Apitope, the drug discovery and development company focused on treating the underlying cause of autoimmune diseases, has announced completion with positive results of its second Phase I clinical trial of ATX-MS-1467. Examination of the MRI results (new Gd and total Gd enhancing lesions) demonstrated a significant decrease in the number of contrast-enhancing brain lesions (CEL) in patients with relapsing multiple sclerosis treated by intradermal injection of ATX-MS-1467. The same effect was not seen in the subcutaneously dosed group. These encouraging results will now need confirmation in appropriate Phase II trials.
Completion of the study together with these positive MRI-based data allows Merck Serono, the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, with whom Apitope is developing ATX-MS-1467, to develop plans for Phase II onwards.
Dr. Keith Martin, CEO of Apitope stated: "We are pleased to have successfully completed a challenging clinical trial with positive results. The results of this trial in patients with relapsing MS continue to build on the positive data from our first study and provide further clinical support for the Apitope approach to the treatment of serious autoimmune conditions."
Prof David Wraith, Apitope's CSO and Founder added: "Antigen specific immunotherapy is designed to correct the immunological imbalance that causes autoimmune disease without inducing the non-specific immune suppression that so frequently causes unacceptable side effects. Up to now this approach has been shown to be highly effective in experimental models but has been slow to progress into the clinic. It is, therefore, a major step forward that the approach is proving to be so well tolerated with early signs of potential efficacy, as evidenced by the results of Apitope's two clinical trials in MS."
ATX-MS-1467 is a potentially 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, restoring immunological balance.
It 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 completed to assess the safety of ATX-MS-1467, as well as biological parameters, in a total of 43 patients with relapsing MS.
The primary endpoint of the recently completed trial was safety and tolerability, as assessed by adverse effects and MRI scans, as well as secondary endpoints to identify early signs of efficacy. Review of the MRI data showed a significant decrease in new lesions; an early indicator of potential efficacy.
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 parties, Apitope was responsible for this Phase I clinical trial of ATX-MS-1467. Merck Serono will be responsible for all development activities going forward from the beginning of Phase II clinical trials.
About ATX-MS-1467
ATX-MS-1467 consists of four synthetic peptides that mimic naturally occurring peptides derived from human Myelin Basic Protein (MBP), a key autoantigen in multiple sclerosis. ATX-MS-1467 has been designed from naturally occurring MBP fragments and is intended to selectively inhibit the immune system's harmful attack on the protective myelin sheath surrounding the nervous cells while preserving the normal immune response to any harmful antigens, such as infections.
About MS
MS is a chronic, inflammatory condition of the nervous system and is the most common, non-traumatic, disabling neurological disease in young adults, with most sufferers developing the disease between the ages of 20 and 40 years. The World Health Organization estimates that up to 2.5 million people suffer from MS worldwide with women affected 1.8 times more frequently than men. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination.
MS develops as a result of damage to the myelin sheath of the nerves which interferes with their normal function and leads to loss of muscle control. MS can follow various patterns of disease progression. Most patients initially have a relapsing form of the condition, which is characterized by unpredictable relapses followed by periods of months to years of remission. Approximately two-thirds of patients with relapsing disease go on to develop secondary progressive MS, in which progressive neurologic decline continues between acute attacks without any periods of remission.