Dramatically improve the global landscape of flu treatments with a product that excels all existing non-prescription and prescription solutions
Our goal is to improve self-treatment of flu and flu-like infections, especially in people with chronic diseases; put it in line with the latest scientific discoveries and make it more effective and safe
Contents of this page:
1. The landscape of self treatments for flu-like infections: almost nothing has changed over the last 50 years
We live in the age of high technologies that shape our everyday life. But when it comes to self-treatment of flu, today it is much the same as it used to be in the 1960-s:
(1) antipyretic / fever reducer (acetaminophen, or APAP), + (2) decongestant, and + (3) antihistaminic
You won’t believe that, but APAP was first synthetized in 1873, in the age of steam engines! Yet, it did not enter the US market until 1955, when Tylenol replaced the more toxic phenacetin. In 1956, acetaminophen went on sale in the United Kingdom under the trade name “Panadol” (see APAP history). Today APAP is #1 selling non-patented drug in the world; every day millions of people take it as a painkiller and fever reducer (reference). Thus, APAP has been around for 50+ years; and over the last 50 years almost nothing has changed in the self-treatment of flu-like infections.
The homeopathic best-seller for flu, Oscillococcinum, was invented in 1925. The ingredients of other homeopathic self-treatment products are even much older.
2. Today’s self-treatment for cold & flu is like using an electronic calculator instead of a laptop
Imagine that other technologies were developing at the same pace as self-treatment of flu. Then you would have: 1) no PCs 2) no mobile phones 3) no internet (let alone iPhones and many other gadgets). You would still have to use: 1) old fashioned electronic calculators 2) land line phones 3) paper mail.
3. Today’s medications for self-treatment of flu lack proof of efficacy
Today’s medicine claims itself The Evidence-Based Medicine. That means, the efficacy of every product used for a particular condition should be confirmed in properly designed placebo-controlled clinical trials. Surprisingly, the routine use of products for self-treatment of flu-like infections is rather based on established habits and experts’ recommendations than on sound evidence:
1) According to one of the most respected source, Cochrane Collaboration, there is no proof of APAP clinical benefit in flu done to today’s standards of Evidence-Based Medicine – i.e., large-scale placebo-controlled clinical trials (reference).
2) Even with common colds the benefit of APAP remains unproven: according to Cochrane database, “Acetaminophen may help relieve nasal obstruction and rhinorrhea but does not appear to improve some other cold symptoms (including sore throat, malaise, sneezing and cough)”.
3) In animals, treatment of influenza infection with antipyretics (fever reducers, including APAP) in therapeutic doses increases the risk of mortality (reference), increases viral shedding and prolongs the infectious period (reference).
The efficacy and even clinical utility of fever reducers (such as acetaminophen/paracetamol) in influenza has been further questioned in a recent clinical trial performed in New Zealand (reference)
In practice, most doctors rely on regulatory advice and proceed from the assumption that regulators base their guidelines on sound evidence. This is more or less true for new investigational products, but not for products registered decades ago.
4. Today’s 'mainstream' medications for self-treatment of flu are not safe, especially to people with chronic diseases
Another, probably even more important problem is safety.
Acetaminophen (APAP, paracetamol) is one of the most important drugs responsible for predictive drug-induced liver injury in the world. In the US alone, APAP overdose is responsible for 78,000 emergency room visits and about 500 deaths per year (reference).
Other ingredients present in the most popular products for cold and flu (decongestants and antihistamines) have other side effects (check here and here) and contraindications. Summary of these safety issues most important for the elderly can be found here.
As a result, about 1.5 billion adults in the world who have most common chronic diseases cannot use symptomatic medications for flu due to safety concerns.
The list of these diseases includes diabetes, high blood pressure, coronary (ischemic) heart disease, chronic pulmonary diseases like asthma, and others.
So today's medications for self-treatment of flu that date back to the 1950s are both marginally ineffective and unsafe.
5. Today's approaches to flu management with proven efficacy: what's wrong with them?
There are several reasons why elderly people cannot rely on flu vaccination as the single protection from flu:
- quite often the flu vaccine does not fit the circulating influenza virus;
- flu vaccination is considerably less effective (judjed by antibody titers) in the elderly than in younger people (reference);
- a major part (>50%) of flu-like infections during flu season are caused by viruses other than influenza;
- disease severity in influenza and flu-like infections is determined much more not by the virus itself but by the adequacy of host response: the right balance between protection and inflammation (reference).
That’s why even those elderly people who have had a flu shot need an effective and safe treatment for a breakthrough flu.
Healthcare authorities recommend antivirals for confirmed influenza cases.
Clinical trials of oseltamivir (Tamiflu) suggest that it reduces disease severity by about 35% and disease duration by about 24 hours. However, in real life antivirals proven effective for flu (like oseltamivir) have certain serious drawbacks:
1) they need doctor’s prescription (hence extra costs);
3) they cannot be taken together with some medications for a condition common in the elderly - diabetes (chlorpropamide – see PIL of Tamiflu);
4) an important problem of antivirals like oseltamivir is that influenza virus is becoming resistant to them (reference);
5) postmarketing reports of oseltamivir suggest that it may aggravate diabetes which is present in about 10-15% of elderly people (reference);
The review of Tamiflu efficacy based on ALL clinical trials of the product suggests that its actual benefit in reducing influenza duration is quite small, approximately half a day. Also, there is no evidence for patients, clinicians or policy-makers to use these drugs to prevent serious outcomes, both in annual influenza and pandemic influenza outbreaks (Details).
6. Today's technologies fall far behind the discoveries made by the medical science over the last decades
The most important discoveries were made in the late 1990s and awarded Nobel Prize in 2011. They revealed the fast and very powerful innate response that the body develops when it detects virus inside the cells. These discoveries have overturned our understanding of:
1) why and how the body develops similar symptoms in different viral infections;
2) what are the roles of the virus and the body reactions in the disease;
3) what are the most promising approaches to treat viral infections.
It is generally believed that in vaccinated people influenza infection is milder than in unvaccinated (provided than vaccine matches the circulating influenza virus type). This is thought to be due to lower viral load, i.e. lower amount of viruses entering the body.
Also, antivirals that block virus replication and dissemination in the body are also considered to reduce disease severity. For example, clinical trials of oseltamivir (Tamiflu) suggest that it reduces disease severity by about 35% and disease duration by about 24 hours.
However, the virus itself is not the only contributor to flu severity and duration.
Recent research suggests that the host (the body’s) response is a much more important factor determining flu severity. In particular, disease severity in influenza and flu-like infections is determined not by the virus itself but by the adequacy of host response: the right balance between protection and inflammation (reference).
Interestingly, according to recent findings, in many cases (up to 75%) influenza infection passes without any symptoms even in unvaccinated people (reference).
That is, our body plays a much more important role in the outcome of flu than we and most doctors used to think. In fact, it is our body, not the virus who determines whether the infection would pass unnoticed or would bring you into the hospital. That's why the body's response is now considered a much more promising target for therapeutic intervention than the pathogens.
However, these new concepts are not taught yet in medical schools, and most general practitioners are not aware of them. On the other hand, large pharma companies have not been able yet to take advantage of these discoveries and upgrade the technology of the 1950s to a level comparable of upgrading an old calculator to a personal computer, or a land-line phone to a mobile smartphone.
7. Our technology platform offers advantages that any pharmaceutical company might benefit from
The reasons why The Big Pharma cannot make a technological breakthrough despite their huge R&D budgets are very complex. In the first place, they are rooted in a lame mechanistic mindset (called ‘reductionism’) and a wrong model of how human body is regulated. Luckily, there is a more adequate model that forms the foundation for our drug development technology platform. Now we can turn the scientific breakthrough into a new technology.
The first result of applying our technology platform is Cont®aFlu. This is a high grade product that can be used as a self-treatment for flu-like infections in people with chronic diseases who cannot use common symptomatic drugs for flu. Cont®aFlu is based on highly specific antibodies to a molecule called TLR3. This is an important player in the body’s early response to many viruses including influenza. Cont®aFlu is developed in line with the standards of Evidence-Based Medicine. It accelerates recovery from influenza disease by >2 days, reduces disease severity by more than 30% and has no side effects. Owing to this efficacy-safety combination, Cont®aFlu stands out among all existing medications for influenza, flu-like infections and severe cases of common cold.
How Cont®aFlu was developed
ContraFlu project started in 2007.
One of Cont®aFlu authors, Andrey Martyushev-Poklad (AMP) had prior successful experience of developing six non-prescription products based on antibodies, including Anaferon, one of top selling OTC products for cold and flu in Russia. Anaferon reached $70+M of annual sales (reference). This prior experience resulted in a technology platform for drug development that can be termed as 'Antibody-based Modulation of Biological Response'. AMP decided to choose respiratory viral infections as its first practical application.
Together with his Belgian co-author, Michel Thiry (MT), AMP upgraded the ‘ancestor’ drug development and manufacturing technology used in Russia, and applied it to Nobel Prize winning science of innate immunity to viral infections.
Cont®aFlu contains an oral composition of highly purified rabbit antibodies against a specific regulatory fragment of human TLR3 (Toll-like receptor type 3). The science behind Cont®aFlu is quite complex. It is covered in part on the page 'How it works'.
Cont®aFlu along with several other candidates and Anaferon was screened in an animal model of influenza. In a double blinded study performed by a contract research organization in the USA, Cont®aFlu outperformed all other candidates and Anaferon, and was chosen for further development (see below the graph with animal study results).
After obtaining European patent and upgrade of manufacturing technology (antibody purification) to GMP level, Cont®aFlu was tested in a GCP-compliant randomized placebo controlled clinical trial performed in Belgium.
Here you can download an 12-page slide deck of Contraflu project
(a 2Mb file)
The IP package of Cont®aFlu is available for acquisition.