Shares in Coronado Biosciences plummeted as much as 70 percent Monday after the company reported top-line Phase II results showing that its natural immunomodulator TSO (Trichuris suis ova) missed the study's main goal of improving response in patients with moderate-to-severe Crohn's disease, compared with placebo. CEO Harlan Weisman said the company plans to further analyse results from the TRUST-I trial, along with anticipated mid-stage data from a study conducted by partner Dr. Falk Pharma, "to identify the most appropriate development path for TSO."
In the TRUST-I study, 250 patients with moderate-to-severe Crohn's disease were randomised to receive TSO, which is also known as CNDO-201, or placebo every two weeks for 12 weeks. The primary endpoint was the induction of response at 12 weeks, as assessed by a decrease of at least 100 points in the Crohn's Disease Activity Index (CDAI). The key secondary goal of remission, which was also missed, was defined as achieving a CDAI of at least 150 points or less.
According to MLV & Co. analyst Graig Suvannavejh, "people thought that if it was going to have a good shot at success, Crohn's disease was where it was going to see good results," while Joseph Pantginis of Roth Capital indicated there is no chance of TSO succeeding in that indication. Pantginis said he is also less optimistic about TSO's outlook as a potential treatment for ulcerative colitis and multiple sclerosis. The drug is also currently in mid-stage testing in those two diseases, as well as for autism."We believe Coronado is unfortunately entering a state of limbo as investors await what the next steps will be with this significant blow to confidence in the TSO programme," he said.
Still, the company noted that there was a non-significant improvement in response among TSO-treated patients whose CDAI was greater than 290 in the trial, which Weisman suggested supports "the potential of [the drug] to regulate the immune system in patients with Crohn's disease, particularly those with [a] higher level of disease severity." However, Suvannavejh remarked that Coronado has not provided sufficient evidence to support claims the therapy could potentially treat severe Crohn's disease. The drugmaker said detailed results will be reported at upcoming medical and scientific meetings.
Meanwhile, the company said results from a second interim analysis of Dr. Falk Pharma's TRUST-II study, which is testing the safety and efficacy of three dosages of TSO in patients with active Crohn’s disease, are anticipated in the fourth quarter.
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