Multiple Sclerosis

Multiple sclerosis (T20K)

Multiple sclerosis (MS) is a debilitating, chronic autoimmune disease that affects the central nervous system. The disease emerges when certain immune cells cross the blood brain barrier and mistakenly start destroying myelin, the protective layer on CNS nerves. Unsheathed nerves compromise signal transmission, giving rise to symptoms such as vision loss, balance disorders and eventually paralysis.

Many of the available drugs are primarily intended for treatment during active periods of the disease. Current therapies may lead to tolerability and safety problems and sometimes require monitoring and tests which affects quality of life and health care costs negatively. Furthermore, most treatments need to be administered as infusions or injections, which can be inconvenient for the patients. Thus, there is a large need for new drugs that impact disease progression before tissue is damaged or destroyed, have fewer side effects and are easy to use.

Cyxone is developing T20K, a peptide that in preclinical models reduces inflammation by reversibly targeting IL-2, a well-known player in the break-down of myelin. In the mouse model of multiple sclerosis (EAE model), T20K significantly delays onset as well as severity of clinical symptom. This potentially disease preventing mechanism-of-action is unique and T20K could thus be effective in slowing down the disease progression, preventing disease flares and postponing the need of second-line treatments. Initial preclinical data suggest that T20K has long-lasting effects and is efficacious at low doses and thus administration does not have to be frequent.

Taken together, T20K could be efficacious for administration from time of diagnosis for mitigating or even preventing relapses that are hall marks of multiple sclerosis and is when tissue damage occurs.

Preclinical
Phase 1
Phase 2
Phase 3
Multiple Sclerosis

Project status and next steps

  • T20K has shown to be well tolerated in humans in a Phase 1a study when administrating T20K as an infusion. For further clinical development we are aiming for a more patient-friendly administration form
  • Preclinical studies to support a convenient administration of T20K are ongoing, and mandatory toxicological studies required to obtain regulatory approval for a clinical study in healthy individuals will follow
  • A Phase 1 study using the new administration form is expected to start in the second half of 2021
  • Cyxone intends to partner or out-license the project to a pharmaceutical company
  • T20K is covered by patents on all major geographical markets until 2032, with possibilities to further prolong the market exclusivity