Diamyd® in combination with etanercept and vitamin D shows safety in a first preliminary interim report

Diamyd Medical (Nasdaq Stockholm First North, Ticker: DMYD B) today announced that a first six-month interim report comprising five patients in EDCR IIa, a pilot researcher-initiated clinical study in which the diabetes vaccine Diamyd® is combined with two other already approved agents, the immunosuppressive drug etanercept and vitamin D, preliminary shows the treatment is safe and tolerable. No serious side effects have been reported. This is the first time that this combination of agents is tested against the complex autoimmune process that causes type 1 diabetes.

EDCR IIa (Etanercept-Diamyd®-Combination-Regimen) is an open label clinical pilot study 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 etanercept and vitamin D. The aim of the study is to evaluate the safety of the combination treatment as well as its impact on the immune system. The study is led by Professor Johnny Ludvigsson, principal investigator and sponsor of the study. The study is included in a series of combination studies with the diabetes vaccine Diamyd® to enhance the effect (16%, p=0.1) previously seen in a European Phase III study including 334 newly diagnosed type 1 diabetes patients.

Today a total of 13 of 20 patients are included in the EDCR IIa study and now the first preliminary safety data from the five first patients who have been followed for six months, i.e. five months after the first of two injections of the diabetes vaccine Diamyd®, are presented.

Professor Johnny Ludvigsson reports that preliminary data for the five patients, with an average age of 11.6 years, who have been monitored for six months, indicates good safety and no serious side effects have been reported. As for diabetes variables, such as endogenous insulin secretion, HbA1c (a way of measuring long-term blood sugar) and insulin dose, the number of patients are too few, and the duration – 5 months after the first injection of Diamyd® – is too short to draw any conclusions. Immunological parameters have not yet been evaluated.

“In these few patients we can see that the treatment seems tolerable and that no serious side effects have been reported, which is important for a new combination treatment of this kind,” says Professor Johnny Ludvigsson at Linköping University, principal investigator and sponsor of the study. “We are testing a new exciting concept to use etanercept to suppress harmful parts of the immune system that are activated in new onset type 1 diabetes and simultaneously, in a discrete antigen-specific fashion, want to induce tolerance with the diabetes vaccine Diamyd®. Before any meaningful conclusions of the treatment effect on the diabetes status can be drawn, more patients monitored for a longer period of time must be evaluated. We will now continue to include the remainder of the participants to the study and follow them for 6, 15 and 30 months.”

Etanercept is a so called TNF-alpha inhibitor used in rheumatic diseases, for example for treating children with juvenile idiopathic arthritis (JIA). Data from previous clinical trials shows that Diamyd® activates both components that down-regulate the immune system as well as components that increase inflammation in type 1 diabetes. By combining the diabetes vaccine with etanercept, the inflammatory response is reduced and the diabetes vaccine’s down-regulating, tolerance-inducing effect can have a greater impact. In turn, Vitamin D further down-regulates the immune system’s inflammatory components in order to strengthen the efficacy of the diabetes vaccine. Vitamin D and etanercept are both also considered to have a direct positive effect on the beta cells.

EDCR IIa is pursued at nine pediatric diabetes clinics in Sweden.

About Diamyd® and combination trials
Type 1 diabetes is a devastating disease which requires daily treatment with insulin to sustain life. The importance of finding a cure should not be underestimated. The diabetes vaccine Diamyd® has been used in clinical studies with more than 1,000 patients and has shown a good safety profile. In a European Phase III trial Diamyd® showed good clinical effect in several subgroups, and a limited overall 16% efficacy (p=0.10) in preserving endogenous insulin secretion. Subsequent development is focused on combination trials to enhance efficacy. Diamyd® is easy to administer in any clinical setting. The potential annual market is estimated to several billion dollars per year.

Six researcher initiated clinical trials are ongoing combining Diamyd® with various other immunomodulatory compounds; etanercept, ibuprofen, vitamin D and GABA.

• DIABGAD-1 – COMBINING DIAMYD® WITH IBUPROFEN AND VITAMIN D

A placebo-controlled trial, where Diamyd® is being tested in combination with ibuprofen and vitamin D. The trial comprises a total of 64 patients between the ages of 10 and 18, recently diagnosed with type 1 diabetes, and will continue for a total of 30 months. The aim of the combination treatment is to preserve the body’s own capacity to produce insulin. The trial runs at nine clinics in Sweden and is led by Professor Johnny Ludvigsson at Linköping University, Sweden. 30 month results from the trial are due during the first half year of 2017.

• DIAGNODE-1 –DIAMYD® IN LYMPH GLANDS IN COMBINATION WITH VITAMIN D

An open label trial, where Diamyd® is administered directly into lymph nodes in combination with treatment with vitamin D. The trial comprises five patients between the ages of 18 and 30 newly diagnosed with type 1 diabetes, and will continue for a total of 30 months. The aim of the trial is to evaluate the safety of the combination treatment and the effect on the immune system and the patients’ insulin producing capacity. The trial is led by Professor Johnny Ludvigsson at Linköping University, Sweden. The first patient was included in the trial in February 2015. A study-expansion application has been submitted to the Swedish Medical Products Agency and the Ethics Review Board.

• GABA/DIAMYD® – COMBINING DIAMYD® WITH GABA

A placebo-controlled trial, where Diamyd® is being tested in combination with GABA. The trial comprises 75 patients between the ages of 4 and 18 recently diagnosed with type 1 diabetes, and will continue for a total of 12 months. The aim of the combination treatment is to preserve the body’s residual capacity to produce insulin. The trial is led by Professor Kenneth McCormick at the University of Alabama at Birmingham, USA. The first patient was included in the trial in March 2015.

• EDCR IIa – COMBINING DIAMYD® WITH ETANERCEPT AND VITAMIN D

An open label trial, where Diamyd® is combined with etanercept and vitamin D. The trial comprises 20 patients between the ages of 8 and 18 who have been newly diagnosed with type 1 diabetes, and will continue for a total of 30 months. The aim of the trial is to evaluate the safety of the combination treatment and the effect on the immune system and the patients’ insulin producing capacity. The trial is led by Professor Johnny Ludvigsson at Linköping University, Sweden. The first patient was included in May 2015.

• DiAPREV-IT 1– DIAMYD®

A placebo-controlled trial, where Diamyd® 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. A total of 50 participants from the age of four have been enrolled in the trial, which will last for five years. The aim of the trial is to evaluate whether Diamyd® can delay or prevent the participants from presenting with type 1 diabetes. The trial is led by Dr. Helena Elding Larsson at Lund University, Sweden. Five year results are expected at the end of 2016.

• DiAPREV-IT 2 – COMBINING DIAMYD® WITH VITAMIN D

A placebo-controlled trial, where Diamyd® is being tested in combination with vitamin D 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. A total of 80 participants between the ages of 4 and 18 will be enrolled in the trial, which will last for five years. The aim of the trial is to evaluate whether Diamyd® can delay or prevent the participants from presenting with type 1 diabetes. The trial is led by Dr. Helena Elding Larsson at Lund University, Sweden. The first patient was included in March 2015.

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

Diamyd Medical develops the diabetes vaccine Diamyd®, an Antigen Based Therapy (ABT) based on the exclusively licensed GAD-molecule. The Company’s licensed technologies for GABA and Gliadin have also potential to become key pieces of the puzzle of a future solution to prevent, treat or cure autoimmune diabetes, and also certain inflammatory diseases. At this time six clinical studies are ongoing with Diamyd®. Diamyd Medical is with its holdings of 45% one of the major shareholders in the stem cell company Cellaviva AB. Stem cells can be expected to be used in Personalized Regenerative Medicine (PRM), for example for restoration of beta cell mass in diabetes patients where the autoimmune component of the disease has been arrested. 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. Remium Nordic AB is the Company’s Certified Adviser.

For further information, please contact:
Anders Essen-Möller, President and CEO
Phone: +46 70 55 10 679. E-mail: anders.essen-moller@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.

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