Diamyd Medical agrees on new GABA/GAD study
Diamyd Medical (Nasdaq Stockholm First North, Ticker: DMYD B) today announced that the Company has signed an agreement with Uppsala University and Uppsala University Hospital to conduct a clinical study with the diabetes vaccine Diamyd® combined with one or several GABA-related substances for which the stem cell researcher Professor Per-Ola Carlsson will be the Principal Investigator.
The planned researcher-initiated combination study will be discussed with the Swedish Medical Products Agency this spring and is the first of its kind where GABA combined with the diabetes vaccine Diamyd® will play a large role in the treatment of type 1 diabetes patients who have had the disease for a longer period of time but still have some residual insulin secretion left. It differs thereby from other studies where the treatment usually is initiated early in the disease process.
Professor Per-Ola Carlsson, stem cell researcher and endocrinologist at Uppsala University Hospital will be the Principal Investigator of the study, while Uppsala University will be represented by the GABA expert Professor Bryndis Birnir, who is also a member of Diamyd Medical’s Scientific Advisory Board.
“The research around GABA and GABA-related drugs and how these affect endogenous insulin secretion has been our main focus for the last couple of years, and we have now reached a point where we can transfer this to clinical studies, the goal for our team for a long time,” says Professor Bryndis Birnir, Department of Neuroscience; Physiology; Molecular Physiology and Neuroscience at Uppsala University.
The intention is that the GABA-related molecules will support beta cell function and simultaneously decrease the autoimmune inflammation so that a fertile milieu is generated for the GAD-based Antigen Based Therapy Diamyd® to induce tolerance for a longer period of time.
“This new concept, to attack type 1 diabetes with both GAD and GABA-related drugs is interesting,” says Professor Per-Ola Carlsson, Department of Medical Cell Biology, Uppsala University and Department of Medical Sciences, Transplantation and Regenerative Medicine, Uppsala University Hospital. “If we with this regimen can stop the autoimmune attack on the insulin-producing beta cells, it may, together with our other approach – to increase beta cell mass through transplantation with autologous stem cells – eventually become what will lead to a cure for the disease.”
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.
- 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. A first interim report is planned in the first quarter of 2016.
- 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 39% 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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