Newron Pharmaceuticals S.p.A., a research and development company focused on novel CNS and pain therapies announced that it has received approval to start its first in-man trial in the US for NW-3509. The investigational new drug (IND) application for NW-3509 was filed on July 5, 2011. NW-3509 is the first selective, voltage gated sodium channel (VGSC) modulator, in development as an add-on therapy for schizophrenia.
Ravi Anand, M.D., Newron’s Chief Medical Officer, said, “This approval is extremely important as it allows Newron to move forward with the development of this exciting new approach to treating a major mental disorder. Newron has discussed with regulatory authorities innovative pathways to expediting the early clinical development of NW-3509 that will allow assessment of efficacy (PoC) and safety to be conducted at an early stage. NW-3509 selectively inhibits voltage gated sodium channels and normalizes aberrant neuronal firing and glutamatergic hyperactivity, that have been implicated in the patho-physiology of schizophrenia. These effects are predicted to enhance the efficacy of current serotonergic and dopaminergic blocking drugs that are the main stay of schizophrenia, but have been shown to be associated with sub-optimal efficacy in a large number of patients. Therefore, the addition of NW-3509 to the current treatments may extend the benefits in symptoms of psychosis, reduce their dose, and significantly reduce the side effects of these drugs.”
Date: August 12, 2011
Source: Newron Pharmaceuticals S.p.A.
Filed Under: Drug Discovery