Octapharma has begun enrolling patients in its Phase II/III trial of GAM-27 for the treatment of relapsing multiple sclerosis (RMS). Through intravenous administration of immunoglobulin (Octagam 5%), the study seeks to support the overall clinical benefit of a lower annualized relapse rate in patients where first-line treatment is not suitable.

This randomized, active-controlled study aims to confirm preliminary results that suggested it is possible to identify potential responders to treatment with Octagam 5%. Using a combination of functional genomic and protein expression tests, a special assay panel — Heidelberg Assay Panel (HAP) — was developed that could potentially stratify patients into predicted responders or non-responders. These laboratory-based tests require a simple blood sample from the patient.

A subgroup of patients with RMS experience disabling side effects with current first-line treatments, which can result in an inability to comply with their treatment protocol, or do not benefit from this treatment. By identifying predicted responders it is believed that the known and favorable tolerability profile of Octagam 5% could improve the quality of life for this group of patients.

The study will recruit 216 patients with early relapsing MS at approximately 35 European sites in several countries, including Austria, Bulgaria, Germany, Hungary and Russia. The patients will be treated for a 24-month period with expected trial completion by the end of 2016.