Diamyd Medical

Diamyd Medical is a Swedish diabetes company active in the field of pharmaceutical development. Diamyd Medical’s shares are traded on Nasdaq Stockholm First North, ticker DMYD B.

Diamyd Medical develops the diabetes vaccine Diamyd®, an Antigen Based Therapy (ABT) based on the exclusively in-licensed GAD molecule, one of the major autoantigens in autoimmune diabetes. Diamyd Medical has also in-licensed technologies for GABA and Gliadin and investments in stem cell and medical technology.

Product portfolio

Diamyd Medical develops combination therapies for the treatment of autoimmune diabetes with the objective of preventing, delaying or stopping the autoimmune attack on beta cells by inducing tolerance to GAD, one of the major autoantigens in autoimmune diabetes and thus preserve the body’s own ability to produce insulin. The clinical research includes development of combination regimens including the GAD-based antigen-specific immunotherapy Diamyd^® and other compounds such as anti-inflammatory and immunosuppressing substances, including GABA, both in terms of preventing and intervening in type 1 diabetes.

By combining various substances with different mechanisms of actions, e.g. decreasing inflammation, suppressing the immune system, strengthening the beta cells and inducing tolerance, the disease is tackled on several fronts

Clinical trials

Six investigator-initiated clinical trials with Diamyd^® in different treatment regimens, including GABA, are ongoing. Four combination studies aim to intervene in the autoimmune type 1 diabetes process and two interception studies aim to prevent type 1 diabetes diagnosis in children at very high risk of developing the disease.

The diabetes vaccine Diamyd® has been evaluated in a global Phase III program in Europe and the USA, including more than 660 recent-onset type 1 diabetes children. The program was conducted in collaboration with the US pharmaceutical giant Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI). Results from the European study showed clinical effect in several subgroups and a limited overall 16 percent efficacy (p=0.10) in beta cell preservation .

Simultaneously, the research consortium Type 1 Diabetes TrialNet conducted a Phase II study in children and adults . The studies did not reach their primary efficacy parameters of preserving beta cell function and the Company decided not to complete the Phase III program, but have continued the clinical development of Diamyd® based on positive findings from the results. The Phase III program was based on positive results from a Phase II study in children with type 1 diabetes . Additionally, a placebo-controlled Phase II study in adult LADA patients has been conducted comparing the efficacy of different Diamyd® doses.

The ongoing investigator-initiated clinical trials and previous findings from Phase II and Phase III studies in children and young adults are leading the company to a better understanding of how to prevent, treat or cure type 1 diabetes.

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This article is issued from Wikipedia - version of the 5/26/2016. The text is available under the Creative Commons Attribution/Share Alike but additional terms may apply for the media files.