Annovis Announces Publication That Supports Understanding of Buntanetap’s Mechanism of Action in Humans
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The recent findings on buntanetap offer promising insights into its potential as a therapeutic agent for Alzheimer's Disease. The utilization of Stable Isotope Labeling Kinetics (SILK) provides a robust method for measuring the pharmacodynamics of the drug, which is critical for understanding its efficacy and safety profile. SILK's ability to detect nuanced protein changes in the cerebrospinal fluid (CSF) lends credence to the study's findings, despite the small sample size. The lack of dose-dependent adverse events is a positive indicator of the drug's tolerability, which is a significant factor in the development of long-term treatments for chronic diseases such as AD.
However, the small cohort of 15 patients does raise concerns about the generalizability of the results. While the study shows a trend consistent with buntanetap's expected mechanism of action, the lack of statistical significance in some parameters suggests that larger studies are necessary to confirm efficacy. Investors should be cautious, as the drug is still in early stages of clinical development and further research is needed to validate these preliminary findings. The long-term impact on Annovis Bio's stock will hinge on subsequent trials that can corroborate these results on a larger scale and demonstrate clear clinical benefits.
Annovis Bio's announcement regarding buntanetap's impact on amyloid precursor protein (APP) translation is noteworthy from an investment perspective. The drug's ability to decrease the production of amyloid beta (Aβ), a significant biomarker of Alzheimer's, addresses a critical need in the market for effective AD treatments. The absence of a dose-dependent effect on adverse events and the dose-dependent lowering of APP production are particularly encouraging for the drug's future development prospects.
However, the financial implications for Annovis Bio hinge on the drug's progression through the regulatory pipeline. The study's preliminary nature and the small sample size mean that substantial investment in larger, phase 2 and 3 clinical trials is necessary. These trials are capital-intensive and carry a high risk of failure. Investors should monitor Annovis Bio's cash burn rate and fundraising activities, as the company will likely require additional capital to advance buntanetap through later-stage trials. The potential for partnership with larger pharmaceutical companies could also influence the company's financial trajectory and stock performance.
From a clinical standpoint, the use of buntanetap as a translational inhibitor presents a novel approach to targeting the pathophysiology of Alzheimer's Disease. The mechanism of selectively binding to the iron-responsive element in the mRNA of APP is a sophisticated strategy for reducing the production of harmful proteins like Aβ. The study's findings that buntanetap can lower the rate of translation and affect parameters such as Cmax and AUC are encouraging for its potential impact on disease progression.
However, the clinical relevance of these findings remains to be fully established. The translation of these pharmacodynamic effects into tangible clinical outcomes, such as improved cognition or delayed disease progression, is the next critical step. The safety profile demonstrated is an excellent starting point, but efficacy must be demonstrated in a larger, more diverse patient population to draw definitive conclusions. The neurology community will be watching closely for further developments, as the need for effective AD therapies remains high and any progress in this field is of great interest.
Further look at earlier Phase 1b study by ADCS unveils confirmatory data
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 (Aβ), 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 Aβ40 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 Aβ, 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.
Forward-Looking Statements
This press release contains "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The Company advises caution in reliance on forward-looking statements. Forward-looking statements include, without limitation, the Company's plans related to clinical trials. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially from those implied by forward-looking statements, including regarding patient enrollment, the effectiveness of buntanetap and the timing, effectiveness, and anticipated results of the Company's clinical trials evaluating the efficacy, safety, and tolerability of buntanetap. See also additional risk factors set forth in the Company's periodic filings with the SEC, including, but not limited to, those risks and uncertainties listed in the section entitled "Risk Factors," in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC. All forward-looking statements in this press release are based on information available to the Company as of the date of this filing. The Company expressly disclaims any obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
Investor Contacts:
Maria Maccecchini, Ph.D.
maccecchini@annovisbio.com
FAQ
What is the purpose of the Phase 1b study mentioned in the press release by Annovis Bio, Inc.?
How does buntanetap work in inhibiting amyloid precursor protein translation?
What method was used to measure APP translation and Aβ40 levels in the Phase 1b study?
How many patients participated in the Phase 1b study evaluating buntanetap?
What were the key findings regarding the safety and tolerability of buntanetap in the study?
