Apitope Regains Full Rights to Potential MS Therapy, ATX-MS-1467

Patricia Silva, PhD avatar

by Patricia Silva, PhD |

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ApitopeĀ andĀ Merck KGaAĀ announced that they have entered into an exclusive agreement regardingĀ ATX-MS-1467, a potential disease-modifying therapy for Ā multiple sclerosis (MS).

Under itsĀ terms, Apitope will regain full global rights over ATX-MS-1467, as well as allĀ clinical data related to the compound. In 2009, the companyĀ grantedĀ exclusive global rights toĀ Merck KGaA to develop and commercialize the treatment, nowĀ being evaluated in a nearly completeĀ Phase 2a clinical trial (NCT01973491) in relapsing MS patients.

In MS, the bodyā€™s immune cellsĀ mistakenly attack theĀ myelin sheathsĀ that surround nerve cell fibers. ATX-MS-1467 is a potential disease-modifying agent with anĀ immune-tolerating action. It consists of four short peptides that are derived from the myelin basic protein, and is designed to reduce myelin attacks by ā€˜switching offā€™ the damaging autoimmune response.

“We believe ATX-MS-1467 has enormous potential for treating MS patients. We are pleased to be regaining the rights to the compound, as well as the clinical data. This will provide us with greater flexibility and control in the clinical development of ATX-MS-1467, Dr. Keith Martin, CEO of Apitope, said in aĀ press release.Ā “We are now able to pursue new business collaborations to enable the further development of this promising treatment. We appreciate the efforts made by the Merck KGaA, Darmstadt,Ā Germany-team members in advancing this programme to date.”

ATX-MS-1467 has successfully completed two Phase 1Ā clinical trials.Ā The first included six patients with secondary progressive MS (SPMS), and the second 43 patients with relapsing MS. Both studies assessed the drugā€™s safety and biological disease parameters. Analysis of the magnetic resonance imaging (MRI) results (the studies’ primary endpoint) foundĀ a 78 percent decrease in contrast-enhancing brain lesions in relapsing MS patients treated with an intradermal injection of ATX-MS-1467.

The more recent Phase 2a study, an open-label and proof-of-concept trial evaluating the clinical and biological effects of Ā ATX-MS-1467, enrolled more than 90 relapsing MS patients and was led by Merck in Germany. Study goals include changes in contrast-enhancing brain lesions from baseline, as well as changes in mean annualized relapse rates, and results are expected to be announced before the end of the year.