Dr. Christopher U. Missling, Anavex’s president and chief executive officer, made the presentation at the Jefferies 2017 Global Healthcare Conference in New York City on June 9.
Anavex 2-73 addresses the misfolded proteins involved in several neurodegenerative diseases, including Alzheimer’s. It prompts the sigma-1 and M1 muscarinic receptors to help cells clear misfolded proteins.
In preclinical-trial studies before the Phase 2a trial, the company said Anavex 2-73 prevented, stopped, and even reversed Alzheimer’s.
In November 2016, the company reported that Anavex 2-73 prevented further decline in mental capacity in 32 people with mild to moderate Alzheimer’s. The objectives of the Phase 2a study (NCT02244541) were to establish the safety and the maximum dose of Anavex 2-73 that patients could tolerate. During the 41 weeks of treatment, oral doses ranging from 30 mg to 50 mg were well-tolerated, without causing adverse reactions.
Two of the trial’s secondary objectives were seeing how patients would respond to each dose level and determining whether the therapy could improve cognitive function. Another objective was to determine the drug’s bioavailability, or proportion that entered circulation. That proportion is one indication of whether a therapy will work.
Researchers used a number of tools to measure patients’ cognitive function: the Mini Mental State Examination; Cogstate battery; electroencephalographic activity; the event-related potentials, or ERP score; and the Alzheimer’s Disease Co-operative Study-Activities of Daily Living Inventory (ADSC-ADL) scale.
Researchers also evaluated ANAVEX 2-73 as an add-on therapy to Aricept, the current standard of care for the palliative treatment of Alzheimer’s. Palliative treatment refers to therapies that focus on maintaining quality of life.
The trial’s key finding was that none of the 32 patients who were treated experienced cognitive decline. Measures of brain activity, depressions and daily functioning were also stable during the treatment period.
Anavex is currently inviting patients to take part in an open-label Phase 2 extension study (NCT02756858). Researchers will continue to make Anavex 2-73 available to patients with mild to moderate Alzheimer’s who participated in the previous trial. This extension study will last 52 weeks.
This April, the company reported that its drug compounds reversed Alzheimer’s-related cognitive deficits in mice and improved processes connected with the disease. The presentations took place at the 13th International Conference on Alzheimer’s & Parkinson’s Diseases. They dealt with the treatments Anavex 2-73, Anavex 3-71, and Anavex 1-41.