Multiple Sclerosis

Multiple Sclerosis is caused when T cells, components of the immune system that normally lead the attack against foreign invaders of the body, instead target nerves in the spinal cord and brain creating lesions in myelin, the protective sheath around nerve axons.  In MS, activation of T cells triggers the release of inflammatory cytokines that lead to the destruction of the myelin protein layer.  In the immune system, specific cells called macrophages are designated as antigen presenting cells.  It is the job of these cells to scavenge and engulf foreign proteins and degrade them into peptide fragments.  In MS patients, these peptides are often a fragment of myelin from the patients own myelin sheath.

Artielle’s RTL molecules are designed to turn off neuropathic immune cells by suppressing and/or reprogramming the specific subpopulation of T cells that promote the inflammatory response.  Due to this specificity, RTLs are less likely to induce the serious side effects seen with current non-specific immunosuppressive therapies. Artielle has tested its RTLs on three different animal models of MS.  In each case, our treatment has shown to be effective in both preventing and significantly reducing the symptoms associated with MS.  In our animal models, RTL1000 has been shown to result in the repair of both the myelin sheath and axons. Our drugs are produced relatively inexpensively from microbial cells, a major advantage over those competitors whose therapeutics must be produced in expensive mammalian cell culture systems.  Because of the elegant design of our RTLs, these compounds can be tailored to address different autoimmune diseases.

Artielle has completed animal toxicology and pharmacokinetics studies, the manufacture of RTL1000 under current Good Manufacturing Practices, filed our Investigative New Drug (IND) application with the FDA and received permission to commence Phase I clinical trials.

The Phase 1 trial will be a multi-center, double-blind, placebo controlled, dose escalation study. The primary objective of this trial is to evaluate the safety of a single dose of RTL1000 and is expected to last about one year. Based on our safety and efficacy data we are very optimistic that these trials will be successful. A Phase 2 multiple dose trial will follow and will examine both the safety and efficacy of RTL1000 in a greater patient population.