ChemRar Group announces the successful finish of the second phase of the clinical trial of the innovative generalized anxiety disorder drug
Avineuro Project from ChemRar Research Institute has finished the multicenter, randomized, double-blind, placebo-controlled pilot study of the efficacy, safety, and dosage of innovative drug AVN-101, (CD-008-0045), in patients with the generalized anxiety disorder (GAD). The study involved 129 patients.
The results prove that the patient condition improves after the peroral administration of the subject GAD drug, in case of no side effects. AVN-101 is a multitarget drug that can inhibit adrenergic, dopamine, serotonin, and histamine receptors [AVN-101: A Multi-Target Drug Candidate for the Treatment of CNS Disorders. Journal of Alzheimer’s Disease 2016, 53,583–620. Small Molecule 5-HT6R Ligands: A Comprehensive Insight into their Selectivity and Activity. Current Bioactive Compounds 2013, 9, 64-100.
According to the data derived, AVN-101 dosage is 40 mg/day, administered perorally twice a day during 8 weeks. In the selected dosage mode, the frequency of adverse events in patients taking the drug is almost consistent with the frequency of adverse events in patients taking the placebo. This proves the safety of the drug and allows the long-term administration thereof. Also, AVN-101 does not cause drowsiness.
The study results provide for considering moving the candidate drug to the third phase of the clinical trial.
AVN-101 is protected in all the major markets by means of patents of Russia, US, Europe, Eurasia, Japan, etc. Development results were repeatedly published in international rating journals.
Lyudmila Yamukova, the project lead, mentioned, “We are proud that our innovative drug, created from scratch by Russian scientists, could demonstrate such top-grade results. Considering the drug’s one-of-a-kind mode of action and its activity in various biotargets, it is safe for us to assume AVN-101 will be as effective in treating depression and mental disorders. Currently we are negotiating with Russian and foreign partners on bringing the drug into various markets within these nosology scope”.
Avineuro Project from ChemRar Research Institute is aimed at creating innovative products and services in the field of the central nervous system disorders, being part of the NeuroNet road map of the National Technology Initiative in the NeuroPharma line. The project is supported by the Ministry of Industry and Trade of the Russian Federation within the framework of program Pharma 2020.
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