"This trial has been very successful and clearly shows there are no safety and tolerability issues around ATX-MS-1467, said David Wraith, CSO of Apitope and Professor of Experimental Pathology at the University of Bristol. “Beyond this, one of our patients has shown a remarkable improvement in her eyesight. Since the optic nerve is acutely sensitive to inflammation and optic neuritis is often one of the first symptoms of MS, this early indication of efficacy is very encouraging. It suggests that treatment with ATX-MS-1467 can suppress the inflammation associated with MS,” he added. “Now we are excellently positioned to begin proof of concept trials.
ATX-MS-1467 has been specifically designed and developed to treat MS patients; these results prove the Apitope platform can produce effective clinical compounds,” noted Dr Keith Martin, CEO of Apitope. “Moreover, in business terms ATX-MS-1467 and the related MS diagnostic, which was recently patented, give us several interesting partnership opportunities.”
The ATX-MS-1467 Phase I/IIa open label trial was designed as a dose-escalation study to assess the safety and tolerability with all six patients receiving five escalating doses given 7 to 14 days apart of 25, 50, 100, 400 and 800 followed by a repeat of the 800 µg dose.