Diamyd Medical announced topline results from DIAGNODE-1 in December 2019, showing a positive disease progression at 30 months from baseline and that an additional booster-injection given to three patients prolonged the preservation of endogenous insulin production by an additional year. The results from DIAGNODE-1 have now been fully curated by the CRO (clinical research organization) appointed to perform statistical analysis. The final results show that 12 out of 12 patients were in partial remission at 15 months (previously announced: 11 out of 12) and 9 out of 12 in partial remission at 30 months (previously announced: 10 out of 12). Compared to an expected decrease of 35-50% over a 15-month period, the endogenous insulin production decreased on average by only 19% and 40% over 15 and 30 months respectively (previously 19% and 42%). The three patients that received their fourth booster injection about 2.5 years after the start of the trial reduced their own insulin production by 30% (previously 29%) at 43 months compared to baseline. Results regarding long-term blood glucose (measured as HbA1c) and the patients’ need for externally administered insulin are as previously reported and support a positive disease progression over the full duration of the trial.

In December 2019, Diamyd Medical also announced that a comprehensive analysis of previous clinical trials showed that  a genetically defined subgroup of patients showed a clinically significant and dose-dependent response to Diamyd^®. These results will be discussed at  this week’s presentations in relation to further new insights within the diabetes field highlighting two potential subgroups (GAD3 and PAD4) of type 1 diabetes patients that have autoimmnity against either GAD or proinsulin. These subgroups are defined in the publication “Introducing the Endotype Concept to Address the Challenge of Disease Heterogeneity in Type 1 Diabetes” published in Diabetes Care in January 2020. The GAD3 group is characterized by the same genetic HLA variants that define the responder patients to the diabetes vaccine Diamyd^®. The abstract of the publication can be accessed here: https://www.ncbi.nlm.nih.gov/pubmed/31753960.

Diamyd Medical’s CEO Ulf Hannelius will present at the LSX Global World Congress on February 4, 2020 and Diamyd Medical’s founder and Board Director Anders Essen-Möller will present at Swiss-Nordic BIO in Zürich on February 6, 2020.

About Diamyd Medical
Diamyd Medical develops therapies for type 1 diabetes. The diabetes vaccine Diamyd^® is an antigen-specific immunotherapy for the preservation of endogenous insulin production. Diamyd^® has demonstrated good safety in trials encompassing more than 1,000 patients as well as significant effect in some pre-specified subgroups. Results from the Company’s European Phase IIb trial DIAGNODE-2, where the diabetes vaccine is administered directly into a lymph node in children and young adults with newly diagnosed type 1 diabetes, are expected to be presented in the third quarter of 2020. Diamyd Medical also develops the GABA-based investigational drug Remygen^® for regeneration of endogenous insulin production. An investigator-initiated Remygen^® trial in patients living with type 1 diabetes for more than five years is ongoing at Uppsala University Hospital. Diamyd Medical is 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.

Diamyd Medical’s B-share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company’s Certified Adviser; phone: +46 8-528 00 399, e-mail: info@fnca.se.

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: https://www.diamyd.com

The information was submitted for publication, through the agency of the contact person set out above, at 13.30 CET on February 3, 2020.