- Annovis Bio recently filed three new patents covering combinations of buntanetap, its lead compound, with a GLP-1 agonist (such as dulaglutide/Trulicity) and with PDE5 inhibitors (such as sildenafil/Viagra), as well as a combination of all three
- The company believes these combinations create a broader approach to treating neurodegenerative diseases
- Preclinical studies have demonstrated these combinations significantly improve cognition in Alzheimer’s mouse models
- Combinations of buntanetap with PDE5 inhibitors and GLP-1 agonists are now ready to enter phase 3 clinical studies (buntanetap is in phase 3, and a number of PDE5 inhibitors and GLP-1 agonists are already on the market)
Annovis Bio (NYSE: ANVS), a late-stage clinical drug platform company developing transformative therapies for neurodegenerative disorders such as Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”), recently filed three new patents (https://ibn.fm/wWksA). The patent applications seek protection for innovative combination therapies involving buntanetap that improve cognition beyond normal levels.
Specifically, the patent filings cover buntanetap combined with a glucagon-like peptide-1 (“GLP-1”) agonist, buntanetap combined with a phosphodiesterase 5 (“PDE5”) inhibitor, and a combination of all three. According to the company, these combinations create a multi-sided approach to treating neurodegenerative diseases.
The motivation to seek patent protection stems from the successes of recent preclinical studies, which have provided compelling results that demonstrate the strong potential for the combinations to enhance cognition. Data from these studies have shown that buntanetap combined with PDE5 inhibitors or GLP-1 agonists improves cognitive function in Alzheimer’s mouse models beyond levels observed in healthy controls.
Maria Maccecchini, Ph.D., Founder, President and CEO of Annovis, noted, “Our early data suggests a strong synergistic effect from combining these drugs, resulting in significant cognitive enhancement.” Maria went on to state that the combination of buntanetap with Trulicity and Viagra has the potential to “restore cognition to healthy levels” and improve it “beyond normal level, offering new hope in the fight against dementia.”
According to an August 6 news release, buntanetap significantly amplifies the effects of Trulicity on memory and learning, leading to a “6- to 10-fold increase in efficacy,” according to Maria. The company observes that this synergy helps enhance treatment outcomes while simultaneously lessening potential side effects (https://ibn.fm/0zRY1).
Buntanetap targets neurodegeneration by inhibiting the production of various neurotoxic proteins, including TDP43, alpha-synuclein, tau, and amyloid beta. It improves the affected function in neurodegenerative diseases, enhances cognition in early AD patients, improves motor function and stops cognitive decline in PD patients.
The company’s recent Phase 2/3 study of buntanetap in patients with early (mild to moderate) AD showed a statistically significant improvement in cognition. The Phase 2/3 study gave the company valuable information for a planned Phase 3 pivotal trial (https://ibn.fm/sVv02). In addition, the company has separately completed a Phase 3 study of buntanetap in patients with early PD (https://ibn.fm/FIM3D).
“Since buntanetap has completed Phase 3 studies as a standalone treatment, and a number of GLP-1 agonists and PDE5 inhibitors are FDA-approved, these combinations are well positioned for Phase 3 human trials,” expressed Maria in the Sept. 30 news release announcing the patent filings.
The new patent applications are expected to further strengthen the company’s expansive intellectual property portfolio. Annovis currently has more than 35 total issued patents, plus plenty more pending applications in various jurisdictions, according to its latest Form 10-K filing (https://ibn.fm/YzxJB).
The issued patents and pending applications speak to the company’s resolve to “protect and enhance the proprietary technologies, inventions and improvements that we believe are important to our business, including seeking, maintaining and defending patent rights, whether developed internally or licensed from third parties,” as a source of its unique value to shareholders and competitive advantage.
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://ibn.fm/ANVS
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