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Annovis Bio Inc. (NYSE: ANVS) Announces Encouraging Clinical Trial Results, IP Portfolio Enhancement

  • The company has released key corporate and business updates and Q2 2024 financial results
  • Clinical trials for both Alzheimer’s and Parkinson’s studies yielded encouraging data for lead compound buntanetap
  • Buntanetap in combination with GLP-1 agonist dulaglutide Trulicity(R) showed increased potential to synergistically enhance cognition
  • The company has obtained a patent and begun manufacturing of a new crystalline form of buntanetap, with improved properties

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”), offered key business updates and announced financial results for the second quarter ended June 30, 2024. The company reported productive recent months, with encouraging data on lead compound buntanetap’s performance in two pivotal studies, according to Maria Maccecchini, Ph.D., Founder, President, and CEO (https://ibn.fm/hc6L4).

“We’ve completed pivotal Phase 2/3 Alzheimer’s and Phase 3 Parkinson’s studies, both of which revealed very encouraging data for buntanetap,” Maccecchini said. Buntanetap works by targeting multiple pathways involved in neurodegenerative diseases. It inhibits the production of neurotoxic proteins that lead to the death of neurons, thereby slowing or stopping disease progression.

Alzheimer’s Disease Clinical Trial:

Data from a Phase 2/3 AD study was released on April 29, showing that buntanetap significantly improved cognition in patients with early AD, with 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.

A later analysis on June 11 demonstrated that buntanetap was effective in improving cognition among high-risk APOE4 carriers, showing a 3.15-point improvement. It also showed that buntanetap was as safe in APOE4 carriers as non-carriers, a huge advantage over existing disease-modifying therapies.

Parkinson’s Disease Clinical Trial:

Data from a Phase 3 PD clinical trial was released on July 2, indicating that buntanetap led to significant improvements in both the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) and cognition across several PD subpopulations.

Buntanetap showed a strong response in individuals diagnosed with PD for more than three years as well as in those with postural instability and gait disorder (“PIGD”). The lead compound was also found to halt cognitive decline in all enrolled patients and improved cognition in those with mild dementia.

Combination Trial with GLP-1 Agonist Dulaglutide:

On August 6, Annovis Bio released preclinical data demonstrating that its lead compound, buntanetap, synergistically enhances  cognition beyond normal levels, when used in combination with the glucagon-like peptide 1 (GLP-1) agonist dulaglutide (Trulicity(R)) in a mouse model of AD.

New Patents:

The company introduced a new crystalline form of buntanetap with improved properties, further strengthening its IP portfolio. The new crystalline form offers significant advantages over the less structured, old semi-crystalline form, including better solubility and stability as well as an additional 20 years of patent life.

Annovis Bio filed a provisional patent for the manufacturing of this crystalline form.

The company was also granted a patent from the US patent office for using buntanetap for acute traumatic brain injury treatment. The company now has worldwide rights for buntanetap in acute neurodegeneration.

The company received approval from the Food and Drug Administration to continue the development of this new form of buntanetap.

“These milestones position us strongly as we move closer to providing much-needed treatments to patients,” Dr. Maccecchini said, commenting on the business updates.

These encouraging results will enable the company to capture a significant share of the neurodegenerative disease treatment market, an expanding sector driven by an aging population and increasing incidence of conditions like AD. Alzheimer’s care costs are expected to reach $360 billion in 2024 and grow to nearly $1 trillion annually by 2050 (https://nnw.fm/bB6Wi). (https://ibn.fm/3EpPm).

For more information, visit the company’s website at www.AnnovisBio.com, and social channels
LinkedInX 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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