Beyond the Horizon: Innovative Drug Combinations Offer New Hope for Alzheimer’s and More

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New York, NY – October 3, 2024 – Pharmaceutical companies are demonstrating innovation by not only developing new drugs but also exploring combination therapies and repurposing existing drugs to address unmet medical needs. This strategic approach holds promise for providing hope to millions of patients suffering from historically challenging diseases. Alzheimer’s disease (AD) for example, has become a focal point of this innovation, with recent U.S. Food and Drug Administration (FDA) approvals of Leqembi and Kisunla — although these treatments only slow cognitive decline rather than improve cognitive function. New uses for approved glucagon-like peptide-1 (GLP-1) and phosphodiesterase 5 (PDE5) inhibitor drugs show promise in treating Alzheimer’s, with companies such as Annovis Bio Inc. (NYSE: ANVS) (profile) leading the way with treatments ready for late-stage clinical trials. Beyond Alzheimer’s, the pharmaceutical industry is experiencing a surge of innovation across various disease areas. Major players, including Johnson & Johnson (NYSE: JNJ), Novartis (NYSE: NVS), Merck & Co. Inc. (NYSE: MRK) and GSK plc (NYSE: GSK) are at the forefront of medical innovation, tackling previously intractable diseases.

• Annovis is leading the way in the development of buntanetap, currently testing the drug in pivotal clinical trials for Alzheimer’s and Parkinson’s diseases.
• The company has secured intellectual property for innovative combination therapies involving buntanetap and other drugs, including Trulicity(R) and Viagra(R), which work together to enhance cognitive function.
• Annovis’ planned phase 3 studies may evaluate both double combinations (buntanetap with GLP-1 agonist or PDE5 inhibitor) and a triple combination of all three drugs.

Click here to view the custom infographic of the Annovis Bio editorial.

Buntanetap Targeting Alzheimer’s Disease

 

Annovis Bio Inc. (NYSE: ANVS) is leading efforts to develop innovative and safe treatments for neurodegenerative diseases such as Alzheimer’s. The company’s main focus is enhancing nerve cell health to improve cognition in such conditions, a target that has proved elusive for peers. The company’s flagship drug candidate, buntanetap, has completed advanced-stage clinical trials for both AD and Parkinson’s disease (PD) and has shown compelling results in both indications.

Earlier in the year, Annovis shared positive data from a phase 2/3 trial evaluating buntanetap as an oral therapy for early-stage AD. This trial, which included 353 participants, assessed both the drug’s effectiveness alongside standard care, as well as providing insight on the safety profile. The results demonstrated cognitive improvements across all doses compared to placebo, with the 30mg dose showing the greatest benefit, measured by the ADAS-Cog 11 scale. These findings aligned with prior studies (NCT04524351, NCT02925650), with buntanetap also reducing key disease biomarkers including neurofilament light (NFL), tau protein and the inflammatory biomarker glial fibrillary acidic protein (GFAP). Annovis is currently planning for a confirmatory phase 3 trial in biomarker-positive early AD patients to support an anticipated New Drug Application (NDA) submission.

Recently, Annovis expanded its approach by exploring combinations of buntanetap with drugs such as Trulicity (dulaglutide) and Viagra (sildenafil), either as individual combination therapies or a three-prong approach utilizing all for their unique strengths. The three drugs bring their own strengths to the combination table. Trulicity, a popular GLP-1 agonist, has been shown to improve brain glucose metabolism. Viagra is known to enhance cerebral blood flow. Buntanetap inhibits the production of neurotoxic proteins, including amyloid beta, tau, alpha-synuclein and TDP-43, and improves the flow of information, offering a potential to restore cognitive function in patients.

Next-Generation AD Opportunity

Annovis recently unveiled preclinical data demonstrating that combining buntanetap with Trulicity in an Alzheimer’s mouse model yielded synergistic benefits. While both drugs individually improved cognitive function, their combined impact surpassed that of healthy controls by 16%, reinforcing the potential of combination therapies for AD treatment.

It is theorized that the improvement as a combination is undergirded by the neurotoxic inhibiting attributes of buntanetap paired with Trulicity’s ability to penetrate the blood-brain barrier and normalize glucose metabolism. This groundbreaking research marks the first instance of a treatment restoring cognitive function beyond normal levels.

“We are excited to see that buntanetap significantly amplifies the effects of dulaglutide on memory and learning, with a 6- to 10-fold increase in efficacy,” said Annovis Bio founder, president and CEO Maria Maccecchini, PhD, regarding the study results.

A Fresh Perspective on an Old Problem

The fight against neurodegenerative disease potentially could get a boost from unexpected sources, as drugs traditionally used for diabetes and erectile dysfunction (ED) are used for AD.

GLP-1 Agonists

Originally designed to treat type 2 diabetes, these drugs (such as semaglutide and liraglutide) mimic a hormone that regulates blood sugar. While helping diabetics control glucose, researchers noticed an additional benefit: significant weight loss. This led to the approval of drugs such as Wegovy for obesity treatment that act by suppressing appetite and increasing fat burning.

The benefits do not stop there. Recent studies suggest GLP-1 drugs may also reduce the risk of heart disease, kidney disease and stroke, and even possibly protect the brain from AD by reducing inflammation, improving brain’s insulin sensitivity and enhancing neuroplasticity (the brain’s ability to form new connections).

Early clinical trials are promising. Mid-stage data showed Liraglutide (Victoza), a GLP-1 drug, to significantly minimized brain shrinkage in memory, learning and language areas compared to a placebo.

PDE5 Inhibitors

These medications (such as Viagra and Cialis), known for treating ED where smooth muscle contraction is paramount, are also being explored for AD. Although commonly used for their blood pressure-lowering effects, preclinical studies suggest they can improve synaptic function (communication between brain cells) and cerebral blood flow while also enhancing cognitive abilities. Currently, four oral PDE5 inhibitors are available in the United States: sildenafil (Viagra(R), Pfizer), vardenafil (Levitra/Staxyn(R), Bayer), tadalafil (Cialis(R), Eli Lilly), and avanafil (Stendra(R), Vivus).

Real-world data also paints a hopeful picture. Notably, sildenafil (Viagra) is linked to a reduced risk of dementia in patients who take it. Cleveland Clinic-led research discovered that in Alzheimer’s patients, sildenafil reduces levels of neurotoxic tau proteins, known contributors to the disease. Additionally, neurons treated with sildenafil exhibited enhanced cell growth, improved brain function and reduced inflammation, all of which are crucial for protecting against the neural degeneration associated with Alzheimer’s.

This promising research suggests both GLP-1 agonists and PDE5 inhibitors could have a neuroprotective effect, offering a new approach to combatting AD. By targeting the disease from multiple angles, these drugs hold potential for a more holistic treatment strategy.

Growing Patent Estate

Annovis has taken a proactive step to protect its intellectual property by filing three new patents for innovative combination therapies involving buntanetap. These patents encompass combinations with Trulicity and Viagra, as well as a synergistic approach using all three drugs. The combination of these drugs provides a competitive advantage to Annovis insomuch that buntanetap has completed phase 3 studies as a standalone treatment and the others are already FDA approved. To wit, Annovis is well positioned to initiate phase 3 clinical studies.

Further, this multifaceted approach offers unprecedented potential in combating neurodegeneration, especially considering the growing prevalence of AD in the U.S. Neurodegenerative diseases are on the rise, with Alzheimer’s affecting nearly 6.7 million Americans today. Without significant medical breakthroughs, this number is projected to double to 13.8 million by 2060. With buntanetap already completing phase 3 trials and Trulicity and Viagra being FDA approved, these combination therapies are well positioned for further clinical development under the protection of Annovis’ patents.

Other Innovators

A wave of innovative treatments is emerging, offering hope for patients with previously challenging conditions. The outlook is brightening as promising therapies are being developed, paving the way for a brighter future in healthcare.

Johnson & Johnson (NYSE: JNJ), a multinational pharmaceutical, biotechnology, and medical technologies corporation, is focused on healthcare innovation that builds a world where complex diseases are prevented, treated and cured; and where treatments are smarter and less invasive; and solutions are personal. Most recently the company invested more than $2 billion in new, advanced technology manufacturing facility in North Carolina to support robust portfolio growth. The new facility will expand production of Johnson & Johnson’s innovative biologic medicines in areas including oncology, immunology, and neuroscience; construction on the state-of-the-art structure is slated to begin in the first half of 2025.

Novartis (NYSE: NVS) is an innovative medicines company with research and development at its core. The company’s R&D engine powers an industry-leading pipeline that is focused on delivering transformative medicines to fight disease, restore possibility and help people live life on their own terms. The company’s researchers work across several diseases areas to drive drug discovery and early development, while its development organization leads the advanced clinical development of those medicines. This work is powered by technology platforms that help the company innovate across its core therapeutic areas: cardiovascular, renal and metabolic, oncology, immunology and neuroscience.

Merck & Co. Inc. (NYSE: MRK) is developing an investigational GLP-1/glucagon receptor co-agonist: efinopegdutide (MK-6024). The experimental drug efinopegdutide, which is being developed as a treatment for nonalcoholic steatohepatitis (NASH) and was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for this treatment, also showed a weight-loss benefit, said CEO Robert Davis during the 45th Annual Goldman Sachs Healthcare Conference.

GSK plc (NYSE: GSK) was at this year’s Alzheimer’s Association International Conference, presenting four new abstracts contributing to early science in neurodegenerative diseases. More specifically, GSK was presenting results from the ZOSTER-122 retrospective, observational matched-cohort study in adults aged 50 years and over, which examines the potential association between Shingrix (Recombinant Zoster Vaccine or RZV) vaccination and reduced risk of dementia compared to two other vaccines.

These pharmaceutical players are working to find effective treatments for diseases that for decades have been underserved. Potential breakthroughs in the development of new drugs could mean big success for these companies and, even more important, significant benefits for the individuals suffering from these diseases.

For more information about Annovis Bio Inc. (NYSE: ANVS), please visit Annovis Bio Inc.

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