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Approximately 10 million people across Europe and North America currently suffer from Graves’ disease – a little-known illness that is the most common cause of the immune system disorder, hyperthyroidism. Patients are currently presented with limited medical options to treat the disease and its symptoms, which range from mood swings and hand tremors to eye bulging and intolerance to heat.
Treatment options for Graves’ disease have not changed since the 1940s. Today, patients must choose between three therapies that tackle the symptoms, rather than the cause of the disease, all of which have significant side effects. First, they are treated with drugs that have a high failure rate. If medication is unsuccessful, they are offered surgery to remove the thyroid gland or radioiodine therapy to shrink or kill the thyroid gland – two treatments that can leave patients dependent on medication for the rest of their lives.
However, the EU-funded DAVIAD project is now offering hope for a safer, more effective treatment. Scientists working on the project have been able to harness recent advancements in immunotherapy to proceed with developing a new drug that could change the lives of millions of people.
‘Patients and clinicians are very excited that a new drug might be available in the future,’ says Kevin Barrell, programme manager at biotech company Apitope in the UK. ‘Right now, treatment options are limited and those that are available are not well tolerated.’
Safer and more effective
Graves’ disease and its associated hyperthyroidism are caused when a person’s immune system attacks their thyroid erroneously. While experts have yet to fully understand why this happens, the attack prompts the thyroid gland to produce more hormones than the body needs – causing the symptoms of the disease.
The DAVIAD project team set out to develop a drug that switches off only the sections of the immune system that are causing the disease, leaving the rest still functioning. This strategy is designed to minimise those side effects that are common among current treatment options.
Over the duration of the project, the team designed, tested and manufactured this new medication leading to the completion of the first clinical trial in 2018, with encouraging results. As scientists monitored the 12 trial participants who had taken the drug, they observed how the majority of the group responded positively, seeing a reduction in the thyroid hormones and antibodies responsible for the disease.
Promising results
‘This was a step forward in our mission to create a drug that treats the underlying cause of Graves’ disease instead of just the symptoms,’ says project coordinator Hayley French of Apitope. ‘In our promising early-phase results, we have shown both encouraging safety and efficacy.’
In the absence of any safety issues, the project team is now planning the next steps towards developing the drug. ‘Now DAVIAD is over, members of the project team are using the results of their first clinical trial to prepare for a second larger study,’ adds Barrell.
For people suffering from Graves’, the project’s progress has finally created hope that the disease can be challenged and, for the first time in over 70 years, a new, more effective treatment could be on the horizon.