Multiple Sclerosis (MS) is an inflammatory and degenerative disease of the brain that produces significant disability. MS is the second cause of permanent disability in young adults and half of them are going to end their life with significant disability (restricted to a wheel-chair). Its prevalence rate varies between races and geographical latitude, ranging from more than 100 per 100,000 in Northern and Central Europe to 50 per 100,000 in Southern Europe. Today over 2,000,000 people around the world have MS, including 30-40,000 in Spain (more than 350,000 people in the United States).
Current disease modifying drugs for MS (Interferon-beta, Glatiramer acetate, Natalizumab, Chemotherapy) improve disease course but with limited efficacy and significant side-effects and inconvenient route of administration (parenteral). Overall patient’s quality of life slightly benefited from these therapies. For these reasons there is a big room for improvement by developing more efficacious drugs (targeting inflammation but also neurodegeneration), safer (avoiding life-threatening adverse events (fatal infections, cancer) and non-serious adverse events that impairs quality of life (e.g. flu-like symptoms), oral administration and with good profile for combination therapy.
OUR PROPOSAL: ORAL NT-KO-OO3 FOR THE TREATMENT OF MULTIPLE SCLEROSIS
Neurotec Pharma is developing a new oral treatment for MS focused on re-profiling of NT-KO-003 based on a novel mechanism of action.
NT-KO-003 is a generic compound (small molecule) used systemically (IV and oral) for more than 25 years for acute and chronic treatment of peripheral diseases. This molecule has been used for a long time in patients and thus well documented clinical experience in humans exists to establish its safety profile with oral doses. Consistent preclinical and clinical safety package is available.
Recently, the investigator’s team of Neurotec have found that low dose of NT-KO-003 inhibits microglia activation, preventing neuronal damage secondary to inflammation in a murine model of experimental autoimmune encephalomyelitis (EAE) accepted for MS.
Oral administration of low-doses of NT-KO-003 clearly modified the course and the severity of the disease with a significant clinical improvement of treated animals.
NT-KO-003 improves spinal cord damage in EAE treated animals. showing less demyelinization, a decreased glial and macrophage reactivity and neuroprotection.
Based on these results, Neurotec plans to conduct a Clinical Phase IIa in Relapsing Remitting-Multiple Sclerosis (RR-MS) patients that is going to begin in May 2011 (NeuroAdvan Project).