Breakthrough Clinical Results

ZIVO Bioscience announced positive results from a University of Delaware study evaluating its algal-derived ingredients to mitigate avian influenza in poultry. The study identified an optimal formulation that showed a slower spread of the virus in contact-exposed birds, with one bird showing no infection. While results in directly challenged birds didn't reach statistical significance, positive trends were observed. ZIVO is seeking funding to further research this promising, sustainable, non-antibiotic solution for the poultry industry, aiming to address the widespread issue of avian influenza.

Emerging Mechanism of Action

Avian influenza, a significant threat to both animal and human health, requires a multifaceted approach to combat its emergence and spread. Based on recent PubMed publications, several key mechanisms of action (MoAs) are emerging:

1. Enhanced Surveillance and Diagnostic Technologies:

• Advanced surveillance systems are crucial for tracking the changing epidemiology of avian influenza viruses. This includes monitoring both bird and mammal populations for the emergence of novel strains and subtypes.
• Rapid and accurate diagnostic tests are essential for timely detection of avian influenza infections in humans. Multiplex assays that can simultaneously detect influenza viruses and other respiratory pathogens like SARS-CoV-2 are particularly valuable.
• State-of-the-art analysis methods, such as genomic sequencing and phylogenetic analysis, are used to track the evolution and spread of avian influenza viruses, identify mutations associated with increased virulence or transmissibility, and inform vaccine development.

2. One Health Approach:

• The One Health approach recognizes the interconnectedness of human, animal, and environmental health. It emphasizes the need for interdisciplinary collaboration to address complex health challenges like avian influenza.
• Key components of the One Health approach for avian influenza include enhanced surveillance, tightened biosecurity measures on poultry farms, targeted vaccination of poultry, timely precautions to prevent human infections, and timely clinical management of infected individuals.
• Global collaboration is essential for sharing information, coordinating surveillance efforts, and developing and deploying effective interventions.

3. Vaccination Strategies:

• Annual influenza vaccination remains the primary preventive measure against seasonal influenza. Efforts are underway to develop new and improved vaccines with broader and longer-lasting protection.
• Next-generation influenza vaccines aim to induce broader and longer-lasting immune responses to overcome antigenic drift and address the emergence of pandemic strains. These include vaccines based on conserved viral antigens, such as the viral hemagglutinin (HA) stalk, which are less prone to antigenic variation.
• Targeted vaccination of poultry is an important strategy for controlling avian influenza in bird populations and reducing the risk of spillover to humans.

4. Antiviral Therapies:

• Neuraminidase inhibitors, such as oseltamivir and zanamivir, are currently the mainstay of antiviral treatment for influenza. However, resistance to these drugs can emerge, highlighting the need for new therapeutic options.
• Polymerase inhibitors, a newer class of antivirals, show promise in treating influenza infections and may offer an alternative to neuraminidase inhibitors.
• Research is ongoing to develop new antiviral drugs that target other viral proteins or host factors involved in influenza virus replication.

5. Non-Pharmaceutical Interventions:

• Non-pharmaceutical interventions (NPIs), such as hand hygiene, respiratory etiquette, and social distancing, can help to reduce the spread of influenza viruses.
• NPIs were widely implemented during the COVID-19 pandemic and likely contributed to the marked decline in influenza activity observed during that period.
• These measures can be effective in mitigating the impact of both seasonal and pandemic influenza.

Drug used in other indications

ZIVO's proprietary active ingredient, derived from the algae Klebsormidium flaccidum var. ZIVO and marketed as KALGAE, is primarily positioned as a plant-based protein source for human and animal consumption. The provided text focuses on safety and toxicity studies conducted on rats to support its use as a food ingredient. There is no mention of trials involving Avian Influenza or any other disease treatment using KALGAE.

The available information pertains to:

• Safety and Toxicity: Studies in rats demonstrated no adverse effects at high dietary concentrations of KALGAE, establishing a No Observable Adverse Effect Level (NOAEL). These studies included assessments of body weight, food consumption, hematology, clinical chemistry, urinalysis, organ weights, and histopathology. Genotoxicity studies also indicated KALGAE was non-mutagenic.

Therefore, based on the provided information, KALGAE is not currently being trialled for Avian Influenza or any other therapeutic indication. Its current application is focused on its nutritional value as a protein source, supported by safety and toxicity data.

Company drugs in pipeline

ZIVO Bioscience, Inc. focuses on developing products derived from Klebsormidium flaccidum var. zivo, a green alga. Their research and development efforts are not centered around traditional drug development pipelines like those for pharmaceuticals. Instead, they concentrate on applications in the following areas:

• Animal Feed and Aquaculture: ZIVO's primary focus is on using K. flaccidum biomass as a functional ingredient in animal feed and aquaculture. Studies have investigated its safety and potential as a protein source for livestock and fish. (Source: https://pubmed.ncbi.nlm.nih.gov/30294555/)

• Human Nutrition: While not a drug, K. flaccidum is being explored as a potential source of protein and other nutrients for human consumption. Its safety as a food ingredient has been evaluated. (Source: https://pubmed.ncbi.nlm.nih.gov/30294555/)

• Anti-inflammatory Compounds: Research has identified bioactive compounds within K. flaccidum, such as pheophorbide a, with anti-inflammatory properties. These compounds are not currently being developed as drugs in the traditional sense but are being investigated for their potential health benefits. (Source: https://pubmed.ncbi.nlm.nih.gov/32110943/)

It's important to note that ZIVO Bioscience is not a traditional pharmaceutical company developing drugs for specific disease indications. Their work centers around utilizing the properties of K. flaccidum for animal and human nutrition and exploring potential health-promoting applications of its bioactive components.