Annovis Bio, Inc. - ANVS STOCK NEWS

Annovis Bio (NYSE: ANVS) has secured a U.S. patent for treating acute traumatic brain injuries (TBI) with its lead drug candidate, buntanetap. The patent (No. 12,042,482) covers methods for treating TBI and preventing nerve cell death. This achievement strengthens Annovis Bio's portfolio, which includes patents for using buntanetap in acute and chronic neurodegenerative diseases and mental illnesses.

CEO Maria Maccecchini highlighted the significance of this milestone, emphasizing buntanetap's potential to address nerve cell death in various brain conditions. Preclinical studies in TBI and stroke animal models have shown buntanetap's efficacy in preventing cell death and loss of function, demonstrating its potential benefits for brain trauma victims.

Annovis Bio (NYSE: ANVS) has received FDA approval to transition to a new crystal form of buntanetap in future clinical trials. This follows the company's June 2024 announcement of filing a composition of matter patent for the new crystal form and a provisional patent for its manufacturing process. Annovis conducted comprehensive bridge studies comparing the old semi-crystalline form with the new crystalline form in various solvents and animals. The company also developed a large-scale manufacturing process for the new form. The FDA's approval allows Annovis to conduct a comparative bioavailability study in humans as part of the transition process.

Annovis Bio (NYSE: ANVS) has announced the addition of four new executives to its leadership team, aiming to enhance their efforts in developing treatments for neurodegenerative disorders like Alzheimer's and Parkinson's diseases.

Mark White, a global pharmaceutical marketing expert who served as VP of Worldwide Marketing at Pfizer, is now the Chief Business Officer. Dr. Alexander Morin, with a background in neuroscience and strategic communications, has been appointed Director of Strategic Communications. Hilda Maibach, an expert in clinical and observational studies with over 30 years of experience, is the new Senior Vice President of Statistics. Lastly, Blake Jensen, with two decades of experience in quality management and regulatory inspections, has been appointed Head of Quality.

CEO Dr. Maria Maccecchini emphasized that these leadership additions are important as Annovis Bio advances its drug candidate buntanetap towards regulatory approval and market introduction.

Annovis Bio released promising new data from its Phase III study on buntanetap for Parkinson’s Disease (PD). The drug showed dose-dependent, statistically significant improvements in cognition and motor functions. Key findings include significant enhancements in the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scores and cognitive function, particularly in patients with over three years of PD diagnosis and those with Postural Instability and Gait Difficulties (PIGD). Buntanetap also halted cognitive decline in all patients and improved cognition in those with mild dementia. The safety profile was consistent across all groups. The company is committed to advancing buntanetap to further explore its benefits.

Annovis Bio announced the filing of a provisional patent for a new manufacturing process of a crystalline form of buntanetap, a drug for neurodegenerative disorders like Alzheimer's and Parkinson's diseases. This new process provides significant benefits, including high product purity, excellent yields, and the avoidance of genotoxic reagents. The company aims to submit the Chemistry, Manufacturing, and Controls (CMC) protocol to the FDA in July, with plans to continue the drug's development and file a New Drug Application (NDA).

Annovis Bio announced filing a new composition of matter patent with the U.S. Patent and Trademark Office for novel crystalline forms of buntanetap, enhancing its solubility and stability for treating neurodegenerative disorders like Alzheimer’s and Parkinson’s. This builds upon a provisional patent from June 2023. The most stable crystal form has been selected for animal bridge studies and manufacturing process development. These studies were submitted to the FDA and will be discussed in July. This patent provides 20-year protection, aiding the company's drug development and market introduction plans.

Annovis Bio (NYSE: ANVS) has scheduled a webcast for July 2, 2024, at 4:30 PM ET to discuss developments concerning its lead drug candidate, Buntanetap, which targets neurodegenerative disorders like Alzheimer's and Parkinson's diseases. The webcast will cover recent advancements, strategic plans for upcoming clinical trials, and an overview of the company's progress and future direction. Investors and interested parties are encouraged to register in advance for the event.

Annovis Bio (NYSE: ANVS) will present new Alzheimer's data at the Alzheimer's Association International Conference (AAIC) 2024.

The event is scheduled from July 28 to August 1, 2024, in Philadelphia and online. Dr. Cheng Fang, Senior VP of Research & Development at Annovis Bio, along with Kathleen A. Welsh-Bohmer, Ph.D., and Maria L. Maccecchini, Ph.D., will present on July 31.

The 45-minute session will feature significant findings from Phase 2/3 studies of Buntanetap in patients with mild Alzheimer's Disease (AD). The presentation will address the drug's efficacy and safety in both APOE4 carriers and non-carriers, positioning Buntanetap as a potential breakthrough treatment for AD.

The abstract will be published in Alzheimer's & Dementia: The Journal of the Alzheimer’s Association post-conference.

Annovis Bio announced positive results from its Phase II/III Alzheimer's study of Buntanetap, showing effective and safe outcomes in high-risk Alzheimer's patients, including APOE4 carriers.

The study revealed a significant dose-response in early AD patients with improvements in ADAS-Cog11 scores, showing a -3.3 points improvement over baseline and -2.3 points over placebo.

APOE4 carriers treated with 15mg Buntanetap showed a -3.15 improvement in ADAS-Cog11 scores. The drug was also deemed safe, with no reported instances of ARIA.

The trial included 318 participants, with equal numbers of APOE4 carriers and non-carriers.

Annovis is planning an 18-month Phase III trial focusing on biomarker-positive early AD patients, further validating the drug's efficacy and safety.

An investor call discussing these findings is scheduled for June 11, 2024, at 4:30 PM ET.