Synergen's Future Appears Rocky After Antril Failure

Synergen has stopped its follow-up trial of Antril (anakinra) for severe sepsis, after an interim analysis of data showed a lack of efficacy for the product. The follow-up trial was continued despite the fact that an earlier trial (Marketletter June 20) showed no significant increase in survival time compared to placebo.

According to the company, an independent safety and efficacy committee recommended the move even though the analysis showed no safety concerns. A retrospective analysis of the earlier trial had indicated a reduction in mortality for patients with organ dysfunction (adult respiratory distress syndrome, disseminated intravasular coagulation or renal dysfunction) and/or shock. These results were not reproduced in the current trial even though the company had said after the previous trial that the organ dysfunction data should enable it to tighten up enrollment criteria, thereby enhancing the odds for a successful follow-up trial.

Analysts' Reactions The market and company shares reacted strongly to the news, with the stock dropping nearly half of its value to close around $4.50 at the beginning of last week, compared to its peak of just over $66 in December 1992. Many market observers feel that the stock now has very limited options.