Under its terms, Apitope will regain full global rights over ATX-MS-1467, as well as all clinical data related to the compound. In 2009, the company granted exclusive global rights to Merck KGaA to develop and commercialize the treatment, now being evaluated in a nearly complete Phase 2a clinical trial (NCT01973491) in relapsing MS patients.
In MS, the body’s immune cells mistakenly attack the myelin sheaths that surround nerve cell fibers. ATX-MS-1467 is a potential disease-modifying agent with an 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 ‘switching off’ 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 a press release. “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, Germany-team members in advancing this programme to date.”
ATX-MS-1467 has successfully completed two Phase 1 clinical trials. The first included six patients with secondary progressive MS (SPMS), and the second 43 patients with relapsing MS. Both studies assessed the drug’s safety and biological disease parameters. Analysis of the magnetic resonance imaging (MRI) results (the studies’ primary endpoint) found 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 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.