Here Today
5月前
Annovis Bio Receives FDA Approval to Transition to New Crystal Form of Buntanetap
MALVERN, Pa.
July 16, 2024 (GLOBE NEWSWIRE) -- via IBN – Annovis Bio Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative disorders such as Alzheimer’s Disease (AD) and Parkinson’s Disease (PD), announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to transition to a new solid form of buntanetap in future clinical trials.
In June 2024, Annovis announced the filing of a composition of matter patent for the new crystal form of buntanetap and a provisional patent for the manufacturing process of this new form. The Company conducted comprehensive bridge studies in various solvents and in animals, comparing the old semi-crystalline form with the new crystalline form of buntanetap. Additionally, Annovis developed an innovative large-scale manufacturing process for the new form. This comprehensive data was submitted to the FDA for review.
The FDA has now approved the continuation of buntanetap's development using the new crystal form. This positive response allows Annovis to conduct a comparative study between the old and new forms of buntanetap in a small, single-dose, bioavailability study in humans as part of the transition process.
XenaLives
5月前
So checking out Seeking Alpha today....
[Three things to note here:
The "dose-dependent and statistically significant improvements in cognition in the overall enrolled PD population" (n=523) is an inverse one, i.e., 10mg improved more than 20mg.
This inverse "dose-dependent" improvement in cognition occurs in the overall enrolled patients (n=523), but is reversed in the "Mild Dementia MMSE 20-26" subgroup, where the 10mg group has no statistically significant improvement.
MMSE improvement data is the only data reported from the entire enrolled patients (n=523) in the PR./quote]
https://seekingalpha.com/article/4702593-annovis-bio-a-close-look-at-their-parkinsons-trial-data
I've been following Anavex for years, and I believe their approach is better,
Anavex Life Sciences Reports New Mechanism of Action Data Related to ANAVEX Compounds Targeting Sigma-1 Receptor
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Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, announced today the presentation of new mechanism of action data related to ANAVEX compounds targeting the sigma-1 receptor at the AD/PDTM 2017 Meeting.
Hall H et al presented preclinical data indicating that during pathological conditions, ANAVEX 3-71 demonstrated the formation of new synapses between neurons (synaptogenesis) without causing an abnormal increase in the number of astrocytes. In neurodegenerative diseases like Alzheimer’s and Parkinson’s disease, synaptogenesis is believed to be impaired.
Goguadze N et al presented preclinical data indicating that in addition to reducing oxidative stress, ANAVEX 2-73, ANAVEX 3-71 and ANAVEX 1-41 also demonstrated protective effects of the mitochondrial enzyme complexes I and IV during pathological conditions. The mitochondrial enzyme complex IV is directly involved in the synthesis of ATP, which provides energy within cells for metabolism. It is believed that energy production impairment and mitochondrial dysfunction play a role in the pathogenesis of neurodegenerative disorders and neurodevelopmental diseases.
“These new results provide converging evidence on mechanism of action as well as possible disease-modifying properties potentially by restoring homeostasis by means of the sigma-1 receptor agonists in our pipeline. This data also provides a foundation for our ongoing translational research efforts,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.
Both data sets described that Aß1-42 (amyloid beta) significantly impairs biological function in the respective animal models and the observed regain of function confirmed the protective potential of ANAVEX sigma-1 receptor agonists against amyloid beta -induced toxicity. The former presentation further reported that although that the transgenic McGill rats had a very late stage of Alzheimer’s disease-like pathology (13 months of age), treatment with ANAVEX 3-71 fully reversed cognitive deficits, reduced amyloid pathology and also significantly reduced inflammation. Furthermore, the sustained recovery in cognition and pathophysiology observed following a month-long washout phase in advanced pathology (19 months of age) strongly suggests true disease-modifying properties of ANAVEX 3-71.
AI agrees with me -
query:
does clearing amyloid plaque stop alzheimer's disease
Search Labs | AI Overview
Learn more
…
No, clearing amyloid plaque alone is not likely to stop Alzheimer's disease. While amyloid plaque buildup is a hallmark of Alzheimer's disease, researchers believe that other factors also contribute to its progression, such as tau protein tangles, immune function, and vascular health. In fact, some research suggests that 25% of people with a clinical diagnosis of Alzheimer's disease have little to no amyloid in their brains.
XenaLives
5月前
The chart shows 5 minutes, apparently some trades were voided...
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