A New Solution For Dyslexia
Introduction
Dyslexia is a reading and spelling disorder and it is characterised by difficulty in learning how to read and spell and reduced reading speed (sometimes sufferers need two or three times more time than other people to read a specific script), which leads to having difficulty understanding what they are reading. Dyslexia sufferers often replace letters in a word with other ones which leads to mistakes being made and especially in stressful situations the percentage of mistakes increases. At some situations, only 10% of the words are spelled correctly and some are even avoided. Between 5% and 10% of children and adults suffer from the disorder and 40% to 60% of children with dyslexia suffer from additional psychological problems such as anxiety (1,2).
Nowadays, the treatment of dyslexia is mainly based on specific assistance of the patients within the areas of learning that they struggle with and at the same time psychological help to those who need it. Additional advice to parents and teachers are usually given and medical treatment is only available for dyslexia sufferers who also have Attention Deficit Hyperactivity Disorder (ADHD) (1,3). Almost 9% of children with dyslexia are leaving primary school in Netherlands (4). Widespread is the prejudice that dyslexia sufferers are unintelligent and not capable of doing things that other people can. The rate of dyslectic adults attempting suicide or having anxiety disorders is three time higher than people without dyslexia that have the same age and it is two times more likely for an adult to have depression if he is dyslectic. Owing to these facts, we can tell than the need for a solution, to help this group of people and make their lives a lot easier, is essential (1).
Where is our science based? Damage to the left hemisphere of the brain is usually connected with speech and language disabilities (5). Many studies that were conducted to find the cause of dyslexia, have found abnormalities in that area of the brain or found significant changes in the area before and after stimulation of the brain (2,6,7,8). We have to consider though, that during reading, the brain engages with letter forms, which is an activity the right hemisphere is responsible for, and there are studies that prove that dyslexia has to do with the right hemisphere as well (2,5,6,9,10,11). It is proven that the left hemisphere is more involved in everyday reading while the right one more when there are unknown words.
To a child, every word is uncommon at first, so we can assume that initial reading is more controlled by the right hemisphere (5), but after a point, reading starts to depend more on the left one. This is called hemispheric shift and there are two types of dyslectics based on this. Making the shift too early, results in L-type dyslexia which is characterised by high reading speed and various mistakes while inability to make the switch, results to P-type dyslexia characterised by low reading speed and fragmentation errors. Stimulation of the correct hemisphere of the brain for each type is an idea that looks like it has great potential as a temporary at least solution for dyslectics who are trying to deal with stressful brain activities (12).
Regarding some medications that are used nowadays, first of all it is believed that antimotion-sickness and related medications, such as cyclizine, meclizine and dimenhydrinate can significantly improve the memory and anxiety episodes that characterise dyslexia (13,14,15,16). Piracetam also, is a popular study drug, derivative of GABA, which has shown positive effects on dyslexia symptoms. Combination of the above drugs has proven to be more effective as a treatment for people with learning disabilities or dyslexia and attention deficit disorder (16,17,18,19).
Our solution
Our aim and main idea is to find the compounds to stimulate the correct hemisphere of the brain either the right or the left one, temporarily. If we combine these substances with anti-sickness drugs and drugs like piracetam or even anti anxiety drugs we can create tablets with which when dyslectics have to deal for example with a very important assignment or exams, they can take a tablet and their performance will be greatly enhanced. This will make dyslexia sufferers’s lives a lot easier. The final aim of this project is to create four different marketed drugs, to offer a range of products aimed at relieving different types of dyslexia. The first product, named Dysleximol L, will be addressed to L-type dyslectics and will be a combination of stimulants of the right hemisphere, anti sickness and study drugs. Dysleximol L-A will be a combination of the above but it will include anti anxiety compounds as well for the relieve of those symptoms to the dyslexia sufferers with additional phychological problems.
Similarly, Dysleximol P and Dysleximol P-A will be the 2 marketed products for P-type dyslectics and P-type dyslectics with additional psychological problems respectively. The MarketThere is a number of companies trying to undertake clinical trials to take advantage of the dyslexia treatment market and also various studies are conducted to understand the exact brain changes in dyslectics. North America is the dominant region regarding the dyslexia treatment market and Europe is the second largest. For example, Verdane Capital acquired the company Lingit, which provides support software for dyslexia sufferers. The key dyslexia market participants are DK Pharmachem, Pfizer Inc. , The Himmel Group, PRG Life Sciences Ltd, Purdue Pharma, Apotex Corporation, Cian Healthcare Pvt Ltd, Wallace Pharmaceutical Ltd. , Rhodes Pharmaceuticals and Unither Pharmaceuticals. In the UK, the dyslexia cost is $6,746 to $58,015. 60 per individual to the age of 37 and this brings to a total of up to $3. 37 billion (20). In the market though, there is nothing like the drug we want to produce which will be an easy and cheap solution for everyone with dyslexia to stressful situations. The packet will cost around 15 pounds, and each packet will contain four tablets.
As a first mover, even though there is a risk of predecessors to learn from our mistakes and successes, we are planning to earn strong brand recognition and give a great impression to the customers, because the improvement of their lives will always be our ultimate target.
First of all, the research that needs to be done to identify the stimulants of the left and right hemisphere, will be carried out in the university of Glasgow and with the collaboration of the Research & Development department of the university we will try to create a spin off company after the identification of the substances and apply for a patent. We hope that for the research part as well as the costs that need to be covered to set up this new company, we will be backed by investors as well, such as the Scottish investment bank and some angel investors. We will be seeking an initial funding of around 1 million pounds. Once the stimulants are found, the safety will be tested in animal models and the preclinical development will be carried out. In order to proceed and go through the preclinical trails though, a second round funding is essential and it has to be at least 10 million pounds and we are planning on targeting investors from all over the world and offer them equity stakes.
Furthermore, the clinical trails and the marketing of the drug require collaboration with pharmaceutical companies, such as Novartis and GSK for a third round funding which will be the largest and it could reach up to one billion pounds. This will enable us to move our drug into the clinical trails phase and market it in the best possible way, because pharmaceutical companies have long and successful experience in the matter. Our investors will be investing in a start up company with great expansion opportunities, a company that will be addressing a big gap in the market and they will earn exclusive shareholder perks.
In terms of time, the discovery of the stimulants is estimated to be around 2 years, while the duration of the preclinical development and the clinical trails around 3 and 5 years respectively. After a total of 10 years, we are planning of marketing the drugs in the UK and the European Union at first, and in our future plans US market is the next market target for our drug. Finally, because our primary aim is to make the lives of dyslexia sufferers better, the postmarketing surveillance is a really important part for our company, and we are planning of collaborating with health care professionals (for example the NHS) to make sure our product is safe and effective. In order to be able to move our product to clinical trails, and then launch it into the market we need to take the permission and meet the criteria of the regulatory agencies in other words we need regulatory approval in every stage. In the UK, the regulatory agency is the Medicines and Healthcare products Regulatory Agency (MHRA). Once our product is approved, it is allowed to be sold in the European Economic Area.
In the US, similarly, our product has to be approved by the FDA in order to be able to sell it. In terms of revenue, apart from the investments, we expect to make profit from our final marketed product but also from floating into the stock market (21,22).
Limitations and solutions
The first limitation is the possible side effects in younger children, because part of their brain are still forming but it will be prescribed only after careful consideration and only for specific situations. Another limitation, that most spin off companies face, is the extremely high cost, the considerable amount of research that needs to be conducted and the risk of not being approved by the regulatory agencies, but the possibility of the positive outcome and the improvement of peoples lives will drive the team forward. A final limitation lies within the trust of the customers for the product at the first stages of marketing, but we believe that with the right techniques it will be widespread and the benefits from it will make it really popular and profitable.
The Future
It can be seen from the roadmap, that the plans of the company and the product are not limited in the UK but as it will benefit the dyslexia sufferers all over the world, that is our market target as well. Another target of our company is to try constantly to improve the drug, which means continue the research on it, reduce the side effects and maybe organise some charities and offer it to people who do not have the money to purchase it. Our final aim, is to expand the company, try to make as much as we can in house and form more and successful partnerships.
