Quote: "It doesn't take a rocket scientist to know that AVXL's stock price will continue to go lower without a positive fundamental news event."
I respectfully disagree.
As I stated before, there is a very good possibility that AVXL will rally based solely on news that ANVS is successful with their AD and/or PD trial. If you recall, Anavex rallied to $30/share based solely on the success of SAVA's AD results...so we could easily duplicate that scenario if ANVS is successful. (See below for ANVS trial results date)
Clinical Updates
Announced Last Patient Last Visit in the Phase III Study of Buntanetap in Parkinson's Disease (PD)
On December 5, 2023, the Company announced the last patient last visit for its PD Phase III study of buntanetap and reported a substantial level of participation with patients enrolled at record pace. Out of 616 total patients screened, 523 were enrolled and 471 completed the trial across 67 sites (43 in the United States and 24 in the European Union). The Company confirmed screen failure (15%) and drop out (9.9%) rates that were below projections.
Reported Full Enrollment for its Phase II/III Alzheimer's Disease (AD) Trial Exceeding Original Projections
On November 27, 2023, the Company announced full enrollment for its AD Phase II/III study of buntanetap. With over 700 patients screened, a total of 353 patients were enrolled across 54 sites in the United States, well above originally planned 320 patients, exceeding the initial projections. The Phase II/III study was a randomized, double-blind, placebo-controlled trial investigating the efficacy, safety, and tolerability of buntanetap in patients with mild to moderate AD. Patients received either one of three doses of buntanetap (7.5mg, 15mg, or 30mg) or placebo on top of their standard of care for 12 weeks. The Company recently declared a database lock and updated the timeline for top line efficacy data, now expected in April.
Issued Novel Biomarker Measurements in Plasma of Parkinson's Patients
On November 2, 2023, the Company reported new data of important biomarkers in plasma of PD patients, in addition to previously measured biomarkers in CSF. The data showed a statistically significant drop in the levels of TAR DNA-binding protein 43 (TDP43), one of the neurotoxic proteins which is correlated with impaired axonal transport, inflammation, and nerve cell death. To our knowledge, it is the first time that a drug has reduced TDP43 levels in humans. The data also supports the unique mechanism of action of buntanetap in that it inhibits more than one neurotoxic aggregating protein. Evaluating biomarkers in plasma rather than in CSF is a considerable improvement for patients as well as for the sites conducting the study. Plasma biomarkers allow for monitoring the progression of the disease, while making it easy on both patients and doctors.
Message from Dr. Maria L. Maccecchini
"During the fourth quarter of last year, we witnessed a remarkable momentum in our mission to bring novel therapeutics for neurodegenerative diseases, as both of our clinical trials for Alzheimer's and Parkinson's progressed significantly. In December, we completed the Phase III PD study, and we are currently in the process of meticulously cleaning the data. The AD Phase II/III study was completed in February, and we announced that we cleaned the data to our satisfaction and will release top-line efficacy results in April.
Annovis Announces Publication That Supports Understanding of Buntanetap's Mechanism of Action in Humans
MALVERN, Pa., April 01, 2024 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases, today announced the publication of new data from an earlier study supporting buntanetap as a translational inhibitor of amyloid precursor protein (APP) in patients with early Alzheimer's Disease (AD).
Buntanetap is an oral molecule that selectively binds to an iron-responsive element in the mRNA of APP and other neurotoxic proteins and inhibits their translation. Through this mechanism, buntanetap was shown to decrease the production of amyloid beta (AB), a key hallmark in AD. This study, which was finished in 2021, aimed to assess pharmacodynamic effects of buntanetap on the translation of APP mRNA by employing Stable Isotope Labeling Kinetics (SILK). SILK measures the translation, steady state, and degradation of a protein in the cerebrospinal fluid (CSF) and is able to detect subtle protein changes, which cannot be measured in normal CSF sampling. Here, SILK was used to measure the kinetics of APP in early AD patients and to quantify AB40 in CSF.
In this randomized, double-blind, placebo-controlled study, participants received oral buntanetap (1x60, 2x60 and 3x60 mg per day or placebo) up to a 25-day period. At the end of the study, patients were catharized in the lumbar spine for 36 hours to accommodate the total time it takes for APP to be synthesized, processed into AB, and degraded. A total of 15 patients completed the study. Notably, the analysis of adverse events demonstrated no dose-dependent effect of buntanetap compared to placebo, affirming the drug's safety and tolerability. Furthermore, multiparameter modeling of APP kinetics provided additional evidence for dose-dependent lowering of APP production by buntanetap. A model that included the pre-drug lumbar CSF concentration as a covariate showed statistical significance between the placebo and 120, 180 mg per day buntanetap groups, suggesting a drug effect on lowering APP production. In general, buntanetap lowered the rate of translation, the maximum concentration (Cmax), lengthened the Tmax, and decreased the area under the curve (AUC). It is important to note that the results were not statistically significant (other than the difference between placebo and 120 and 180 mg mentioned above) due to a very small number of patients; however, the demonstrated trend fully mirrors the mechanism of action of buntanetap as a translational inhibitor of APP.
About Buntanetap
Buntanetap (formerly known as Posiphen or ANVS401) attacks neurodegeneration by inhibiting the formation of multiple neurotoxic proteins - amyloid beta, tau, alpha synuclein, and TDP43 - thereby improving synaptic transmission, axonal transport and neuroinflammation. Dysregulation of these pathways has been shown to be the cause of nerve cell degeneration and ultimately death. By attacking these pathways, buntanetap has the ability to reverse neurodegeneration in Alzheimer's Disease.
About Annovis Bio, Inc.
Headquartered in Malvern, Pennsylvania, Annovis Bio, Inc. is a clinical-stage, drug platform company addressing neurodegeneration, such as Alzheimer's Disease (AD), Parkinson's Disease (PD), and other chronic neurodegenerative diseases. It is believed to be the only company developing a drug for both AD and PD designed to inhibit more than one neurotoxic protein to restore axonal and synaptic activity. By improving brain function, the company's goal is to treat memory loss and dementia associated with AD as well as body and brain dysfunction associated with PD. For more information on Annovis Bio, please visit the Company's website www.annovisbio.com and follow us on LinkedIn and Twitter.
