Diamyd Medical was able to start the New Year by announcing that more than half of the planned total of 60 patients in the DIABGAD-1 study had been enrolled. Children and adolescents with newly diagnosed type 1 diabetes are currently being recruited to the study at about ten pediatric diabetes clinics throughout Sweden. Enrolment of the final patients is expected to be completed by summer 2014, and presentation of the initial results from the study is expected in 2015. The study is being led by Professor Ludvigsson at Linköping University.
In the DIABGAD-1 study, our diabetes vaccine Diamyd® is being combined with the anti-inflammatory drug ibuprofen and relatively high doses of vitamin D to investigate whether the treatment can preserve the patients’ endogenous insulin production. Even a modest degree of endogenous insulin production reduces the risk of acute and long-term diabetes complications.
The Swedish researcher-initiated DiAPREV-IT study started in 2009 and aims to evaluate whether the diabetes vaccine Diamyd® can prevent or delay type 1 diabetes in children who are at high risk of developing clinical symptoms of the disease. The initial results from the DiAPREV-IT-study are also expected in 2015.
Additional researcher-initiated studies involving the diabetes vaccine Diamyd® are being discussed with various researchers groups and newly produced diabetes vaccine is now available for new studies. For example, a trial is being planned in the US in which the intention is to combine Diamyd® with GABA. The combination has shown favorable results in preclinical studies and the Company has in-licensed the rights for the use of GABA in connection with diabetes and other inflammation-related conditions. The study protocol and an agreement between Diamyd Medical and the researchers’ university must be finalized before an application can be submitted to the US Food and Drug Administration (FDA).
Professor Ludvigsson’s research group is continuing to analyze the extensive material collected in the earlier European Phase III study and an earlier Swedish Phase II study of Diamyd®. In December 2013, they published a scientific paper relating to the analysis of results from 148 Swedish children and adolescents with type 1 diabetes who participated in the earlier studies. The authors’ conclusion is that treatment with two doses of the GAD-based diabetes vaccine is safe and that, versus placebo, it preserves insulin production 30 months after treatment (GAD-treatment of children and adolescents with recent-onset Type 1 diabetes preserves residual insulin secretion after 30?months, Diabetes Metab Res Rev. 2013 Dec 3. Epub ahead of print). Such new analyses based on the substantial database with patient data that Diamyd Medical has compiled over the years, add to strengthen the interest in the diabetes vaccine and researcher-initiated studies of Diamyd®.
On the second trading day of the year, the Diamyd share rose by 30 percent during heavy trading after widespread distribution of a newspaper article about the so called TEDDY study. The article described the TEDDY study, in which researchers are closely monitoring thousands of children from birth to ascertain who will and who will not develop type 1 diabetes, with the purpose of determining what triggers type 1 diabetes. To clarify for the stock market that the diabetes vaccine Diamyd® is not being tested as part of the TEDDY study, the company published a press release, after which the share price declined again.
In December, I was in Lorne in Australia and attended the scientific IDS conference dedicated to diabetes immunology research. The conference is an ideal opportunity to hear about the latest findings and to network with leading researchers in the field. In his opening plenary lecture, Doctor Jay Skyler described how the key to successfully treating type 1 diabetes will be to attack the disease from several angels simultaneously by combining various therapeutics, and that an autoantigen-specific treatment such as Diamyd® will constitute an essential component in future combination therapies.
Stockholm, January 22, 2014
President and CEO Diamyd Medical AB (publ)