My Top Pick for 2017 is a clinical-stage biopharmaceutical company involved in the treatment of neurodegenerative diseases, explains small cap expert Tom Bishop, editor BI Research.
The lead drug from Anavex Life Sciences (AVXL) — called Anavex 2-73 — has just reported very promising phase 2a results in Alzheimer’s patients at the annual CTAD conference.
Test results from 25 patients are hovering near baseline after one year, or even improving for some, while the normal course is steady deterioration in cognition and activities of daily living.
No drug currently on the market can do more than slow the deterioration for at best 6 months.
This prompted the editor of the Journal of Alzheimer’s Disease to comment he has never seen any drug perform this well on Alzheimer’s patients. Patients and caregivers have requested to continue to be able to take the drug.
One woman who could no longer play the piano is now able to play again. Another who could no longer paint is painting again and hosting an art show. Another is back on the golf course.
A fourth was able to give a very lucid, even humorous interview on Australian TV where before he would have absolutely refused. Friends and relatives of these trial participants cannot believe the improvements.
Planning for a larger pivotal placebo controlled Phase 2/3 trial is well under way. If results are confirmed this will be a multi-billion dollar drug.
Meanwhile A2-73 has successfully completed lab testing for Parkinson’s funded by the Michael J. Fox Foundation and is now prepping for a Phase 2 trial.
In addition, A2-73 has attracted the interest of Biogen (BIIB), which is conducting lab testing for possible use against MS.
The company is also preparing a Phase 2 placebo controlled trial testing A2-73 on Rett Syndrome. In short, 2017 should be an exciting year.
More "DD" with reference to a Biogen b/o or partnership. Know your enemy/competitor.
Biogen's pipeline contains three Alzheimer's drug candidates none of which were in house drugs but rather drugs initially invented by two other companies, Neurimmune(Swiss) and Eisai Co Ltd(Japanese) Biogen is partnering with both companies and has bought into Aducanumab from Neurimmune. to the tune of $386M plus royalties. The drugs:
Aducanumab was developed by Neurimmune under their Reverse Translational Medicine program and is a recombinent human monoclonal antibody that binds to and may reduce amyloid plaques from the brain. It has just begun a huge Phase 3 trial that includes 2700 participants in hundreds of sites in 20 countries. Results are expected in 2022! See more at:
E2609(BACE1 inhibitor) Phase 3 and BAN2401 Phase 2 were originally developed buy Eisai. E2609 inhibits BACE1 and blocks amyloid production, while BAN2401 is an antibody that binds to amyloid which could reduce its presence in the brain.
In Biogen's website this statement follows the description of each drug..."and potentially slow the progress of the disease."
Given the enormous of cost and duration of Aducanumab's Phase 3 trial and the recent failure of Lily's amyloid plaque drug it would not take much verified progress of 2-73 to push Biogen's BOD to cancel the expenditures for all three amyloid plaque drugs.
IMHO that would start a scramble to partner with Anavex between Biogen, Lily and possibly Eisai which is a 2 Trillion yen(20 B$) company whose pipeline dwarfs Biogen's (Humira, Aricept/donepezil to name a couple)
By the way, it is Biogen's MS drug candidate BIIB061 which the company is evaluating 2-73 against. Although, Biogen has 6 MS drugs on the market, They all have serious side effects or patient limitations. They Need safe success with 061 or a combo!