Biotech Clinical Trials Update

Includes: EBS, SHPG
by: Roger Newman

This is one in a series (click here) of articles that highlight recent clinical trial updates for new drugs in the FDA approval process. A brief overview of the FDA approval process can be found here.

Emergent Biosolutions Inc. (NYSE:EBS) reported results from a Phase 1a trial evaluating CPG-7909 as an addition to treatment with BioThrax, the only FDA-licensed anthrax vaccine. The trial results showed that administration of CPG-7909 mixed with BioThrax at bedside generated peak antibody responses that were six times higher than with BioThrax alone. CPG-7909 also accelerated the time to peak immune response by three weeks. This is important due to the potential for rapid disease progression with anthrax poisoning and its potential use as a weapon (click here for more). EBS is traded on the NYSE and has a market cap of $600 million.

Shire plc (SHPGY) reported results from its pivotal Phase 3 trial of Dermagraft in subjects with venous leg ulcers. Dermagraft is currently approved for use in the treatment of diabetic foot ulcers. This study would expand the approved indications. The trial of 500 patients in eight countries did not meet its primary endpoint (complete healing by 16 weeks). Shire has decided not to pursue the additional indication for Dermagraft. Shire acquired the rights to Dermagraft in May, 2011 when it purchased Advanced BioHealing, Inc. (click here). Advanced BioHealing had previously scheduled and IPO (click here).

These clinical updates are short summaries and should be used as a basis for further 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 high risk.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.