Core Viewpoint - Annovis Bio Inc. has initiated a pivotal Phase 3 study for its drug candidate, buntanetap, aimed at treating early Alzheimer's disease, marking a significant step towards market approval and addressing the needs of millions of patients [1][2]. Study Details - The Phase 3 trial is a randomized, placebo-controlled, double-blind study designed to assess the safety and efficacy of a daily dose of buntanetap over 18 months, with a 6-month symptomatic assessment followed by a 12-month evaluation of potential disease-modifying effects [3]. - The study protocol received FDA approval based on positive results from previous trials, which indicated significant cognitive improvement in a subgroup of early AD patients without safety concerns [3]. Financial Aspects - The company recently completed a public offering of 5,250,000 units, generating gross proceeds of $21 million, which will fund the initial 6-month portion of the study, with additional capital expected from warrant exercises for the 12-month phase [4]. Participant Enrollment - Annovis plans to enroll over 750 participants across approximately 100 sites in the United States, with the first two sites already recruiting patients [7]. Drug Mechanism - Buntanetap is an orally available molecule that targets neurodegeneration by inhibiting neurotoxic protein aggregation, improving axonal transport, synaptic transmission, and reducing neuroinflammation, potentially reversing neurodegeneration and enhancing patients' quality of life [8]. Company Overview - Annovis Bio Inc. is focused on developing therapies for neurodegenerative diseases, including Alzheimer's and Parkinson's disease, and is headquartered in Malvern, Pennsylvania [9].

Core Insights - Annovis Bio Inc. has initiated a pivotal Phase 3 study for its drug candidate, buntanetap, targeting early Alzheimer's disease (AD) [1][2] - The study aims to evaluate both symptomatic and potential disease-modifying effects of buntanetap, following promising results from previous trials [2][3] Study Design and Objectives - The Phase 3 trial is a randomized, placebo-controlled, double-blind study lasting 18 months, with a 6-month assessment of symptomatic effects and a subsequent 12-month evaluation of disease-modifying effects [3] - Primary outcomes will include cognitive assessment using the Alzheimer's Disease Assessment Scale-Cognitive 13 (ADAS-Cog13) and functional ability using the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-iADL) scale [6] Funding and Enrollment - The company completed a public offering of 5,250,000 units, raising gross proceeds of $21 million to fund the initial 6-month portion of the study [4] - Annovis plans to enroll over 750 participants across approximately 100 sites in the United States, with initial recruitment sites already operational [7] Drug Mechanism and Potential - Buntanetap is designed to inhibit neurotoxic protein aggregation, improving axonal transport and reducing neuroinflammation, which may reverse neurodegeneration and enhance patients' quality of life [8] Company Overview - Annovis Bio Inc. is focused on developing therapies for neurodegenerative diseases, including Alzheimer's and Parkinson's disease, and is headquartered in Malvern, Pennsylvania [9]

MALVERN, PA, Feb. 04, 2025 (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 diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced the closing of its previously announced underwritten public offering of 5,250,000 shares of common stock and warrants to purchase 5,250,000 shares of common stock at a combined public offering price of $4. ...

MALVERN, Pa., Feb. 03, 2025 (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 diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced the pricing of an underwritten public offering of 5,250,000 shares of common stock and warrants to purchase 5,250,000 shares of common stock at a combined public offering price of $4.00 per share. The war ...

MALVERN, Pa., Jan. 31, 2025 (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 diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), today announced that it intends to offer to sell common stock and warrants in an underwritten public offering. All of the common stock and warrants are to be sold by the Company. ThinkEquity is acting as sole book-runn ...

MALVERN, Pa, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Annovis Bio Inc. (NYSE:ANVS) ("Annovis" or the "Company"), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced it was granted the U.S. patent covering methods for the treatment and prevention of acute brain or nerve injuries using buntanetap. This newly issued patent is based on buntanetap's ability to reduce neurotoxicity a ...

MALVERN, Pa., Jan. 07, 2025 (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 diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), today announced that the FDA has accepted an updated protocol for the pivotal Phase 3 AD study, which is slated to begin in January 2025. In October 2024, the FDA granted clearance for Annovis to proceed with the pivota ...

LOS ANGELES, Dec. 05, 2024 (GLOBE NEWSWIRE) -- via IBN -- InvestorBrandNetwork, a multifaceted communications organization engaged in connecting public companies to the investment community, is pleased to announce Annovis Bio’s (NYSE: ANVS) recent feature on Today’s Marketplace (TMP) as part of its commitment to amplifying industry leaders’ voices through targeted distribution channels. The full interview can be viewed at https://ibn.fm/m7gvX. This TMP episode highlights an exclusive interview with Dr. Mari ...

NEW YORK, Dec. 4, 2024 /PRNewswire/ -- Today's Marketplace (TMP) is proud to announce a featured interview with Annovis' Founder, President and CEO, Maria Maccecchini, PHD, and Scott Shipman, MD, MPH, Executive Director for Creighton University's Institute for Population Health. Dr. Maccecchini and Dr. Shipman joined host Jane King to discuss clinical trials of a new drug that is showing promise for the treatment of neurodegenerative diseases like Alzheimer's and Parkinson's and their impact on population h ...

MALVERN, Pa., Nov. 25, 2024 (GLOBE NEWSWIRE) -- via IBN – Annovis Bio, Inc. (NYSE: ANVS), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases, is pleased to announce a live investor webcast scheduled for December 11, 2024, at 4:30 PM EST. Webcast Details: Date: December 11, 2024Time: 4:30 PM ESTRegistration Link: Register Here Dr. Maria Maccecchini, Founder, President, and CEO of Annovis, will lead the webcast, providing a comprehensive update on the company's re ...