Baxter International has announced Phase III clinical data investigating the safety and efficacy of Gammagard Liquid 10%, intended for the treatment of multifocal motor neuropathy (MMN).
Approved by the US Food and Drug Administration (FDA), Gammagard Liquid is indicated as a replacement therapy for primary humoral immunodeficiency in adult and paediatric patients two years of age or older.
The Phase III randomised double-blind placebo-controlled cross-over multi-centre study assessed 44 patients with MMN to determine whether Gammagard Liquid was superior to placebo in preserving muscle grip strength and preventing progression of disability.
In the study, Gammagard Liquid met its two primary efficacy endpoints, reporting a 3.75% increase in mean grip strength of affected hand during treatment, as compared to a 31.38% decrease in mean grip strength with placebo administration.
The study also found that a greater proportion of patients who received placebo experienced progressive disability, as assessed by the Guy's Neurological Disability Score compared to those receiving Gammagard Liquid.
Baxter BioScience business global research and development vice president Hartmut Ehrlich said MMN is a progressive disease and that the development programme helped evaluate the potential for new uses for Gammagard Liquid.
"If approved by the regulatory authorities, Gammagard Liquid will become the first immunoglobulin treatment available for patients with MMN in the United States,'' Ehrlich added.
Gammagard Liquid is marketed under the trade name Kiovi outside the US and Canada, and the company filed a supplemental biologics license application with the FDA seeking an indication for Gammagard Liquid to include MMN in December 2011.
Baxter International develops, manufactures and markets products against haemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions.