Quarterly Report 1, January 24, 2018

Dear Shareholders and Readers

The last two months were dominated by new and promising results from DIAGNODE-1, the ongoing investigator-initiated trial where the diabetes vaccine Diamyd® is administered to the lymph node in recently diagnosed patients suffering from Type 1 diabetes. The treatment aims to interrupt the immune system’s attack on the insulin-producing cells and in this way preserve the remaining endogenous insulin production at the time of diagnosis. The value of such treatment is considerable for both patients and society, as even a minor ability to produce insulin means patients find it easier to manage their blood sugar levels, which can substantially reduce future complications, such as cardiovascular diseases, renal failure and impaired vision. In addition, the risk of acute hypoglycemia, meaning low blood sugar that may lead to unconsciousness or at worst a fatal outcome, may be decreased if some of the patient’s endogenous insulin producing capacity is being preserved.


All twelve patients participating in the DIAGNODE-1 trial have now been followed for 6 months, half of the patients for 15 months and four for 30 months since start of the trial, and we can now see a disease progression suggesting the vaccine is slowing down the immune system’s destruction of the insulin-producing cells. At 6 months, the average decrease of the patients’ own insulin production measured as the stimulated C-peptide was 1.7 % (compared with 15 % in untreated patients of the same age according to published research), at 15 months 10.8% (compared with 35%), and at 30 months 32% (compared with 50% or more). This is in line with observations in our own previous trials with patients receiving placebo, inactive treatment. In the ongoing investigator initiated DIAGNODE-1, patients are on average injecting less insulin compared to at the start of the trial, and maintaining better blood sugar levels, which provides further confirmation of results suggesting that the intralymphatic treatment with the vaccine has a positive and long-term effect on the disease progression. Previously published immunological data also shows that intralymphatic treatment produces a strong and desired immunological response.


Our highest priority now is DIAGNODE-2, the follow-up placebo-controlled Phase II trial comprising a total of 80 patients, where our goal is to complete enrollment within 12 months. The first DIAGNODE-2 clinic opened for enrollment in mid-November and 15 out of 17 clinics in Sweden, Spain and the Czech Republic are now open. Information about the trial is given not only by the different clinics but also through campaigns in social media and in local newspapers.


Our commitment toward our shareholders is to increase the value of your investment. I would like to thank you for your trust and look forward to reporting on the progress of our ongoing projects.

Stockholm, January 24, 2018
Ulf Hannelius
President and CEO, Diamyd Medical AB (publ)


The last two months were dominated by new and promising results from DIAGNODE-1, the ongoing investigator-initiated trial where the diabetes vaccine Diamyd® is administered to the lymph node in recently diagnosed patients suffering from Type 1 diabetes.
Ulf Hannelius, President and CEO

Annual Report

  November 9, 2017