzheimer’s disease in patients.