This is one of a series 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.
Nabi Pharmaceuticals (NABI) announced the investigational product NicVAX did not meet its primary endpoint in its first Phase 3 trial. NicVAX was being evaluated for its potential abilities to assist individuals in the cessation of smoking. Clearly this could be a significant market but NicVAX data showed that subjects quit smoking (defined as abstinence for 16 weeks ending at 12 months) at substantially the same rate as placebo. NABI traded down over 70% on the news.
Bristol Meyers Squibb Company (BMY) reported the results of a Phase 2 study of BMS-708163 in patients with mild to moderate Alzheimer's Disease. Of the four doses evaluated, two demonstrated acceptable tolerability for further development. Doses above 100mg were associated with gastrointestinal or dermotological side effects. BMS-708163 is designed to inhibit the formation of amyloid beta which is thought to contribute to the development of the disease (for more click here). BMY plans to initiate Phase 3 registrational studies of the compound.
Dynavax Technologies Corporation (DVAX) reported top-line data from a Phase 3 trial of its compound Hepislav, an investigational hepatitis B vaccine. The study compared Hepislav to Engerix-B, a currently marketed hepatitis vaccine. The study showed that Hepislav, administered in just two doses over one month, was superior to administration of Engerix-B, in a three-dose administration over six months. The study involved 2,449 healthy adults. Hepislav showed consistently, and statistically significant, higher protection rates in-vivo. There was an issue, however, with the consistency of the lots of Hepislav produced (for more click here). DVAX expects a response from the FDA shortly. As of June 30, 2011, DVAX had a record 10 million shares shorted, at six days coverage.
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.