Biotech Clinical Trials Update

Includes: BDSI, VRTX
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.

BioDelivery Sciences International (NASDAQ:BDSI) announced results from its Phase 1 trial of a BEMA Buprenorphine/Naxolone combination for the treatment of opoid dependence. The study assessed absorption profiles vs. the FDA approved opoid dependence treatment, Suboxone. Results showed that the combination met the key goal of producing sufficient concentrations of buprenorphine in the system to treat opoid dependence. Suboxone is the most widely used treatment for opoid dependence and generates growing sales of more than $1 billion per year. BEMA is a drug delivery technology that consists of a small film that is applied to the inside of the cheek (click here). BDSI is a $100 million market cap company with just over seven days volume sold short (click here).

Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) reported results from a Phase 2a trial of its compound VX-509 for treatment of rheumatoid arthritis (RA). The compound produced substantial and statically significant improvements in several measures. The study met its two primary endpoints: Improvement in a proportion of patients who achieved at least a 20% improvement in signs and symptoms of RA and a statistically significant improvement in Desease Acvitivty Score 28 (click here). VX-509 will continue development in a Phase 2b trial in conjunction with methotrexate (click here). VRTX is traded on Nasdaq and has a market cap of over $9 billion.

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.