- Annovis announced in June 2024 that they had filed a composition of matter patent for their new crystal form of buntanetap, along with a provisional patent for the manufacturing process
- The company’s goal is to use this technology to restore brain function and improve the quality of life for patients dealing with neurodegenerative disease such as Alzheimer’s disease
- The worldwide market for Alzheimer’s disease modifying drugs, versus symptomatic drugs, could approach $30 billion by 2030
Annovis Bio (NYSE: ANVS), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative disorders like Alzheimer’s and Parkinson’s, just announced that the U.S. Food and Drug Administration (“FDA”) has given approval for Annovis to switch to a new solid form of buntanetap for their future clinical trials (https://ibn.fm/KfHve).
In June 2024, Annovis announced they had filed a composition of matter patent for their new crystal form of buntanetap, along with a provisional patent for the manufacturing process. To reach this milestone, they conducted extensive bridge studies comparing the old semi-crystalline form with the new crystalline form in various solvents and animals. Additionally, they developed an innovative large-scale manufacturing process for the new form and submitted all this data to the FDA for review.
In a previous press release, Maria Maccecchini, Ph.D., Founder and President of Annovis said the invention of a new solid form of buntanetap and the subsequent patent filing represent groundbreaking milestones for the company. “This achievement will allow us not only to continue advancing our pipeline, but also to enhance the drug’s properties, ultimately providing greater benefits to our patients,” Maccecchini added.
With the FDA’s approval, Annovis can now move forward with their plans. They will conduct a small, single-dose study in humans to compare the old and new forms of buntanetap and assess their effectiveness.
According to a Fortune Business Insights report, the global Alzheimer’s drugs market size was valued at USD 3.52 billion in 2022 and is projected to grow from USD 3.69 billion in 2023 to USD 5.21 billion by 2030, exhibiting a CAGR of 5.1% during the forecast period (https://ibn.fm/DXKAV). However, for actual Alzheimer’s disease modifying drugs, versus symptomatic drugs, the worldwide market could approach $30 billion by 2030.
Buntanetap, known as Posiphen, is Annovis Bio’s leading candidate in the fight against neurodegeneration. It works by blocking the production of several neurotoxic proteins – amyloid beta, tau, alpha-synuclein, and TDP43. These proteins can cause significant issues for nerve cells, including impaired synaptic transmission and axonal transport, neuroinflammation and cell death.
By targeting these harmful proteins, buntanetap aims to reverse the damage caused by neurodegenerative diseases such as Alzheimer’s and Parkinson’s. The goal is to restore brain function and improve the quality of life for patients facing these challenging conditions.
“As we continue to advance our pipeline, securing our manufacturing rights for new forms of buntanetap is vital,” said Michael Christie, Ph.D., Vice President of Process Chemistry. “This ensures we maintain control over the production process, protect our intellectual property, and continue our mission to deliver novel therapeutics for patients suffering from neurodegenerative disorders.”
Annovis Bio is dedicated to improving the lives of patients with neurodegenerative diseases. Their mission is to find ways to slow down, stop, or even reverse the progression of these diseases. They are in the late stages of developing new therapies that could be transformative for patients and their families. With the FDA’s latest approval, Annovis is one step closer to bringing their innovative treatments to those in need.
For more information, visit the company’s website at 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://ibn.fm/ANVS
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