Annovis Bio Inc. (NYSE: ANVS) Gets FDA Clearance f
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Posted On: 10/25/2024 4:48:00 PM
Annovis Bio Inc. (NYSE: ANVS) Gets FDA Clearance for Buntanetap Pivotal Phase 3 Trials, Market Enthusiasm Highlighted in GuruFocus Article
- Financial research platform GuruFocus underlines Annovis’ unique approach to tackling neurodegenerative conditions such as Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”).
- The FDA’s decision to allow the company to go to Phase 3, points to the fact that lead drug candidate buntanetap may be an effective treatment for AD, one of the most critical diseases in an aging society.
- Buntanetap has been shown to significantly improve cognition in early AD patients, both by itself or on top of existing therapies.
- The Phase 3 program will consist of two trials: a 6-month study aimed at confirming buntanetap’s symptomatic benefits and an 18-month study to explore potential disease-modifying effects.
- Annovis plans to initiate the first trial in Q1 2025, with the possibility of submitting an NDA based on the completion of the 6-month study.
Annovis Bio (NYSE: ANVS), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”), recently secured the approval of the U.S. Food and Drug Administration (“FDA”) to pursue Phase 3 clinical trials for lead Alzheimer’s drug candidate buntanetap. This important milestone, along with recent stock developments and the company’s likely future, were highlighted in an article on financial research platform GuruFocus (https://nnw.fm/DnGkp ).
“The market is enthusiastic to Annovis Bio, Inc. and some say that they tackle Alzheimer’s and Parkinson’s in ways humanity has never achieved before,” the article says, emphasizing that buntanetap was reported to do well in Phase 2a and 2/3 trials, indicating improvement in Alzheimer’s patients.
“The FDA’s action to allow the company to go to Phase 3 is a positive point to the fact that buntanetap may be an effective cure for this disease that ravages the lives of so many people,” the article also says.
The GuruFocus piece also underlines that the future of Annovis is wide open because its drug targets Alzheimer’s and other neurodegenerative diseases that affect millions of families in the U.S. and worldwide.
Buntanetap works by lowering levels of multiple neurotoxic proteins that are responsible for multiple pathways involved in neurodegenerative diseases. A recent Phase 2/3 study showed that buntanetap exhibited significant cognitive improvements in early Alzheimer’s patients, while maintaining a strong safety profile. This trial involved 353 patients and assessed buntanetap’s efficacy and safety on top of standard-of-care medications. Study results showed a 3.3-point improvement on the ADAS-Cog11 test after three months of treatment, compared to a 0.3-point improvement in the placebo group.
After a successful end-of-Phase 2 meeting with the FDA, the company was cleared to start two pivotal Phase 3 studies for buntanetap in early-stage Alzheimer’s patients and agreed on the next steps to advance toward a New Drug Application submission.
The Phase 3 trial will consist of two studies – a 6-month study aimed at confirming buntanetap’s symptomatic benefits and an 18-month study to explore potential disease-modifying effects. Annovis plans to initiate the first trial in Q1 2025, with the possibility of submitting an NDA based on the completion of the 6-month study (https://nnw.fm/eOZg5 ).
“We are grateful for the FDA’s support in advancing our Phase 3 studies in early AD patients as planned,” said Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis Bio. “This clearance marks an important step forward as we work to bring buntanetap to patients in need. Our team is preparing to launch the study early next year, and we will provide ongoing updates as we progress towards our goals.”
For more information about the company, visit www.AnnovisBio.com, and social channels LinkedIn, X and YouTube.
NOTE TO INVESTORS: The latest news and updates relating to ANVS are available in the company’s newsroom at https://nnw.fm/ANVS
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
- Financial research platform GuruFocus underlines Annovis’ unique approach to tackling neurodegenerative conditions such as Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”).
- The FDA’s decision to allow the company to go to Phase 3, points to the fact that lead drug candidate buntanetap may be an effective treatment for AD, one of the most critical diseases in an aging society.
- Buntanetap has been shown to significantly improve cognition in early AD patients, both by itself or on top of existing therapies.
- The Phase 3 program will consist of two trials: a 6-month study aimed at confirming buntanetap’s symptomatic benefits and an 18-month study to explore potential disease-modifying effects.
- Annovis plans to initiate the first trial in Q1 2025, with the possibility of submitting an NDA based on the completion of the 6-month study.
Annovis Bio (NYSE: ANVS), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”), recently secured the approval of the U.S. Food and Drug Administration (“FDA”) to pursue Phase 3 clinical trials for lead Alzheimer’s drug candidate buntanetap. This important milestone, along with recent stock developments and the company’s likely future, were highlighted in an article on financial research platform GuruFocus (https://nnw.fm/DnGkp ).
“The market is enthusiastic to Annovis Bio, Inc. and some say that they tackle Alzheimer’s and Parkinson’s in ways humanity has never achieved before,” the article says, emphasizing that buntanetap was reported to do well in Phase 2a and 2/3 trials, indicating improvement in Alzheimer’s patients.
“The FDA’s action to allow the company to go to Phase 3 is a positive point to the fact that buntanetap may be an effective cure for this disease that ravages the lives of so many people,” the article also says.
The GuruFocus piece also underlines that the future of Annovis is wide open because its drug targets Alzheimer’s and other neurodegenerative diseases that affect millions of families in the U.S. and worldwide.
Buntanetap works by lowering levels of multiple neurotoxic proteins that are responsible for multiple pathways involved in neurodegenerative diseases. A recent Phase 2/3 study showed that buntanetap exhibited significant cognitive improvements in early Alzheimer’s patients, while maintaining a strong safety profile. This trial involved 353 patients and assessed buntanetap’s efficacy and safety on top of standard-of-care medications. Study results showed a 3.3-point improvement on the ADAS-Cog11 test after three months of treatment, compared to a 0.3-point improvement in the placebo group.
After a successful end-of-Phase 2 meeting with the FDA, the company was cleared to start two pivotal Phase 3 studies for buntanetap in early-stage Alzheimer’s patients and agreed on the next steps to advance toward a New Drug Application submission.
The Phase 3 trial will consist of two studies – a 6-month study aimed at confirming buntanetap’s symptomatic benefits and an 18-month study to explore potential disease-modifying effects. Annovis plans to initiate the first trial in Q1 2025, with the possibility of submitting an NDA based on the completion of the 6-month study (https://nnw.fm/eOZg5 ).
“We are grateful for the FDA’s support in advancing our Phase 3 studies in early AD patients as planned,” said Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis Bio. “This clearance marks an important step forward as we work to bring buntanetap to patients in need. Our team is preparing to launch the study early next year, and we will provide ongoing updates as we progress towards our goals.”
For more information about the company, visit www.AnnovisBio.com, and social channels LinkedIn, X and YouTube.
NOTE TO INVESTORS: The latest news and updates relating to ANVS are available in the company’s newsroom at https://nnw.fm/ANVS
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
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