Annovis Bio Inc. (NYSE: ANVS) Announces New Data From Phase III Study of Buntanetap for Early Parkinson’s Disease

• The study shows buntanetap is effective in enhancing both motor and cognitive functions, as well as non-motor activities in Parkinson’s Disease patients
• Following the announcement of these positive results, the company’s stock price surged by 76%
• The data revealed that while 12% of Parkinson’s Disease patients showed cognitive decline, buntanetap not only halted this decline but also led to improvements
• Annovis held a webcast to go over the results in more depth, which is available for replay on the company’s website

Annovis Bio (NYSE: ANVS), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative disorders such as Alzheimer’s Disease and Parkinson’s Disease, has released new data from its Phase III study of buntanetap for early Parkinson’s Disease. The study shows buntanetap is effective in enhancing both motor and cognitive functions, as well as non-motor activities in Parkinson’s Disease patients (https://ibn.fm/5ZqlC).

Following the announcement of these positive results, the company’s stock price surged by 76%. This remarkable increase reflects strong investor confidence in buntanetap’s potential to address critical unmet needs in neurodegenerative disease treatment (https://ibn.fm/ZctmR). The trial results highlighted notable improvements in motor and cognitive functions, particularly in patients diagnosed for more than three years and those with postural instability and gait difficulty.

Key findings from the study include:

• Cognitive Benefits: Buntanetap demonstrated a significant effect in halting cognitive decline among all participants with MMSE scores of 20-30. In patients with mild dementia (MMSE 20-26), cognitive deterioration was slower in the placebo group compared to those receiving 10mg of Buntanetap. Additionally, those treated with 20mg showed significant cognitive improvements over placebo.
• Motor and Non-Motor Function: The drug showed notable improvements in motor and non-motor Parkinson’s Disease-related functions, particularly in patients diagnosed for over three years. These improvements were significant across various measures, including MDS-UPDRS Part II, Part III, Part II+III, and Total scores.
• Postural Instability and Gait Difficulty (“PIGD”): Patients with PIGD, who typically experience faster disease progression, responded exceptionally well to buntanetap. Significant improvements were seen in MDS-UPDRS Part II, Part III, Part II+III, and Total scores.

Participants were selected based on MMSE scores between 20-30, with these scores re-evaluated at the study’s conclusion. The data revealed that while 12% of Parkinson’s Disease patients showed cognitive decline (MMSE 20-26), buntanetap not only halted this decline but also led to improvements.

Buntanetap’s safety profile remained consistent across all participant groups, with no notable differences between those with early and advanced Parkinson’s Disease. This aligns with previous safety data from Alzheimer’s Disease studies.

Initially, the primary endpoint was MDS-UPDRS Part II+III. However, after feedback from the FDA, the focus shifted to MDS-UPDRS Part II alone, considered more relevant for assessing clinically meaningful changes. Consequently, MDS-UPDRS Part III was designated a secondary endpoint. Buntanetap successfully met both primary and secondary endpoints in specific patient subgroups.

“We are very pleased to see improvements in many of our patients over such a short course of treatment,” said Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis. “These compelling data reinforce our commitment to advancing buntanetap into a longer study, which will allow us not only to verify observed symptomatic improvements but also to explore buntanetap’s disease-modifying properties.”

Annovis Bio also hosted an investor webcast on July 2, 2024, to provide more information and deeper insight into the study’s findings. Interested parties are encouraged to watch a replay of the webcast (https://ibn.fm/Ut4B5).

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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