Artielle ImmunoTherapeutics (Artielle) has provided the results of a phase 1 safety study of RTL1000, a recombinant T-Cell receptor ligand specific for an immunodominant MOG peptide, in multiple sclerosis.
Reportedly, the data showed that the phase 1 Study met its primary objective, which was to evaluate the safety profile and determine the maximum tolerated dose (MTD) of a single IV dose of RTL1000.
Moreover, secondary objectives of the study were also met, these were to determine the pharmacokinetic profile of RTL1000 and assess immunologic parameters in a subset of Multiple Sclerosis (MS) patients.
The study was a first-in-human, double-blind, placebo controlled trial that enrolled 34 subjects with relapsing remitting and secondary progressive MS at six centers in the US. All subjects were followed for clinical and MRI changes, pharmacokinetics and cytokine levels in plasma and blood mononuclear cells.
Al Ferro, president and CEO of Artielle, said: “The successful completion of this phase 1 study represents a major milestone in the potential treatment of this devastating disease and in the development of our proprietary platform technology. We plan to move aggressively to bring these novel, first-in-class products to the market place.”