Apitope, the European drug discovery and development company focused on treating the underlying cause of autoimmune diseases, today announced completion of recruitment into its second Phase I clinical trial of ATX-MS-1467 in patients with multiple sclerosis (MS). Receipt of the first dose of study treatment by the last patient to be recruited prompted an undisclosed clinical milestone payment from Merck Serono, a division of Merck, Germany, with whom Apitope is developing ATX-MS-1467.
ATX-MS-1467 is a novel treatment that was developed with the aim of working with the immune system to treat the underlying cause of disease rather than just treating the symptoms or suppressing the entire immune system, and thus restore immunological balance.
ATX-MS-1467 has already completed successfully a Phase I clinical trial in six patients with secondary progressive MS (SPMS). Based on these encouraging preliminary results, a second Phase I clinical trial has been implemented to assess the safety of ATX-MS-1467 as well as biological parameters in a group of 40 patients with relapsing MS.
The clinical trial is being carried out at two hospitals in the UK, as well as 12 clinics in Russia. Dosing of ATX-MS-1467 is expected to be complete by the end of 2012.
Dr. Jeremy Chataway, Chief Investigator for the trial, from the National Hospital for Neurology and Neurosurgery in London commented: "ATX-MS-1467 could serve as a treatment option for patients with multiple sclerosis so this is an important step in the current trial."
The primary endpoint of the trial is safety and tolerability, as assessed by adverse effects and MRI scans, while secondary endpoints are designed to provide an insight into the immunological activity of this investigational treatment. A range of doses of ATX-MS-1467 is being administered either intra-dermally or sub-cutaneously once every two weeks for 16 weeks, with a further 24 weeks of post-treatment follow up.
Apitope is developing ATX-MS-1467 with Merck Serono, a market leader in the treatment of MS. Under the terms of the agreement between the two companies, Apitope is responsible for this Phase I clinical trial of ATX-MS-1467. Merck Serono will be responsible for all development activities from the beginning of Phase II clinical trials.
Dr. Keith Martin, CEO of Apitope added: "ATX-MS-1467 is the first therapeutic developed from Apitope's innovative technology platform and we are excited to have reached this key milestone for our partners. We expect that the results of this trial in patients with relapsing MS will build on the positive data from our first study."