Enzolytics Inc. is a drug development company committed to the commercialization of its multiple proprietary therapeutics for the treatment of debilitating infectious diseases. The Company's proprietary technologies include therapeutics for treating HIV and monoclonal antibodies for infectious diseases including HIV, SARS-CoV-2, and numerous other viruses in both humans and animals, and the production of over-the-counter nutritional supplements. Planned Expansion of the Company's Monoclonal Antibodies. Enzolytics is focused on the production of anti-HIV therapeutics and monoclonal antibodies to treat viruses that affect humans. At the same time, the Company is applying its technology to address viruses that affect animals. The Company's primary therapeutics in progress include the following. ITV-1 anti-HIV Therapeutic: ITV-1 is an anti-HIV therapeutic produced under patents invented by the Company's CSO, Harry Zhabilov, U.S. Patent Nos. 8,066,982 and 7,479,538. These and all patents relating to all Company technologies and products are exclusively licensed to the Company. No other company or individual has an ownership right or license in any Company related patent. Patent Office records verify this fact. The Company has announced the completion of the first phase of the animal toxicology studies on its ITV-1 anti-HIV therapeutic and continues to progress with the GLP Compliant Repeat Dose Toxicity study. Upon completion of final Toxicity Study by BTS Pharma under GLP conditions, the Company expects to be able to make ITV-1 available in the countries in Africa, including Rwanda, the Democratic Republic of Congo, Angola, Kenya, and South Africa. The Company sees this as significant for individuals in Africa recognizing that out of the 34 million HIV-positive people worldwide, 69% live in sub-Saharan Africa. There are roughly 23.8 million infected persons in all of Africa. 40% of those infected with HIV in Africa do not have any access to any treatment for the virus. In addition, 91% of the world's HIV-positive children are in Africa. Prior successful Clinical Trials of the Company's ITV-1 treatment were completed earlier under the Bulgarian Drug Agency requirements. The Company moving forward to complete further clinical trials to fulfill the European Medicines Agency (EMA) requirements to launch the therapy in the EU followed by seeking FDA approval for use in North America. The Company is finalizing a comprehensive clinical development plan based on the prior clinical trials completed earlier, preparing a CMC non-clinical Gap analysis, and a necessary EU Regulatory Strategy. Thereafter, CMC and GMP Requirements for EMA and FDA will be completed, followed by production of ITV-1 as per EMA and FDA requirements and a Fast-Tracked Clinical Trial to fulfill EMA and FDA requirements. ITV-1 has been successfully produced and has been earlier successfully clinically tested in human trials under the Bulgarian Drug Agency requirements. In the prior clinical trials of ITV-1, the following beneficial results were established: ITV-1 inhibits the infection of CD4 T-cells by HIV.
Use resulted in an increase in the patient's CD4/CD8 index. CD4 T-cell counts were raised to healthier levels, with a 68% increase in CD4+T-lymphocytes. HIV viral loads were reduced. Tests showed an 80.5% drop in viral loads.
Use resulted in a decrease in the absolute number and the relative percent of CD8 lymphocytes. Use replaces or complements current anti-retroviral therapies. ITV-1 was less toxic than anti-retroviral and would be less costly.
ITV-1 was unaffected by HIV mutations that can hamper anti-retroviral therapies. ITV-1 demonstrated a good effect on opportunistic infections. ITV-1 had good compatibility with other anti-retroviral drugs. There was good tolerance without any side effects. ITV-1 use boosted the immune system to fight HIV infections. Acquired Immunodeficiency Syndrome is considered to be one of the most serious and chronic diseases, caused by the human immunodeficiency virus. The prevalence of HIV is souring at a significant rate. According to the World Health Organization an estimated 34 million individuals are currently living with the HIV virus. Due to increased awareness among people, there is now an increase in testing which has led to a surge in demand for HIV medications. There is no cure for HIV. The virus and its disease are treated by administering antiretroviral drugs that do not cure and must be taken for life. The global HIV drug market size was $28.79 Billion in 2020. Even though sales rise was moderated during the height of the COVID pandemic, a steady growth of 5.7% in 2020 occurred. The market is expected to grow from $30.46 Billion in 2021 to $45.58 Billion in 2028. The rise in CAGR is attributable to this market's demand and growth, returning to pre-pandemic levels once the pandemic subsides. To address this need, the Company is focused on both the production of its ITV-1 therapeutic and producing multiple anti-HIV monoclonal antibodies using its proprietary methodology. The Company's primary anti-HIV monoclonal antibody has been produced and successfully tested in vitro against multiple strains of the virus where it demonstrated complete efficacy. The recombinant form of the parent antibody has been successfully produced for the Company by Samsung Biologics. This recombinant antibody is currently undergoing efficacy testing in Europe and has shown significant activity even against drug-resistant HIV strains. Studies have confirmed the dual tropic activity of the HIV monoclonal Antibody-Clone 3. For HIV to be infectious, there is a requirement of specific binding between the virus envelope protein and the human CD4 cell at two receptor sites on the CD4 cell and the chemokine co-receptors CXCR4 and/or CCR5. The Company's Clone 3 Antibody interrupts the binding of the virus transmembrane gp41 to the human CD4 cells via blocking of binding to the 2nd co-receptor-to both the CCR5 and the CXCR4 receptors-on the CD4 cell surface. Because Clone 3 is dual-tropic, it consequently prevents HIV infection by abrogating the essential infectivity process which requires the fusion between the viral membrane and the CD4 cell membrane. The success of an anti-HIV monoclonal antibody would be significant.