FLIP7

• Antibiotics are unlike many other drugs used in medicine, as the more we use them the less effective they become against their target organisms.
• The Antibacterial Resistance (ABR) is the World’s number 1 health problem according to the World Health Organization. Globally, 700,000 people died in 2018 as a result of infections caused by bacteria resistant to antibiotics.
• Antibacterial Resistance has devastating effect on health, human life and economy. It is the biggest treat to humanity, even bigger than terrorism or global warming.
• A failure to address the problem of antibiotic resistance will result in an estimated 10 million deaths every year globally by 2050 and a cost of 85 trillion USD in loss productivity to the global economy.

• FLIP7 is a natural peptide complex comprising of four (4) groups of antibiotic peptides: defensins, cecropins, diptericin’s and proline-reach peptides. It also includes anti-viral and anti-fungal components.
• Studies demonstrate the advantages of the natural antimicrobial complex FLIP7 in comparison with traditional antibiotic therapy. FLIP7 is effective against many (although not all) strains with acquired and natural antibiotic resistance, including highly resistant bacterial biofilms. The peptide complex is protected from the development of resistance in gram-negative bacteria, it can inhibit the growth of resistance to conventional antibiotics when combined and is not toxic to human blood cells, which makes it promising for use in medicine and cosmetology.
• The FLIP7 AMP complex-based medical drugs can be used alone, or in a combined therapy of bacterial infections as antibiotic synergists, or for the suppression of the bacterial biofilm.

1. FLIP7 topical (clinical trial finished)
A topical solution (medical device class 2b) has been developed for treatment of skin infections, diabetic foot ulcer, wounds, burns, pyoderma and post-surgery infections.

2. FLIP7 inhalation device (under development)
A drug is under development for treatment of respiratory infection diseases such as pneumonia, tuberculosis (including drug-resistant tuberculosis), bronchitis and other respiratory infections.

3. Antibiotic adherent (under development)
Not only that FLIP7 is able to enhance existing antibiotics to successfully combat antibiotic resistant bacteria, but this feature of FLIP7 will allow manufacturers to produce antibiotics that are much smaller in size and without side effects. This function can be achieved by creating a simple FLIP7 product that will be administered together with all types of antibiotics.

ONE SOLUTION to solve 80% of the entire Antibacterial Resistance problem globally.

The efficacy of the first FLIP7 product – Entomix was proven in a clinical trial in Russia, that was conducted in 3 leading hospitals. The clinical trial was conducted under a medical device class 2b classification; the result is GOLD standard in all tests.

Link to the website of the medical registry:
(http://reestrinform.ru/reestr-clinicheskikh-issledovaniy/id-5405.html).

Name of medical device:
Hydrogel coating to suppress the development of bacterial biofilms according to TU 21.20.23-006-72500079-2017

End of Clinical Trial: End of December 2019

Results:
The official results of the clinical trial are described in the slides below.

The results of the clinical trial positioned ENTOMIX as a GOLD STANDARD in treatments of (1) pyoderma, (2) diabetic foot ulcer, (3) burns, (4) post-surgery wound infections and (5) Antibiotic resistant bacterial infections.

Product Registration:
The product registration of Entomix in Russia completed successfully in December 2020, and we already received market authorization from the Russian ministry of health.

• Pneumonia and other lower respiratory tract infections are the leading cause of death worldwide. In 2016, there were approximately 150 million new cases of pneumonia among children younger than 5 years worldwide, accounting for approximately 10-20 million hospitalizations, and 880,000 deaths.
• Pneumonia is the world’s leading killer of children below 5, killing approximately 2,400 children a day or 876,000 children in 2016. Latest forecast show that the global morbidity will rise to 11 million children below the age of 5 by 2030.
• In 2015, more than half of the world’s annual new pneumonia cases are concentrated in just five countries where 44% of the world’s children aged less than 5 years live: India (43 million), China (21 million) and Pakistan (10 million).
• In China, pneumonia is the 4th leading cause of death in urban areas, and number 1 cause of death in rural areas. 125,000 (5%) of those patients die each year.
• The global pneumonia therapeutics market is expected to reach USD 26.37 billion by 2026, at a CAGR of 8.39% from 2019. In 2018, the global vaccines segment was 7.42 billion and the pharmacy segment was 6 billion USD.
• Antibiotics can be effective for many of the bacteria that cause pneumonia, but Antibiotic resistance is growing amongst the bacteria that cause pneumonia. There are no treatments for viral causes of pneumonia (Allostatine has potential to be efficient in this space).
• The FLIP7 inhalation device will not only be able to treat pneumonia more efficiently than the current antibiotics, but will also treat deadly pneumonia cases (caused by bacteria that is resistant to antibiotics).

• Worldwide
  One third of the world’s population is currently infected with the tuberculosis (“TB”) bacillus, but only 5%-10% of people infected will become sick with the disease in their lifetime.
• Worldwide, TB is one of the top 10 causes of death. In 2018, an estimated 10 million people fell ill with TB worldwide, and a total of 1.5 million people died from TB.
• Multi-drug Resistant Tuberculosis MDR-TB is a particularly dangerous form of drug-resistant TB (resistance to at least isoniazid and rifampicin). MDR-TB is treatable, but requires extensive chemotherapy (up to two years of treatment) with second-line anti-TB drugs. Second-line drugs are more costly than first-line drugs, and can cause adverse reactions that are more severe, though manageable.

China

• The level of TB in China makes it a major public health problem. China has the world’s second largest TB epidemic after India, with a quarter of the word’s TB burden. In 2014 there were an estimated 930,000 new cases of TB in China, and an estimated 120,000 cases of pulmonary MDR-TB. Overall China has 10% of the global burden of TB with 400 million people having latent TB.
• In 2019, China had the world’s second largest burden of MDR TB, with 63,000 new cases or 1/3 of the world’s MDR-TB cases.
  Despite huge efforts by the government, the MDR-TB treatment in China remains out of reach for many, in particular in the rural areas. The cost of an MDR-TB in China is above 300,000 RMB per treatment.
• Only 55% of the MDR-TB treatments are successful – the other patients died.

FLIP7 improves efficacy of many vitally important antibiotics

Not only that FLIP7 is able to enhance existing antibiotics to successfully combat antibiotic resistant bacteria, but this feature of FLIP7 will allow manufacturers to produce antibiotics that are much smaller in size and without side effects. This function can be achieved by creating a simple FLIP7 product that will be administered together with all types of antibiotics. ONE SOLUTION to solve 80% of all Antibacterial Resistance problems globally.