Biotechnological companies Advancell and Neurotec Pharma, both based in Barcelona, Spain, have initiated a clinical phase IIa study with NT-KO-003, an innovative oral therapy for multiple sclerosis (MS). NT-KO-003 was co-developed by the two companies and its mechanism of action is completely different from the drugs currently used to treat MS.
The clinical trial, called NeuroAdvan, will be conducted in 105 patients from 11 hospitals in Spain and three in Germany, and will be led by Dr. Pablo Villoslada, director of Neuroimmunology at IDIBAPS, Hospital Clinic de Barcelona, Spain. Results from the study are expected in late 2012.
MS affects about 30,000 people in Spain, according to the Spanish Association of Multiple Sclerosis, and about 2.5 million worldwide, according to the World Health Organization (WHO). MS mainly affects young adults (mostly women), aged 20 to 50.
In animal models during the preclinical phase, NT-KO-003 has demonstrated an anti-inflammatory and neuroprotective effect, rather than an immunosuppressive effect. NT-KO-003 can be combined with other drugs when necessary without increasing toxicity and can be administered to nearly all patients affected by the disease. It is also one of the first oral treatments that can potentially slow the progression of MS and reduce the neurological damage caused by the disease.
Because of its neuroprotective mechanism of action, Advancell and Neurotec are exploring the possibility of using NT-KO-003 in the treatment of other neuromuscular diseases, such as amyotrophic lateral sclerosis, which mainly affects men aged between 40 and 70 and causes the death of 50% of patients it in the first three years after the onset of symptoms.
Advancell and Neurotec Pharma will receive funding support from the Catalan Local Government, through the Nuclis of Technological Innovation Program of ACC1O, and from the Ministry of Science and Innovation, through the subprogram INNPACTO, which is part of the National Plan for Scientific Research, Technological Development and Innovation 2008-2011 ( IPT-010000-2010-035). Both programs are financed by the European Regional Development Fund (FEDER).