The GABA/Diamyd® trial in the US fully recruited this summer

In the placebo-controlled combination trial GABA/Diamyd® conducted at University of Alabama at Birmingham, US, 82 patients have now been included, of which 48 have completed the entire trial. No serious side effects have been reported and the treatment appears to be safe. The trial is expected to be fully recruited this summer.

GABA/Diamyd® is a three-arm, double-blind and placebo-controlled trial including a total of 95 children and adolescents between 4 and 18 years, recently diagnosed with type 1 diabetes. The patients are randomly assigned to one of three treatment groups: a) two injections with Diamyd® in combination with oral treatment with GABA, b) GABA only, or c) placebo. Patients are followed for 12 months after which the effect on the preservation of the endegenous insulin production will be analyzed. The trial is conducted in the United States and led by Professor Kenneth McCormick at University of Alabama at Birmingham, Principal Investigator and Sponsor of the trial. Dr. McCormick treats patients at Children’s of Alabama.

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. Diamyd® has demonstrated good safety in studies with more than 1,000 patients as well as effect in some pre-specified subgroups. Besides the Company’s own European Phase-II trial DIAGNODE-2, where the diabetes vaccine is administered directly into the lymph node, there are four investigator initiated clinical trials ongoing with Diamyd®. Diamyd Medical also develops Remygen™, an oral GABA-based study drug. An investigator initiated placebo controlled trial with GABA and Diamyd® in patients recently diagnosed with type 1 diabetes is ongoing at the University of Alabama at Birmingham. Exclusive licenses for GABA and positive allosteric modulators of GABA receptors for the treatment of diabetes and inflammatory diseases constitutes alongside with the diabetes vaccine Diamyd® and Remygen™ key assets. Diamyd Medical is also one of the major shareholders in the stem cell company NextCell Pharma AB and 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 February 22, 2018.


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