After many years as Chairman – back as the CEO! Peter Zerhouni our former CEO did an excellent job for Diamyd Medical during his just over eight years at the Company, and we wish all the best in his continued career as he progresses in the industry. I have accepted the challenge of filling his shoes while we search for his replacement.
Diamyd Medical faces an exciting future where the focus is on developing a new drug for autoimmune diabetes. Autoimmune diabetes, which includes type 1 diabetes and LADA, is characterized by the body’s immune system attacking the insulin-producing beta cells, which means that insulin must be provided from an external source for the patient to survive. There is currently no approved treatment in the market that can interrupt or prevent the autoimmune process. By using the diabetes vaccine Diamyd®, we want to stop the immune system’s attack on the insulin-producing beta cells to preserve the body’s vital capacity to produce insulin.
Currently, some 380 million people worldwide suffer from diabetes. Ten to 15 percent of these, about 50 million people, are estimated as having autoimmune diabetes. Of these, we estimate that at least three million are in the US. The American Diabetes Association states that total costs for diabetes in the US are estimated at USD 245 billion for 2012. We estimate that at least USD 30 billion of this amount are attributable to autoimmune diabetes in the US.
Back to the future
What do we mean by “Back”?
Let us just remind ourselves of the results from Diamyd Medical’s European Phase III study that included 334 children and adolescents with type 1 diabetes. The diabetes vaccine Diamyd® showed a total efficacy of 16.4 percent (p=0.10) with regard to preserving the body’s capacity to produce insulin 15 months after treatment with Diamyd® compared to placebo.
The participants received either two or four doses of the diabetes vaccine Diamyd® or placebo. In the same year as most of the patients in the study were treated, there was an unforeseen mass vaccination against swine flu, which may have impacted the study results. It is also interesting that the group of patients that started treatment with Diamyd® in the spring produced more than 50 percent more insulin than those who received placebo during the same period. This could, for example, be due to seasonal variations in the immune system where, for example, infections, other vaccines and vitamin D levels in the blood have an impact. There were also other sub-groups, such as boys and participants in the study from countries outside the Nordic region, that posted statistically significant efficacy compared to placebo.
We now hope to be able to enhance the effect by combining the diabetes vaccine Diamyd® with other substances.
What do we mean by “the Future”?
The future is analyzing the five ongoing, soon six, studies with the diabetes vaccine Diamyd®. Next up is a presentation, focusing on immunological markers, of the six-month results from the DIABGAD study with Diamyd® in combination with vitamin D and ibuprofen. The immunological markers are important to follow since they can provide an early indication of how the treatment impacts the disease progression. The immunological results will be presented at the Immunology of Diabetes Society’s (IDS) International Congress being held from April 12 to 16 in Munich. The metabolic results, such as the treatment’s effect on the ability to produce insulin, are expected to be ready for presentation at the end of 2015, when all patients have completed their 15-month follow-up.
The future, means analyzing the five-year results at the end of 2016 of the first prevention study, DiAPREV-IT 1, with Diamyd® in 50 children with a very high risk of developing type 1 diabetes.
The future, means analyzing the results of the Diamyd®/GABA intervention and combination study in Alabama, USA, which is currently enrolling patients. This also applies for the new prevention study started this year, DiAPREV-IT 2, in Malmö, and DIAGNODE in Linköping where Diamyd® is administered directly into lymph nodes in five adults recently diagnosed with type 1 diabetes, in combination with treatment with vitamin D.
The future is also to initiate and analyze the open EDCR combination study with 20 children and adolescents who have recently been diagnosed with type 1 diabetes, where Diamyd® is combined with vitamin D and etanercept.
It is notable that Craig Beam, Professor of Epidemiology and Biostatistics at Western Michigan University Homer Stryker M.D. School of Medicine in Kalamazoo, USA, reanalyzed these three studies with the Diamyd® diabetes vaccine on his own initiative and used Bayesian statistical methods. The findings were that the probability that the diabetes vaccine Diamyd® is effective in preserving insulin production was 99 percent in Diamyd Medical’s previous Phase II study, 69 percent in TrialNet’s Phase II study and 97 percent in Diamyd Medical’s European Phase III study. The prominent diabetes research scientists that are co-authors to Beam’s analytical results include Jerry Palmer, Diane Wherrett, Kevin Herold, Johnny Ludvigsson, Colleen MacCallum and research scientists in the Type 1 Diabetes TrialNet Study Group.
Will we form a partnership? The future will tell. We are working on it. We received a little help recently from the granting of a new patent in the US that until 2032 protects our diabetes vaccine Diamyd®, which is considered the furthest developed Antigen Based Therapy (ABT) for autoimmune diabetes in the world.
Stockholm, April 1, 2015
President and CEO Diamyd Medical AB (publ)