Diamyd, an antigen-based drug to treat and prevent type 1 diabetes is currently in final phase of patient testing.
Diamyd is therapy based on the GAD65 gene. This antigen drug is designed to prevent, delay, or stop the autoimmune attack on beta cells in type 1 diabetes and other forms of autoimmune diabetes, thereby preserving the body’s capacity to regulate blood sugar.
This reduces the risk for both acute and long term diabetes complications significantly.
Beta cells in the pancreas is responsible for the production of insulin hormone that controls glucose level in the body.
A study of 70 children and adolescents with type 1 diabetes published in The New England Journal of Medicine in 2008 showed that Diamyd significantly slowed the progression of the disease in subjects with newly-diagnosed type 1 diabetes.
Phase II data also show reduction of insulin dependence after five years in treated patients with Latent Autoimmune Diabetes in Adults (LADA) – a less aggressive form of autoimmune diabetes that affects adults.
Diamyd is a convenient treatment and has not been associated with any serious side effects.
Diamyd is currently being evaluated in two parallel phase III studies in Europe and USA.
The European study is fully enrolled and results are expected in the spring of 2011.
The US study, DiaPrevent, is enrolling patients recently diagnosed with type 1 diabetes, according to Diamyd Medical AB, which has developed the antigen therapy
Several externally funded and researcher-initiated studies of the Diamyd diabetes antigen based therapy are also in progress, including a Phase II study aiming to prevent type 1 diabetes from developing in high risk subjects.
Diamyd Medical AB has recently signed an agreement with Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI), a Johnson & Johnson company, to develop and commercialize the Diamyd diabetes therapy.
Ortho-McNeil-Janssen Pharmaceuticals will commercialize GAD65 antigen-based therapy Diamyd for the treatment and prevention of type 1 diabetes and associated conditions.
OMJPI will make an upfront payment of USD 45 million, and under the terms of the agreement, Diamyd has the potential to receive additional development and sales milestone payments of up to USD 580 million, as well as tiered royalties on future sales.
Meanwhile, Diamyd has secured exclusive rights for commercialization in the Nordic countries.
Diamyd also retains the rights to the therapeutic use of the GAD65 gene and derivatives, fragments and variants of the GAD65 protein.
Diamyd Medical is a Swedish public company focusing on the development of pharmaceuticals for the treatment of autoimmune diabetes and its complications.
The company has clinical-phase products from two proprietary technological platforms in its pipeline; the diabetes antigen based therapy, Diamyd in phase III and NP2 for chronic pain in phase I.
The company has out-licensed the use of the GAD65 gene for treatment of Parkinson’s Disease to Neurologix Inc., New Jersey, United States