Date: 2013-02-15
Type of information:
phase: 2a
Announcement: update
Company: Advancell (Spain) Neurotec Pharma (Spain)
Product: NT-KO-003
Action mechanism: NT-KO-003 is a repurposing drug. This generic compound is a small molecule used systemically (IV and oral) for more than 25 years for acute and chronic treatment of peripheral diseases. Unlike conventional drugs, Neurotec's molecule does not target the patient's immune system. Instead it is an anti-inflammatory and neuroprotector for the nervous system.
Disease: multiple sclerosis
Therapeutic area: Autoimmune diseases - Neurodegenerative diseases
Country: Spain, Germany
Trial details: 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. (NCT01428726)
Latest
news: * On February 15, 2013, Neurotec Pharma has announced that next August, the company will close its study on 100 patients that are currently treated with NT-KO-003 in 14 Spanish and 4 German hospitals. * On July 19, 2011, Advancell and Neurotec Pharma 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. Results from the study are expected in late 2012.
NT-KO-003 is destined for the treatment of relapsing-remitting multiple sclerosis, which is the most frequent clinical presentation of the disease, "although we also believe that it could be useful in progressive clinic presentations of the disease," explains Marco Pugliese, founder and CEO of Neurotec Pharma. He also incidates that "thanks to its union with certain potassium channels, the drug has a direct neuroprotector effect on the neurons when decreasing the toxicity associated to the increase of intracellular calcium. It also inhibits neural degeneration and regulates mitochondrial membrane potential, thus improving functionality."
Neurotec Pharma has also documented how NT-KO-003 regulates glial reactivity. The drug reduces the expression of proinflamatory factors like iNOS and the secretion of proinflammatory cytokines like TNF-alpha or inflammatory molecules such as nitric oxide.
Once the clinical phase is over, Neurotec plans to licence it to a multinational pharmaceutical company. The company has announced that is has already signed five confidentiality agreements with European, US and even Asian multinationals.
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 €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 €4 million, with an estimated potential market of around € 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.
