Octapharma announces new study of IVIG in chronic inflammatory demyelinating polyradiculoneuropathy

Octapharma AG today announced the imminent start of the biggest ever study of an intravenous immunoglobulin preparation (IVIG) in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

“Octapharma's stated aim is not to develop just another IVIG brand but to invest extensive time and preclinical resources to ensure that the new IVIG will offer outstanding features, representing tangible added value for the patient and care giver, such as exceptional tolerability”

The double-blind, placebo-controlled, randomised, multicentre, adaptive, two-stage Phase 2/3 dose-finding study will investigate the efficacy and safety of Octapharma's novel 10% intravenous immunoglobulin in the treatment of CIDP and, together with results from additional on-going and upcoming studies, will support its regulatory filing in Europe and the US.

Commenting on the start of the study, Kim Björnstrup, Vice Chairman of Octapharma Group said, "The development of our novel 10% IVIG is part of our ongoing commitment to invest in the development of protein based immunotherapies and in particular in IgG preparations. For 25 years, our cutting-edge research program has sought to develop new biological entities tailored specifically around the needs of clinicians and patients - delivering improved quality of life for patients and ease of delivery and management for hospitals."

"Octapharma's stated aim is not to develop just another IVIG brand but to invest extensive time and preclinical resources to ensure that the new IVIG will offer outstanding features, representing tangible added value for the patient and care giver, such as exceptional tolerability," added Kim Björnstrup.

The development of this completely new high purity IVIG builds upon Octapharma's experience in the area of immunoglobulin products. Octapharma's current leading IVIG brand has been introduced to the market in 1995 and is currently registered in about 60 countries, including the EU and the US.

"Octapharma's new 10% IVIG will be a step forward in the evolution of IVIG products. Regarding the development of the product, Octapharma has looked to optimise the characteristics of the product for improved patient outcomes, such as high tolerability even at high infusion rates. Pre-clinical studies and data from an on-going clinical trial in primary immunodeficiency (PI) have confirmed that a favourable tolerability profile may be expected" commented Dr Stefan Haag, Head of Octapharma's International Immunotherapy Business Unit.

The Phase II/III study in CIDP represents another element in a series of studies to investigate Octapharma's new 10% IVIG for a range of neurologic and haematological conditions including immune thrombocytopenic purpura (ITP), Guillain-Barré syndrome (GBS), Kawasaki disease and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).