Apitope, a drug discovery and development company founded by Professor David Wraith in the School of Cellular and Molecular Medicine, completed the second Phase I clinical trial to assess the safety of its peptide therapeutic ‘ATX-MS-1467’, as well as biological parameters, in a total of 43 patients with relapsing MS. Review of the MRI data showed a significant decrease in new lesions; an early indicator of potential efficacy.
Dr Keith Martin, CEO of Apitope, said: “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.”
Professor 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 nonspecific 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.”
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.
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.
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.
Apitope International NV, based in Belgium and the UK, is a world-class drug developer of immunotherapies for the treatment of autoimmune and allergic diseases, including multiple sclerosis, factor VIII intolerance, uveitis and Graves’ disease. The Company has a patented discovery platform which enables selection of disease-modifying peptide therapies for the autoimmune/allergic disease of interest; and has already generated a pipeline of seven programmes in clinical and preclinical development, of which the lead programme in multiple sclerosis is partnered with Merck Serono. The discovery engine selects Apitopes™ – Antigen Processing Independent epiTOPES. Apitopes are soluble, synthetic peptides from the human sequence which can selectively suppress abnormal immune responses and reinstate the normal immune balance. Stakeholders in the Company include the Wellcome Trust, LRM, Vesalius Biocapital and the US MS charity, Fast Forward. For more information on the Company, please visit: www.apitope.com.