Coronado Biosciences' ($CNDO) mid-stage trial of its experimental drug for Crohn's disease flopped in a mid-stage study. And while the biotech pointed to an unexpected placebo response and the possibility of finding something positive after some further analysis of the data, its stock cratered on the news, plunging 70%.
The Burlington, MA-based biotech recruited 250 patients for its study of CNDO- 201 (TSO), but investigators say that it failed both its primary and secondary endpoints on disease activity and remission. "In the corresponding pre-defined subset analysis, TSO showed a non-significant improved response in patients with CDAI>290 (the disease activity index)," reported the company. "The lack of overall response was driven by higher-than-expected placebo response rate in patients with CDAI."
TSO is made up of the microscopic eggs of pig whipworms, which some researchers believe can recalibrate the immune system in order to damp down the kind of inflammatory response that causes a disease like Crohn's.
"While we are disappointed with the topline results, we are encouraged to see TSO's effect in patients with CDAI > 290. These results support the potential of TSO to regulate the immune system in patients with Crohn's disease, particularly those with higher level of disease severity," said Coronado CEO Harlan Weisman. "We look forward to further analyzing the data from TRUST-I, along with the anticipated data from Dr. Falk Pharma's TRUST-II study in Crohn's disease, to identify the most appropriate development path for TSO."
Dr. Falk Pharma GmbH, the biotech's development partner, is managing TRUST-II, a mid-stage study of three different doses. The results are expected later in this quarter.
- here's the release