The European Patent Office has informed Diamyd Medical that the company’s patent application regarding prevention and treatment of autoimmune diabetes in individuals carrying the HLA DR3-DQ2 gene will be granted.
The patent is valid until 2035 and provides central protection in Europe for the treatment or prevention of genetically defined autoimumune diabetes using GAD, which is the active component in the therapeutic diabetes vaccine Diamyd. The patent claims cover the patient population in which Diamyd has shown efficacy and is targeted in the upcoming Phase III trial DIAGNODE-3.
A significant milestone
“The granted patent is a significant milestone for Diamyd Medical and our focus on precision medicine for autoimmune diabetes,” says Ulf Hannelius, CEO of Diamyd Medical. “The time is ripe for safe and targeted therapeutic diabetes vaccines, therapies that may revolutionize our possibilities to eliminate this devastating disease.”
HLA DR3-DQ2 has been shown to be associated with autoimmunity against GAD and represents one of the most common genetic risk factors for type 1 diabetes since about 40% of individuals with type 1 diabetes carry the gene. A large-scale meta-analysis published in Diabetologia in 2020 showed that positivity for HLA DR3-DQ2 is associated with clinical response to the diabetes vaccine Diamyd. This was prospectively confirmed in the Phase IIb trial DIAGNODE-2 that was published in Diabetes Care in May 2021.
A biological drug
In addition to the precision medicine patent that will be granted in Europe, Diamyd Medical already holds, as part of an exclusive license from the University of California, Los Angeles (UCLA), patent protection in the United States, which is valid until 2032 for the treatment of diabetes with GAD, a major autoantigen in autoimmune diabetes. Diamyd Medical also holds patent protection valid until 2035 in Europe, Japan, Russia, Israel and Australia for intralymphatic administration of Diamyd, the administration route used in the DIAGNODE-1 and -2 clinical trials and to be used in the upcoming Phase-3 trial with Diamyd.
As a biological drug, Diamyd will, independently of patent protection, enjoy twelve and ten years market exclusivity from the date of market approval in the US and Europe respectively, the company states.