Lyme disease has been perplexing scientists by spreading virulently across America and Europe in recent months. However, a new drug has been developed by the company Valneva, which it is hoped will combat the spread. Valneva has just been given permission from the Food and Drug Administration (FDA) to start testing its new drug on people from the US and Europe, so it is hoped this will be a new weapon in the battle against Lyme disease.
What is Lyme Disease?
Lyme disease is caused by bacteria called Borrelia, which are spread by small ticks. Sufferers feel intense fatigue, joint pain, numbness and cognitive impairment. Left untreated, this can spread to heart problems or brain inflammation and can even prove fatal – http://www.nhs.uk/Conditions/Lyme-disease/Pages/Introduction.aspx.
Since 2002 there has been no vaccine against the disease and this is why it has grown into an epidemic, with around 300,000 new cases being diagnosed in the US and 85,000 in Europe every year.
In 1998, a vaccine against Lyme disease was developed called LYMErix, which cost $50 per dose. This vaccine was 80% effective but SmithKline Beecham (now GlaxoSmithKline) ceased the sale of their drug in 2002.
Since then, sufferers have been prescribed antibiotics to fight the disease. However, Valneva has now been given the go-ahead from the FDA and from the European Union’s Clinical Trial Application to test its brand new vaccination.
Phase 1 of testing
The drug will go into phase 1 of testing which means it is going to be tested for safety for use on humans. Taking the drug through 3 phases of testing will cost over $1 billion. However, with treatments for sufferers currently costing $1 billion per year, the development of a new drug would save a lot of money in the long run.
One problem of running long tests is making sure they are staffed effectively. Clinical staffing can be an issue where there are shortages. Thankfully, there are companies such as http://www.gandlscientific.com/clinical-staffing-solutions/ which can provide staffing for short or long-term projects and contracts, as well as permanent staff to ensure the effective running of any clinical trial.
Once Valneva has tested its new drug on humans, if proved safe, it will move on to phase 2 and 3 of testing to prove it is effective against Lyme disease.