Apitope 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.