Diamyd® in combination with etanercept and vitamin D shows safety after six months

Diamyd Medical today announced that a first six-month interim report from EDCR IIa, a clinical researcher-initiated pilot trial in which the diabetes vaccine Diamyd® is combined with the immunosuppressive drug etanercept and vitamin D, when all 20 patients have been followed for six months, preliminary shows that the treatment is safe and tolerable. No serious side effects have been reported. Professor Johnny Ludvigsson, principal investigator and sponsor for the study will present the 6-month-results tomorrow Saturday, May 20, at the Scandinavian Society for the Study of Diabetes meeting held in Nyborg, Denmark.

When all 20 patients have been followed for 6 months, a preliminary summary analysis shows that the patients’ endogenous insulin secretion, measured as C-peptide Area Under the Curve (AUC nmol/L), on average decreased by 16% and fasting C-peptide decreased by 4%. HbA1c increased on average 3% and the insulin dose increased by 7% for the patient group. The treatment has been safe and tolerable and no serious side effects have been reported.

“It is too early to draw any firm conclusions on efficacy after 6 months, but the impression is that the decrease of C-peptide, fasting or stimulated, is somewhat less than we commonly see in placebo-treated diabetic patients in the same age group,” says Professor Johnny Ludvigsson, principal investigator and sponsor of the trial. “Further follow-up is important. 

“The results at 6 months give some evidence of a possible positive effect, but the patients must be followed for a longer time for us to learn if, and how a similar combination with an immunosuppressive drug can enhance the effect of the diabetes vaccine,” says Ulf Hannelius, CEO of Diamyd Medical. “As announced, preparations are being made to start our own follow-up trial this fall, where the diabetes vaccine Diamyd® is given in the lymph node, based on preliminary results from the DIAGNODE-1 pilot trial that look very promising.”

About EDCT IIa
The Phase II trial EDCR IIa (Etanercept-Diamyd®-Combination-Regimen) is being conducted at eight pediatric diabetes clinics in Sweden. The trial is an open label clinical pilot trial in children and adolescents between 8 and 18 years of age, newly diagnosed with type 1 diabetes, in which the diabetes vaccine Diamyd® is combined with two already approved substances, etanercept and vitamin D. The patients will be followed for a total of 30 months. The aim of the study is to evaluate the safety of the combination treatment as well as its impact on the immune system.

The trial is the first of its kind, where the diabetes vaccine Diamyd® in combination with etanercept and vitamin D is tested against the complex autoimmune process causing type 1 diabetes. The trial is included in a series of combination trials with the diabetes vaccine Diamyd® aiming to enhance the effect (16%, p=0.1) previously seen in a European Phase III study including 334 newly diagnosed type 1 diabetes patients.

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®, an antigen-specific immunotherapy based on the exclusively licensed GAD-molecule. Five clinical trials are ongoing with Diamyd®. 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 Stockholm 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 08:30 CET on May 19, 2017.


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