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Start of in-patient clinical trials with NT-KO-003, the first neuroprotective drug for multiple sclerosis without immunosuppressive effects

By 15 de July de 2011November 18th, 2020No Comments
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 15.07.2011

Start of in-patient clinical trials with NT-KO-003, the first neuroprotective drug for multiple sclerosis without immunosuppressive effects

The biotechnological companies Advancell and Neurotec Pharma, both based in Barcelona Science Park (PCB), Spain, have announced the initiation of a clinical Phase IIa study with NT-KO-003, an innovative oral therapy for multiple sclerosis (MS). NT-KO-003 was codeveloped by both companies and its mechanism of action is completely different from the drugs currently used to treat this disease.


The clinical trial, called NeuroAdvan, will be conducted in 105 patients from 11 hospitals in Spain (4 of them in Catalonia) and 3 in Germany, and will be led by Dr Pablo Villoslada, director of Neuroimmunology at IDIBAPS, Hospital Clínic de Barcelona, Spain. The project is being conducted in collaboration with the MRI Analysis and Research Center in Neuroimaging and Multiple Sclerosis (CARM) at the Hospital Vall d’Hebron, Barcelona, led by Dr. Alex Rovira, and also with advice from Dr. Rafael Arroyo at the San Carlos Cinical Hospital, Madrid, Spainm and Dr. Xavier Montalban from Hospital Vall d’Hebron, 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 World Health Organization (WHO). MS mainly affects young adults (mostly women), aged between 20 and 50. The drugs currently used to treat MS are immunomodulators with significant side effects, limited effectiveness and require parenteral administration (intravenous or subcutaneous), thus making adherence to the therapies difficult.

In animal models during the preclinical phase, NT-KO-003 has demonstrated an anti-inflammatory and neuroprotective effect, rather than an immunosuppressive effect. Consequently, 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.

An investment of EUR 2.2 million will be made in this clinical trial, and Advancell and Neurotec Pharma will receive funding support from the Catalan Local Government, through the Nuclis of Technological Innovation Program of ACC1Ó, 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). The total cost of NT-KO-003 development is about EUR 4 million, with an estimated potential market of around EUR 5.3 billion.

This project will lead to clinical proof of concept of the first molecule arising from Neurotec’s research and Advancell reaffirms its business model of developing new drugs to Phase II. Once the trial has been successfully completed, both companies plan to license the drug to a pharmaceutical company, which will continue its development and bring it to market.