Diamyd Medical's Antigen-Based Therapy Diamyd Fails to Meet Primary Efficacy Endpoint in Type 1 Diabetes Clinical Trial

Strategic Insights -

Diamyd Medical AB, a Swedish pharmaceutical company, has announced that its antigen-based therapy Diamyd has failed to meet the primary efficacy endpoint in a European phase III clinical trial for newly diagnosed type 1 diabetes patients. The trial, which enrolled over 320 patients between the ages of 10 and 20, aimed to preserve beta cell function in patients with type 1 diabetes. However, the results showed that Diamyd did not show statistically significant preservation of beta cell function after 15 months of follow-up. Despite the lack of significant results, the company notes that Diamyd was well tolerated and a small positive effect was registered. This failure has significant implications for the company's plans to advance the program, particularly in light of a development and commercialization deal with Ortho-McNeil-Janssen Pharmaceuticals Inc, a subsidiary of Johnson & Johnson.

Key Takeaways:

  • The European phase III clinical trial for Diamyd did not meet its primary efficacy endpoint, failing to show statistically significant preservation of beta cell function in patients with type 1 diabetes.
  • The trial enrolled over 320 patients between the ages of 10 and 20, with three treatment arms: one-third received four subcutaneous injections of Diamyd, one-third received two injections, and one-third received placebo.
  • Diamyd was found to be well tolerated, with a similar number of adverse events across the different treatment groups.
  • A small positive effect was registered, but not statistically significant.
  • The company will further analyze the results and data from other ongoing trials to decide on the best way to advance the program.
  • Diamyd Medical had hoped for a better outcome in the European study and will continue to review options for advancing the program, including an ongoing US phase III trial for DiaPrevent.
  • The trial results will be presented at the American Diabetes Association's 71st Scientific Sessions in June 2011.
  • The company has a development and commercialization deal with Ortho-McNeil-Janssen Pharmaceuticals Inc, part of Johnson & Johnson, which may take full responsibility for the global development of Diamyd after reviewing the phase III results.

Statistics:

  • The trial enrolled over 320 patients between the ages of 10 and 20.
  • The trial had three treatment arms: one-third received four subcutaneous injections of Diamyd, one-third received two injections, and one-third received placebo.
  • The trial had a 15-month follow-up period.
  • The phase III trial in the US, DiaPrevent, is expected to be completed in the summer of 2012.
  • The development and commercialization deal with Ortho-McNeil-Janssen Pharmaceuticals Inc is valued at an undisclosed amount.

Sources:

  • NORDIC BUSINESS REPORT via COMTEX
  • M2 COMMUNICATIONS