This content material initially appeared on diaTribe. Republished with permission.
By Andrew Briskin
In the search for new and revolutionary methods to deal with kind 1 diabetes, researchers have regarded to develop therapies that defend or enhance the physique’s capacity to provide its personal insulin. Learn concerning the fundamentals of a vaccine at the moment in improvement and the way it may doubtlessly sluggish or halt the development of kind 1 diabetes.
For many years, kind 1 diabetes remedy has targeted on treating the situation, primarily with insulin. In current years, nevertheless, therapies that concentrate on the immune system (immunotherapies) have gained increasingly more traction of their potential to delay or forestall kind 1.
You could have heard about a new drug known as teplizumab, which has gained a lot pleasure attributable to its potential to focus on the immune system and delay a prognosis of kind 1 diabetes for two years or extra. A vaccine referred to as Diamyd, whereas not as far alongside in improvement as teplizumab, additionally holds promise as a potential immunotherapy for kind 1.
As a reminder, kind 1 diabetes is a situation the place the physique’s personal immune system assaults and destroys the cells within the pancreas that produce insulin, referred to as beta cells. This happens due to one thing known as an auto-antibody. Antibodies are a part of your immune system, and their function is to determine and neutralize micro organism and viruses. Auto-antibodies, nevertheless, mistakenly goal a number of of your physique’s personal proteins, which can injury tissues and organs. One auto-antibody sometimes present in individuals with kind 1 diabetes targets a kind of protein referred to as GAD-65.
The destruction of the beta cells progresses at totally different speeds, relying on every particular person. However, by the point kind 1 diabetes is often identified, roughly 80% of beta cells have been destroyed. This injury continues till the individual turns into utterly depending on insulin injections.
But what if a vaccine may cease this auto-immune destruction earlier than it even happens? Enter Diamyd Medical, a Swedish biotechnology firm taking a distinctive method in growing a kind 1 vaccine, Diamyd.
Because GAD-65 is discovered within the beta cells of the pancreas, auto-antibodies towards GAD-65 acknowledge the protein and injury the beta cells. “What we want to do is re-program the immune system, specifically how it reacts to GAD-65. It’s like a reverse, or therapeutic, vaccine,” mentioned Ulf Hannelius, CEO of Diamyd Medical. “The objective is to change the pro-inflammatory, autoimmune reaction to GAD-65, and to skew that to an anti-inflammatory reaction.”
How it really works
Researchers at Diamyd are at the moment taking the method of injecting a small quantity of the GAD-65 protein into a lymph node a number of instances through the examine. (Lymph nodes are small, bean-shaped constructions all through the physique that comprise among the physique’s immune cells.)
The hope is that these immune cells will journey to the pancreas, encounter a beta cell with GAD-65, and as a substitute of destroying the beta cells, work to scale back the assault and protect them.
Where we’re at the moment
Over the previous 20 years, a number of obstacles have emerged, together with a trial that failed to demonstrate the vaccine’s effectiveness that was suspended in 2011. Since that point, nevertheless, the corporate has made a number of modifications. According to Hannelius, the corporate has modified the way in which that the vaccine is run (immediately into the lymph nodes as a substitute of below the pores and skin), and is now recruiting members from a barely broader age vary (12-29 years) than earlier than.
“We haven’t made any actual change to the drug or formulation, but we now administer the vaccine directly to the lymph nodes, the site where the immune reaction happens, with a much smaller dose,” mentioned Hannelius. “Even with the smaller dose, we are now seeing a much stronger immune response compared to when we injected [just under the skin].”
Additionally, the corporate now screens for the presence of a specific gene associated with a high risk for type 1 diabetes. According to Hannelius, this gene is present in as much as 40% of individuals with kind 1, with this sub-group displaying a notably positive response in scientific trials.
In the previous two years, knowledge has been promising. In 2021, the corporate revealed outcomes from its part 2b trial, DIAGNODE-2. This examine, which included 109 examine members ages 12-24, confirmed that the vaccine improved glucose administration, as measured by Time in Range, in not too long ago identified examine members all through the 15-months of the examine, in comparison with the placebo group.
Diamyd and LADA
On July 7, Diamyd introduced outcomes from a 14-person security examine with promising leads to individuals identified with latent autoimmune diabetes in adults (or LADA). LADA, like kind 1, is a type of autoimmune diabetes, however the assault on beta cells takes longer, with the prognosis often occurring in adults. The full examine outcomes will probably be offered on the European Association for the Study of Diabetes (EASD) 2022 annual convention in Stockholm, Sweden in September, which diaTribe will probably be attending on-site.
Upcoming Diamyd Clinical Trial
Diamyd is now beginning a new part III trial known as DIAGNODE-3. On May 19, Diamyd announced that the trial enrolled its first participant. The trial is at the moment enrolling at 20 clinics throughout a number of European nations together with Sweden, Spain, Germany, the Netherlands, Poland, and Czechia. Researchers hope to incorporate 330 members in whole.
While the trial has been on a partial clinical hold within the U.S. since October 2021, Hannelius talked about that the corporate is working exhausting to deal with the FDA’s considerations. He hopes that the FDA will have the ability to raise the scientific maintain in time for Diamyd to supply the trial to US clinics and sufferers.
In normal, Diamyd represents one other effort to seek out an immunotherapy that would doubtlessly delay or forestall kind 1 diabetes, and forestall problems sooner or later. Researchers proceed to work in the direction of new and revolutionary methods to deal with kind 1 diabetes, and the Diamyd vaccine may ultimately develop into a remedy choice that, in contrast to insulin, combats the immune response that results in kind 1 diabetes.
To discover out extra concerning the DIAGNODE-3 trial, taking part European areas, and eligibility, learn the clinical trial page or contact [email protected] for extra data.
To discover out extra about immunotherapies for kind 1 diabetes, learn these articles:
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