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The Diamyd story

Diamyd Medical is a diabetes company with a long history. In 1994 Diamyd Medical licenses the rights to GAD - the active substance in the Diamyd® antigen-based diabetes therapy. During the late 1990's, a large number of preclinical studies are conducted to ensure the substance's safety and efficacy. Studies in models of autoimmune diabetes indicate that the substance is safe and can stop or prevent the immune system from attacking the insulin-producing cells.

At the turn of the millennium, it is time to take the major step of testing the antigen-based therapy on human subjects. Within a few years, a Phase I safety study is conducted on healthy volunteers, and a Phase II study is conducted on patients with LADA (Latent Autoimmune Diabetes in Adults). This is done both to see whether the antigen-based therapy is safe and has the desired efficacy in humans, and to determine the optimal dosage. Both studies show positive and desirable results.

The following years Diamyd Medical conducts two additional Phase II studies, one on adult LADA patients and the other on children and adolescents with type 1 diabetes. Diamyd Medical successfully completes the Phase II study in type 1 diabetes, and can demonstrate that the antigen-based therapy has slowed the autoimmune attack in the children and adolescents who were part of the study. Based on these results, in 2008, the Company receives approval from the US FDA (Food and Drug Administration) and several European regulatory agencies to begin pivotal Phase III studies in type 1 diabetes. In June 2010 the Company signs an agreement with Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI), a Johnson & Johnson company, to develop and commercialize Diamyd® and receives an upfront payment of USD 45 million. In May 2011 the Company reports that its European Phase III study did not show a statistically significant preservation of beta cell function after 15 months of follow-up compared to placebo, although a small positive effect was seen. Furthermore, Diamyd® is well tolerated, as demonstrated by a similar number of adverse events in the Diamyd® treated groups as well as in the placebo treated group. In June 2011, OMJPI returns all rights to Diamyd® and the Company decides not to complete the follow-up period of the European Phase III study of Diamyd® as well as to initiate the closure of the parallel US Phase III study.

In the years 2010 to 2012, several competing firms have reported discouraging results from other Phase III studies using other compounds than GAD to try to preserve beta cell function in type 1 diabetes patients. This has led the diabetes scientific field to lean towards trying combinations of drugs to attack this complex disease from several angles to try to intervene in the autoimmune disease process underlying type 1 diabetes, or, to try to intervene earlier in the disease process in order to prevent type 1 diabetes in persons at high risk of developing the disease.

Lessons learned are guiding the future development of Diamyd® and GAD. Ways forward being explored include combining GAD with other drugs, administering GAD earlier in the disease process to prevent type 1 diabetes, and different treatment regimens or new formulations of GAD.

Accordingly, the development of the Diamyd® diabetes vaccine continues with several parallel researcher initiated Phase II studies. At this time, 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; another 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 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.

In April 2013 it was decided to spin out and capitalize the former subsidiary company Diamyd Therapeutics (now renamed Diamyd Medical AB) with SEK 50 million to continue the work to find a cure for autoimmune diabetes, focusing on continued development of the diabetes vaccine Diamyd® and GAD. The former parent company has been renamed Mertiva. The shares in the new Diamyd Medical AB are traded on Nasdaq Stockholm First North as of May 20, 2013.

In May 2013, the company secured a new exclusive license for a patent application for the specific combination therapy GAD and GABA, which has demonstrated favorable results in an animal model of type 1 diabetes. 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.