WP1303's major indication is Multiple Sclerosis (MS), a chronic, unpredictable and incurable disease of the central nervous system, as a result of the immune system attacking healthy tissue causing inflammation and damaging the myelin sheath (the protective insulation surrounding nerve fibres), oligodendrocytes (cells that make central nervous system myelin) and subsequently damaging the underlying nerve fibre. MS can cause many debilitating symptoms that over time may come and go, or persist and worsen, including blurred vision, loss of balance, poor coordination, slurred speech, tremors, numbness, extreme fatigue, problems with memory and concentration, paralysis, blindness and more. MS can either be progressive or be characterized by periods of relapse and remission; the unpredictable nature of the disease makes life very hard for patients. Relapsing-remitting MS is the most common form of MS with 85% of new diagnoses. Most people are diagnosed with MS between the ages of 20 and 50, and the World Health Organization estimates that more than 2.5 million people suffer from MS worldwide (Haussleite I. et al., 2009).
WP1303 is the first potential therapeutic for MS that combines high efficacy with an excellent, and thereby differentiating, safety profile. Phase IIa study results demonstrated a significant reduction in total new and persisting lesions as well as the volume of lesions, and has showed a highly favorable and differentiating safety profile with zero treatment-related serious or severe adverse events across the 68 patients treated in clinical studies to date. Importantly, WP1303 halted progression of the disease and demonstrated a strong trend towards overall reduction in disability during the Phase IIa study, underpinned by a significant improvement in cognition after six months of treatment. Worg believes this constitutes one of the first reports of an improvement in cognition following immunotherapy in patients with MS based on their assessment of the market.
Most current treatments for MS globally suppress the immune system (thereby increasing the risk of life-threatening infections, cancers and other immune complications). The reduced relapse frequency and slowing of the progression of MS, comes at the cost of increased side effects resulting in a poor pay-off between efficacy and safety. WP1303 addresses the significant medical need for a high relapse reduction in combination with high tolerability, with the additional potential to improve cognitive disability in MS patients.
In addition to MS, the same peptide mixture of WP1303 could be indicated for MS-related Intermediate & Posterior Uveitis, and the relevant clinical investigation is at the stage of initiating Phase 2.