shares plummeted early Monday after the drugmaker reported mixed late-stage data on its diabetes treatment prospect VIAject.
The trials met their primary endpoint, but data varied considerably between study sites -- with "medically improbable" results in data collected from treatment sites in India.
Aside from the data anomalies, the Danbury, Conn., company said 24 patients dropped out of the study due to injection-site pain -- an issue that it says that may be resolved by changing the volume of the VIAject formulation.
Shares were sliding $11.39, or 66.8%, to $5.65 in recent trading Monday.
At a conference in Rome, the company shared results from two pivotal late-stage studies designed to determine whether VIAject was non-inferior to Humulin, a regular human insulin in managing blood glucose levels in patients with Type I and Type II diabetes. The studies measured blood glucose by the mean change in HbA1c, a measurement of blood glucose, from the baseline.
The trials were conducted in the U.S., Germany and India. Both trials met the primary goal of the study with a change in HbA1c that was comparable between the arms, according to Biodel.
The company said that patients with both Type I and Type II diabetes receiving VIAject gained an average of 0.7lbs over 26 weeks, while those on Humulin gained 3.7lbs -- the difference was statistically significant.
In the trial with Type I diabetes patients, however, Biodel said a statistically significant interaction associated with the data from India means the results cannot be compared to the U.S. data. Thus, those efficacy data aren't included in the preliminary analyses.
Biodel said the data weren't comparable because of a marked increase in HbA1c levels both before and after the patients started the drug, effectively doubling the variability in the HbA1c results before and after the drug was started (a medical improbability), as well as markedly fewer reports of hypoglycemic events.
"These data anomalies were observed in both the VIAject and RHI (Humulin) treatment groups and are under investigation," said the company in a release Monday. The company said that it believes the data will ultimately have to be left out of consideration for non-inferiority because they are not valid.
However, because the company has yet to identify why the data are different they can't be written off. And, if the results from India, which increase variability, are included, the overall results don't show non-inferiority -- the goal of the study.
Geographic variability aside, the company also said that 24 patients who received VIAject dropped out of the two studies due to injection-site pain. "Injection site pain may be related to the four-times greater volume of VIAject used to achieve an equivalent dose of RHI (Humulin)," noted the company in the release. The concentration of VIAject was 25 IU/ml, while the concentration of Humulin was 100 IU/ml.
Biodel has developed a liquid 100 IU/ml formulation of VIAject that it says may reduce the incidence of injection-site pain because it would lower the injection volumes.