Products & Pipeline
Diamyd Medical's pipeline is based on the patent-protected GAD technology for the treatment and prevention of autoimmune diabetes. GAD is the active substance in the diabetes vaccine Diamyd®.
Combination therapies key to curing type 1 diabetes
Diamyd Medical has independently pursued the development of the diabetes vaccine Diamyd® to global Phase III trials, leading to one of Sweden’s largest biotech agreements ever. The results from the first Phase III trial were not sufficiently strong, which is not unusual in drug development, but a small positive effect was observed and this will now be strengthened.
The dominating hypothesis among diabetes researchers today is that the key to curing type 1 diabetes is to simultaneously tackle the disease on several fronts by combining various therapeutics or by providing treatment before onset of the disease. Combination therapies have, for example, played a decisive role in the advances made in cancer treatment in recent years. Many leading scientists also believe that future treatment of type 1 diabetes must involve a so called autoantigen, such as GAD, which is the active substance in the diabetes vaccine, Diamyd®. Diamyd’s vaccine has the advantage of being ready for clinical studies in children due to its favorable safety profile in earlier clinical trials and an established manufacturing process.
The initial focus is to test Diamyd® both in combination with other drugs to boost the beta cell preserving effect displayed by the diabetes vaccine, but also as a preventative treatment to try to stop the onset of type 1 diabetes and other autoimmune diabetes altogether.
Researcher initiated trials
The continued development of the Diamyd® diabetes vaccine is primarily taking place via researcher-initiated, externally funded studies in which Diamyd provides the vaccine.
Two researcher initiated clinical studies with Diamyd® are in progress: A Swedish Phase II study, DiAPREV-IT, aiming to evaluate whether Diamyd® can prevent or delay type 1 diabetes in children who are at high risk of developing the disease and; a Swedish Phase II study, DIABGAD-1, where Diamyd® is tested in a unique combination with relatively high doses of vitamin D and the anti-inflammatory drug ibuprofen in newly diagnosed type 1 diabetes children and adolescents, aiming to potentiate the effect of the Diamyd® diabetes vaccine to preserve the body´s own ability to control the blood sugar level.
Diamyd has also recently secured a new exclusive license for a patent application for the specific combination therapy GAD plus the endogenous substance GABA, which has demonstrated favorable results in preclinical trials. The license also encompasses rights for the therapeutic use of GABA to treat diabetes and other inflammation-related disorders. Aside from being an important neurotransmitter in the central nervous system, GABA is believed to have an anti-inflammatory effect and the ability to boost insulin sensitivity. GABA and GABA receptor agonists can thus potentially be used to treat several inflammation-related disorders, such as type 1 and type 2 diabetes, metabolic syndrome and rheumatoid arthritis.