Two doses of Diamyd® show safety in 5-year prevention trial in children at high risk for type 1 diabetes

Diamyd Medical today announces final results from DiAPREV-IT 1, a placebo-controlled clinical pilot trial led by Associate Professor MD Helena Elding Larsson, Lund University, where the diabetes vaccine Diamyd® for the first time is given to a group of individuals at high risk of developing type 1 diabetes. Overall, the results show that the treatment was safe and tolerable, and that fewer subjects than expected, 16 out of 50 compared to expected 25 out of 50, had developed type 1 diabetes in the 5-year follow-up of the trial. However, no significant difference was seen between children receiving placebo and those who received the active substance. The trial results were presented yesterday evening, local time, by Associate Professor Elding Larsson at the Diabetes Conference of the American Diabetes Associations (ADA) 77th Scientific Sessions in San Diego, USA.

"We saw good safety and the treatment did not negatively affect the children's insulin production. However, we could not prove that the treatment delayed or prevented children from developing type 1 diabetes," says Helena Elding Larsson, Principal investigator and Sponsor of the trial. “The trial is small and since fewer individuals than expected developed type 1 diabetes during the period, it may have affected the ability to detect differences in treatment effect. It is positive that the results show that Diamyd® is also safe to give to children who have not yet developed type 1 diabetes. We will now proceed to analyze the large amounts of mechanistic data collected over the years and to plan how we will follow up this trial.”

"The results appear to be in line with what we have seen in newly diagnosed patients where a few doses of subcutaneous administration of Diamyd® alone do not have the effect required to show significant differences," says Ulf Hannelius, CEO of Diamyd Medical. “The long follow-up and safety shown by Diamyd® in a young high-risk population, provides further possibilities for continued evaluation of the effect of the diabetes vaccine as a preventive treatment, either as part of a combination therapy, such as the ongoing DiAPREV-IT 2 trial, where Diamyd® is given together with vitamin D, or with intralymphatic administration where we see very promising preliminary results in newly diagnosed patients.”

No serious side effects were reported. Levels of GAD autoantibodies increased significantly (p = 0.0014) in those who received Diamyd® compared to placebo and remained elevated for up to 27 months after treatment, indicating that the treatment evokes an immunological response. The treatment did not affect the other beta cell autoantibodies, nor did it increase the prevalence of antibodies indicating other autoimmune diseases. No significant difference between the groups was observed regarding time to diagnosis.

DiAPREV-IT 1 is a placebo-controlled trial initiated by Lund University where Diamyd® for the first time is being tested in children at high risk of developing type 1 diabetes, meaning that they have been found to have an ongoing autoimmune process but do not yet have any clinical symptoms of diabetes. The trial comprises 50 participants from the age of four and has lasted for five years. The aim of the trial is to evaluate the safety of two doses Diamyd® administered subcutaneously to children at high risk for type 1 diabetes, and whether it can delay or prevent the participants from developing type 1 diabetes.

About Diamyd Medical
Diamyd Medical is dedicated to finding a cure for diabetes and other serious inflammatory diseases through pharmaceutical development and investments in stem cell and medical technology.

Diamyd Medical develops the diabetes vaccine Diamyd®, for antigen-specific immunotherapy based on the exclusively licensed GAD-molecule. Four clinical trials are ongoing with Diamyd®. The Company's trial DIAGNODE-2, where the diabetes vaccine is administered directly into the lymphatic node, is expected to start recruiting patients in the fall. GABA constitutes alongside with the diabetes vaccine a key asset in Diamyd Medical and the Company uses its GABA in-licensed technology to develop a proprietary GABA drug product. Diamyd Medical is one of the major shareholders in the stem cell company NextCell Pharma AB. Diamyd Medical also has holdings in the medtech company Companion Medical, Inc., San Diego, USA and in the gene therapy company Periphagen, Inc., Pittsburgh, USA.

Diamyd Medical’s B-share is traded on Nasdaq First North under the ticker DMYD B. FNCA Sweden AB is the Company’s Certified Adviser.

For further information, please contact:
Ulf Hannelius, President and CEO
Phone: +46 736 35 42 41
E-mail: ulf.hannelius@diamyd.com

Diamyd Medical AB (publ)
Kungsgatan 29, SE-111 56 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8 661 63 68
E-mail: info@diamyd.com. Reg. no.: 556242-3797. Website: www.diamyd.com.

This information is information that Diamyd Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:17 CET on June 13, 2017.


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