This is one of a continuous series of articles that will highlight selected recent clinical trial updates for new drugs in the FDA approval process. A brief overview of the FDA approval process can be found here.
Diamyd Medical AB (DMYDY.PK) presented results of a Phase 2 study with Diamyd, a antigen-based diabetes therapy. Development has been ongoing since 1994 when Diamyd licensed patents from the University of California in Los Angeles. The study did not reach the primary efficacy endpoint of preserving insulin production in patients who had recently (within three months) been diagnosed with type 1 diabetes. The goal of the study was to show that Diamyd allowed early-stage type 1 diabetics to maintain insulin production despite having the disease. This came after a June 23 announcement that Diamyd Medical moved to close a Phase 3 study in the US of the same compound due to its failure to meet primary endpoints in a European Phase 3 study. The company is currently running a Phase 2 study with Diamyd attempting to prevent type 1 diabetes in high risk children. That study will continue. DMYDY is very lightly traded on the pink sheets.
Endo Pharmaceuticals (ENDP) reported top line results from a Phase 2 study of axomadol. The study enrolled 236 patients with moderate to severe lower back pain and the primary outcome measure was improvement in average pain intensity. Axomadol did not meet its primary endpoint. The compound had been licensed in the US and Canada from Gruenthal. ENDP is a well developed biotech with numerous agents on the market, 2 NDA's pending, 2 Phase 3 trials and one other compound in Phase 2 trials, in addition to numerous earlier stage initiatives. ENDP is perhaps best known for its lineup of pain medications including Percoset, Percodan and Endocet. ENDP is a profitable company with over $360MM in revenues in the
