Following an intense autumn with many positives, Diamyd Medical was able to start the New Year with yet more good news. On January 6, 2015, the United States Patent and Trademark Office granted a new patent for GAD65 for the treatment of autoimmune diseases, including diabetes. The GAD65 protein is the active substance in the Diamyd® diabetes vaccine and Diamyd Medical has an exclusive license for the new patent from the University of California, Los Angeles (UCLA). The term of the new patent runs into January 2032, which is more than ten years longer than previous US patent protection for the diabetes vaccine. The longer term should provide time for the remaining development of Diamyd® and many years of marketing in the US without competition. Diamyd® is the furthest developed Antigen Based Therapy for type 1 diabetes in the world.
In December, two new batches of GAD65 protein were manufactured by Protein Sciences in the US. Preliminary analyses indicate that the production went well even if much analytical work remains before the material can be released for use. In accordance with the production agreement from September 2014, Diamyd Medical has issued 100,000 Series B shares to Protein Sciences. Protein Sciences will receive a further 300,000 Series B shares upon release of the material. In addition, a cash amount was paid to Protein Sciences for the manufacturing, which explains the higher costs for the period compared with earlier periods.
The end product Diamyd® is comprised of GAD65 protein from Protein Sciences formulated with the vaccine adjuvant alum. Thus far, the formulation has been done in batches of 3,000 vials by Octoplus in the Netherlands, however, they have recently informed their clients that they plan to phase out their contract manufacturing services. We have a large stock of ready-for-use diabetes vaccine that will suffice until autumn 2017 for all studies, so we have plenty of time to select a new contract manufacturer for the final formulation.
The initial results of the DIABGAD-1 combination study are expected to be presented in the spring. The study encompasses a total of 64 patients between the ages of ten and 18 who have been recently diagnosed with type 1 diabetes. The study will continue for a total of 30 months, but an initial evaluation will take place now after six months with focus on immunological markers. The immunological markers can provide an indication of how the treatment has affected the immune system. However, in this patient group, six months is too short a time for relevant differences to arise between the treatment groups in terms of the clinically most interesting variables, for example, the patients’ ability to produce insulin. The 15-month results from the study, that may be available by the end of 2015, will show what effect the treatment has had on the ability to produce insulin.
DIABGAD-1 is a researcher-initiated study with the Diamyd® diabetes vaccine, in which a group of participants also receive the anti-inflammatory substance ibuprofen. In addition, several of the groups of participating children receive vitamin D to further steer the immune system in the right direction and, concurrently, strengthen the beta cells. The aim of the combination treatment is to preserve the body’s remaining capacity to produce insulin. The study is taking place at nine clinics in Sweden and is led by Professor Johnny Ludvigsson at Linköping University.
In addition to DIABGAD-1, the researcher-initiated DiAPREV-IT study is ongoing in southern Sweden and its results are expected at the end of next year. The study comprises 50 children that have been found to have an ongoing autoimmune process, but do not yet have any clinical symptoms of diabetes, and aims to evaluate whether treatment with Diamyd® can delay or prevent the participants from presenting with type 1 diabetes. In the autumn, four new researcher-initiated studies with the Diamyd® diabetes vaccine were approved in Sweden and the US. Intense efforts are ongoing with getting these studies started and we expect several of them to start recruiting participants in the first quarter of 2015.
Stockholm, January 21, 2015
President and CEO Diamyd Medical AB