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 (OTC:DMYDY) 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 first quarter of 2011. Market cap is $4.6 billion and short interest is about 7 million shares, or about 4.5 times current average daily volume.
Medicago, Inc. (OTC:MDCGF), a firm focused on vaccine research, reported positive results from a Phase 2b trial of its H5N1 Avian Flu Vaccine. The vaccine induced a good immune response and was found to be safe and well tolerated. Phase 2b results confirmed the Phase 2a results but also confirmed that it had similar affects in older and younger patients, those most at risk from the flu. MDG is also pursuing development of a seasonal flu vaccine. MDG is currently followed by one US based firm, Roth Capital Partners, which rates it a buy with a 12-month price target of $1.41
These clinical updates are short summaries and should be used as a basis for futher research. You should always perform your own due diligence. Many factors can determine whether a particular drug candidate will ever come to market or be profitable and biotech investing should be considered very high risk.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
