Tuesday, May 09, 2023 3:38:42 PM
Anavex’s (AVXL $9.20, +9%) (… and wow, Aris is up 25% this morning, I’ll hit that next!) quarterly release and conference call was this morning. And after speaking with the Company and clarifying a few issues, there were some exciting revelations. First and foremost, the Company now believes, after 5 months of evaluating the data, that the data from the resent Phase 2b/3 Alzheimer’s trial, and especially the data from the improvement in surrogate biomarkers that are associated with the pathology of Alzheimer’s are strong enough that it intends to apply to the FDA for approval of A2-73 based on the “Accelerated Approval Pathway.” Now this doesn’t just mean the process moves along more quickly while it now does a full phase 3 trial. This means conditional approval for commercial sale of A2-73 based on the data already collected from the Phase 2b/3 trial, especially that based on improvement in the various Alzheimer’s disease pathology biomarkers, along with the cognitive and other improvements in functional data itself. And then a confirmatory study would be done while the drug is already approved. Recent Alzheimer’s drug approvals (Biogen and Lilly) have all utilized this pathway and evidence of improvement of various biomarkers for Alzheimer’s disease. So this is rather exciting as there is a reasonable chance now that the Company could get approval relatively soon without waiting to first conduct a full blown Phase 3 trial. No guarantees on this, but very encouraging re the potential time line to market acceleration. Here is something more on this pathway–
“The pathway specifically allows FDA to approve drugs based on a determination that the product has an effect on certain surrogate endpoints or intermediate clinical endpoints. Surrogate or intermediate endpoint can be based on a laboratory measurement (like blood glucose level for diabetes), radiographic image (like tumor size reduction), physical sign (like blood pressure for cardiovascular disease) or other measure. For instance, reduction of viral load in HIV patients, reduced tumor size in cancer patients or alleviation of symptoms can all be used to show a treatment’s benefit to patients. Congress has clarified, through statute, that the accelerated approval pathway does not alter the standards of evidence required for approval.
After a medicine is granted accelerated approval, companies are required to conduct, and provide updates on, confirmatory trials and the FDA is required to make this information publicly available.
Companies are required to conduct confirmatory studies of medicines granted accelerated approval and are subject to reporting requirements on the status of these studies. The FDA is required to track, and make publicly available, progress of confirmatory trials.”
Remember that the safety data is much better than those Alzheimer’s drugs recently approved that can cause brain swelling/bleeding (maybe even death) and the need for periodic/expensive MRI’s to monitor this. AND A2-73 is an oral formulation not infusion therapy. So all things being equal, what are you gonna take?
Now the other cool thing here is, as announced in a press release last week, the Company has filed for a patent covering A2-73’s use to lower high blood pressure. As you might expect, when patients came in for periodic trial evaluations, they got their blood pressure taken. And the Company noticed that those coming in with high blood pressure saw that drop back into the normal range! So while the Company is a ways off from pursuing this indication on its own, if it can claim this side benefit, in addition to the Alzheimer’s benefits above … like I said, which one are you gonna choose? Duh. (I also recall some potential benefits regarding improved sleep, I hope we get data on that also.) It’s like how they have discovered lately that some of the diabetes drugs (Eli Lilly’s in particular)) cause significant weight loss! So now these diabetes drugs are in short supply because other people are taking them just for weight loss. So A2-73, if approved, could then potentially be prescribed off label for blood pressure, or at least more likely advertised as a side benefit. The blood pressure data has not been disclosed but perhaps will be in the full release in a medical journal that will cover all the things we have been waiting for (30 vs. 50 mg, ADL and COG, sigma1 normal gene vs. the variant, all the other biomarker data … ).
Elsewhere, I believe they are at last getting very close to announcing the Phase 3 Parkinson’s disease trial initiation, in addition to the full A2-73 data release, plus in H2 the Rett Pediatric data. While this seems to move very slowly the Company is meticulous in its approach, avoiding the pitfalls so many companies fall into with their failed clinical trials and I would remind everybody once again that they have never failed one of their clinical trials. They have all been successful in showing efficacy, and that consistency itself tells you something. Small wonder Dr. Missling reiterated in closing that “… looking forward we’re very excited about the Company’s potential as well as to build the bio-marker driven precision medicine studies…”
There was more meat on the bone than today’s stock market reaction gives credit for (it was down in the pre-market but I see as I finish this that it is now up 8%, still … plenty of room ahead)- Buy.
Recent AVXL News
- Anavex Life Sciences to Present at the H.C. Wainwright 26th Annual Global Investment Conference 2024 • GlobeNewswire Inc. • 09/03/2024 11:30:00 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/06/2024 09:21:05 PM
- Anavex Life Sciences Reports Fiscal 2024 Third Quarter Financial Results and Provides Business Update • GlobeNewswire Inc. • 08/06/2024 11:30:00 AM
- Anavex Life Sciences to Announce Fiscal 2024 Third Quarter Financial Results on Tuesday, August 6, 2024 • GlobeNewswire Inc. • 08/01/2024 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/30/2024 09:20:53 PM
- Anavex Life Sciences Announces Translational Biomarker Data for ANAVEX®2-73 (blarcamesine) in Fragile X Syndrome (Major Cause of Autism) at the 19th NFXF International Fragile X Conference • GlobeNewswire Inc. • 07/30/2024 11:30:00 AM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 07/29/2024 09:21:49 PM
- Results from Anavex Life Sciences Landmark Phase IIb/III Trial of Blarcamesine Presented at Alzheimer's Association Conference • GlobeNewswire Inc. • 07/28/2024 09:00:00 PM
- Anavex Life Sciences to Present at the H.C. Wainwright 5th Annual Neuro Perspectives Virtual Conference • GlobeNewswire Inc. • 06/20/2024 11:30:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/17/2024 11:30:10 AM
- Anavex Life Sciences Announces Expansion of Leadership Team • GlobeNewswire Inc. • 05/22/2024 11:30:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/17/2024 10:01:00 AM
- Anavex Life Sciences to Present at the H.C. Wainwright 2nd BioConnect Investor Conference at NASDAQ • GlobeNewswire Inc. • 05/14/2024 11:30:00 AM
- Shareholders that lost money on Anavex Life Sciences Corporation(AVXL) Urged to Join Class Action - Contact The Gross Law Firm to Learn More • PR Newswire (US) • 05/10/2024 09:45:00 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/09/2024 08:35:55 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/09/2024 12:00:30 PM
- Anavex Life Sciences Reports Fiscal 2024 Second Quarter Financial Results and Provides Business Update • GlobeNewswire Inc. • 05/09/2024 11:30:00 AM
- The Gross Law Firm Announces the Filing of a Securities Class Action on Behalf of Anavex Life Sciences Corporation(AVXL) Shareholders • PR Newswire (US) • 05/07/2024 09:45:00 AM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/06/2024 10:03:33 AM
- Anavex Life Sciences Corporation Sued for Securities Law Violations - Contact The Gross Law Firm Before May 13, 2024 to Discuss Your Rights - AVXL • PR Newswire (US) • 05/03/2024 09:45:00 AM
- Anavex Life Sciences to Announce Fiscal 2024 Second Quarter Financial Results on Thursday, May 9th, 2024 • GlobeNewswire Inc. • 05/02/2024 11:30:00 AM
- May 13, 2024 Deadline: Contact The Gross Law Firm to Join Class Action Suit Against AVXL • PR Newswire (US) • 04/26/2024 09:45:00 AM
- Contact The Gross Law Firm by May 13, 2024 Deadline to Join Class Action Against Anavex Life Sciences Corporation(AVXL) • PR Newswire (US) • 04/19/2024 09:45:00 AM
- The Gross Law Firm Reminds Shareholders of a Lead Plaintiff Deadline of May 13, 2024 in Anavex Life Sciences Lawsuit - AVXL • PR Newswire (US) • 04/16/2024 09:45:00 AM
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