In October the NeuroMax, Ltd private biotech company, financed by Maxwell Biotech Venture Fund, founded with the participation of RVC, obtained positive results of the preclinical trials of the efficiency and safety of the developed NM-IA-001 drug, which should become the first drug in Russia, intended for the pathogenetic treatment of diabetic neuropathy. These results enable the company to proceed with the stage of the clinical trials of this drug.
According to Nikolay Golub, CEO of the NeuroMax, Ltd: “The results of the preclinical trials give every reason to believe that the high efficiency and safety of this drug will also be confirmed by the clinical studies, which are scheduled be to started in the beginning of 2012”.
Yan Ryazantsev, director of the investment and expertise department at RVC, noted: “The results of the studies of preclinical efficiency and toxicity justify our hopes and give confidence to the members of the team, developing the drug. Completion of the preclinical trials within a year is a rather good result for a new team. Now the company has to accomplish more complicated tasks. We hope that, using the expertise of the fund’s specialists, the company will manage to overcome all the difficulties within the framework of the agreed schedule and will achieve the set goals”.
Nowadays, there are no pathogenetic treatment drugs in the market of drugs, intended to treat diabetes complications. NM-IA-001, developed by NeuroMax, is a low-molecular inhibitor of aldose reductase ferment. This drug considerably slows down diabetic neuropathy. The main indication of this drug is diabetic distal polyneuropathy and it can be additionally used for treating other diabetic complications, including diabetic nephropathy and retinopathy.
More information about the results of the preclinical trials of the drug
For this moment NeuroMax has completed a series of pre-clinical studies, including the study of acute and subacute toxicity, allergenicity, pharmacokinetics, immunotoxicity, reproductive toxicity, mutagenicity, carcinogenicity and specific pharmacological activity.
On the basis of the results, obtained in animals, it is possible to conclude that in case of the intragastric intake of NM-IA-001 in a therapeutic and 10-fold intermediate dose, this drug does not have a toxic effect. Its administration does not lead to the development of pathologic changes in the general health condition and behavior of animals, does not have a toxic effect on the cardiovascular system, morphologic composition, biochemical and other properties of the peripheral blood, bone marrow, as well as on the functional state of the liver and kidneys, protein, carbohydrate, fat and electrolytic types of metabolism. This drug does not cause pathomorphological changes, which confirms good tolerability and relative harmlessness of the substance. The substance does not have a locally irritant effect in case of its multiple intragastric intake. The substance intake in a maximum 25-fold dose leads to a number of proved changes in the 90th day of intake. These changes include a slight reduction of the physical activity, changes in a number of hematological and biochemical parameters, slight increase of the mass coefficients and dystrophic changes in the liver, thymus and kidneys. However, these changes are not clinically significant.
Bionevia Pharmaceuticals, Inc., an American biotech company. is a NeuroMax’ partner in product development.