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Annovis Reports New Biomarker Data Linking Amyloid Co-Pathology to Accelerated Cognitive Decline in Parkinson's Patients

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Annovis (NYSE: ANVS) reported Phase 3 data in early Parkinson's disease (NCT05357989) showing buntanetap halted cognitive decline across the study population and produced the largest benefit in patients with mild dementia.

Approximately 25% of participants had amyloid co-pathology and experienced accelerated cognitive decline that was reversed by buntanetap. Treatment also produced measurable reductions in plasma pTau217, total tau, and brain-derived tau, biomarkers linked to Alzheimer’s pathology.

Full biomarker data will be presented at CTAD in San Diego, December 1–4, 2025.

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Positive

  • Cognitive decline halted across overall Phase 3 early PD population
  • Subgroup with amyloid co-pathology had a three-times greater response
  • 25% of patients exhibited amyloid co-pathology
  • Measurable reductions in pTau217, total tau, and brain-derived tau

Negative

  • None.

News Market Reaction

+29.49% 95.1x vol
93 alerts
+29.49% News Effect
+61.9% Peak in 2 hr 21 min
+$24M Valuation Impact
$105M Market Cap
95.1x Rel. Volume

On the day this news was published, ANVS gained 29.49%, reflecting a significant positive market reaction. Argus tracked a peak move of +61.9% during that session. Our momentum scanner triggered 93 alerts that day, indicating high trading interest and price volatility. This price movement added approximately $24M to the company's valuation, bringing the market cap to $105M at that time. Trading volume was exceptionally heavy at 95.1x the daily average, suggesting very strong buying interest.

Data tracked by StockTitan Argus on the day of publication.

Buntanetap significantly improves cognition in all Parkinson’s patients, with those exhibiting Alzheimer’s co-pathology showing a three-times greater response

New data demonstrate reductions in plasma biomarkers pTau217, total tau, and brain-derived tau following buntanetap treatment

Findings support buntanetap's potential to address cognitive decline in Parkinson's disease, show disease-modifying efficacy, and inform future clinical development

MALVERN, Pa., Nov. 17, 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 new data demonstrating the impact of amyloid co-pathology on cognitive outcomes in Parkinson's patients and the therapeutic efficacy of buntanetap in this population.

In the Company’s Phase 3 study in early PD (NCT05357989), buntanetap halted cognitive decline across the overall patient population, with the greatest improvement observed in those with mild dementia. Further analysis revealed that approximately 25% of them exhibited amyloid co-pathology and experienced more pronounced cognitive decline over the course of the study, which was counteracted and reversed by buntanetap.

These findings reinforce a central principle long championed by Annovis: neurodegenerative diseases rarely occur in isolation. Instead, multiple neurotoxic proteins—those implicated in both Alzheimer’s and Parkinson’s—drive cognitive and functional decline. Addressing this complexity requires therapies capable of targeting several toxic proteins simultaneously, which is precisely what buntanetap does.

As anticipated, buntanetap treatment led to significant cognitive improvement in Parkinson’s patients with amyloid co-pathology. This response was further supported by measurable reductions in pTau217, total tau, and brain-derived (BD) tau – well-established biomarkers of neurodegeneration used in AD. Together, these findings indicate that buntanetap is actively modulating the underlying drivers of cognitive deterioration, ultimately broadening the population of patients who may benefit from treatment.

"What we see is that Parkinson's patients who experience cognitive decline also have Alzheimer's pathology, and our drug helps them," commented Cheng Fang, Senior VP, Research & Development. "These data are the first of its kind—no one has previously looked into treatment effects in Parkinson's patients with amyloid co-pathology. The findings integrate seamlessly with our growing body of clinical evidence, distinguishing buntanetap as a promising therapeutic candidate for cognitive improvement across multiple neurodegenerative diseases."

The full biomarker data will be presented at the Clinical Trials on Alzheimer's Disease (CTAD) conference in San Diego, December 1-4, 2025. Additional details regarding the presentation will be announced closer to the conference date via a separate news release.

About Annovis
Headquartered in Malvern, Pennsylvania, Annovis is dedicated to addressing neurodegeneration in diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD). The Company is committed to developing innovative therapies that improve patient outcomes and quality of life. For more information, visit www.annovisbio.com and follow us on LinkedInYouTube, and X.

Investor Alerts
Interested investors and shareholders are encouraged to sign up for press releases and industry updates by registering for email alerts at https://www.annovisbio.com/email-alerts.

Forward-Looking Statements
This press release contains forward-looking statements under the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended. Actual results may differ due to various risks and uncertainties, including those outlined in the Company’s SEC filings under “Risk Factors” in its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update forward-looking statements except as required by law.

Contact Information:
Annovis Bio Inc.
101 Lindenwood Drive
Suite 225
Malvern, PA 19355
www.annovisbio.com

Investor Contact:
Alexander Morin, Ph.D.
Director, Strategic Communications
Annovis Bio
ir@annovisbio.com


FAQ

What did Annovis (ANVS) announce about buntanetap in Parkinson's disease on November 17, 2025?

Annovis announced Phase 3 data showing buntanetap halted cognitive decline overall and reversed decline in patients with amyloid co-pathology.

How many Parkinson's patients in the ANVS study had amyloid co-pathology?

About 25% of participants in the Phase 3 early PD study exhibited amyloid co-pathology.

What biomarker changes did Annovis report for buntanetap in the ANVS Phase 3 PD study?

The company reported measurable reductions in plasma pTau217, total tau, and brain-derived tau following treatment.

How did amyloid co-pathology affect treatment response in the ANVS Phase 3 study?

Patients with amyloid co-pathology showed a roughly three-times greater cognitive response to buntanetap compared with others.

When and where will Annovis present the full biomarker data for ANVS?

Full biomarker data will be presented at CTAD in San Diego, December 1–4, 2025.
Annovis Bio Inc

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Biotechnology
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United States
MALVERN