Anavex Life Sciences Corp (NASDAQ:AVXL) began phase 1 clinical study of innovative formulation ANAVEX3-71 by enrolling the first patient. The small molecule, which is indicated for the treatment of neurodegenerative diseases through oral administration, targets M1 and Sigma-1 muscarinic receptors to provide an effective cure. Anavex expects to receive first-line data of the drug in H1 in 2021.
Measures effectiveness of Anavex3-71
CEO and President of Anavex, Christopher U Missling, said the company is excited with the preclinical data achieved from Anavex3-71. The company is enrolling healthy volunteers that comprise 36 females and males for this program to learn more about the benefits of this innovative drug in treating neurodegenerative diseases.
The company will evaluate pharmacokinetics, tolerability, and safety of Anavex3-71 in phase 1 by gradually increasing the dosage against a placebo. After phase 1, a longer study will be conducted in patients suffering from FTD. It will include disease biomarkers and exploratory efficacy measures in this longer study.
Anavex targets the new drug to cure FTD
Previously Anavex3-71 received an orphan drug classification from the US FDA. The company developed this drug to treat FTD (Frontotemporal Dementia) initially. According to a study, Anavex3-71 exhibited promising disease-modifying activities against amyloid, cognitive defects, and tau pathologies. It is also beneficial for the treatment of neuroinflammation and mitochondrial dysfunction.
Administers dose to the first patient in ANAVEX2-73-RS-003 study
Anavex administered the dose to the first patient in the Phase 2/3 clinical study of ANAVEX2-73-RS-003, which is developed to cure Rett Syndrome. The company will involve a minimum of 69 patients in this clinical trial over 12 weeks to investigate the drug’s efficacy and safety. It will offer ANAVEX2-73 to all the participants in this study under the open-label extension.
Anavex previously received fast track designation for its new investigational drug – ANAVEX2-73 to cure Rett Syndrome. It also received orphan drug designation and Rare Pediatric Disease Designation from the US FDA for this drug.
Anavex engages in developing innovative therapies to treat neurodevelopmental and neurodegenerative diseases that comprise central nervous system diseases, Rett Syndrome, Parkinson’s disease, and Alzheimer’s disease. The company reported a net loss of $7.2 million in Q2 2020. The company spent $6.1 million on R&D.
