The US biotech saw a recent Phase II trial generate poorer than anticipated results after a change in protocol from earlier studies meant that the syringes used were too short to adequately inject the trial drug through the adipose tissue in the arms of overweight patients.

According to the Financial Times (FT), two thirds of the 313 patients participating in the global trial did not receive an adequate injection of the drug into the muscle, with the largest chunk of these patients coming from the US, where the high prevalence of obesity is well documented.

As a result, the Phase II study data of the BioCryst's experimental flu injection, Peramivir, showed a non-statistically significant improvement in reducing flu symptoms.

Earlier trials had generated more positive results when the protocol has specified the use of syringes with 1.5 inch needles, however, for this most recent study, staff switched them for syringes with 1.0 inch needles in a bid to minimise patient discomfort.

Despite the debacle and the modest Phase II efficacy data, Biocryst believes it has generated enough safety data from the Phase II trial and does not plan to repeat it - instead, it will immediately press on with its Phase III programme. The firm is lucky that the situation didn't arise during this later phase in clinical development, as the consequences could have been very different.

Still, it is an important lesson that those in the drug development business, particularly smaller biotechs with limited experience, will do well to take note of as clinical trials are a very costly and timely endeavour and any unnecessary mistakes or delays in the process, especially the late phase, could spell disaster for a new drug's development programme.