(MENAFN- ProactiveInvestors - N.America) Baltimore-based biotech Cerecor saw its shares go up in smoke today after it said a midstage clinical trial for a nicotine withdrawal treatment failed to meet its primary objective.
Despite the setback, the company said it will continue to develop the CERC-501 treatment for Major Depressive Disorder.
Ronald Marcus, the Chief Medical Officer and Head of Regulatory Affairs for Cerecor, said: "While CERC-501 did not demonstrate efficacy in this trial, we are encouraged by the drug's overall safety profile.'
The neuroscience firm's shares were indicated opening over 40% lower on Wall Street, having closed trading on Friday at $1.75 each. The stock is already down 47.8% in the year-to-date,
The study was a randomised, double-blind, placebo-controlled, crossover study of 71 subjects who are heavy cigarette smokers and currently not seeking treatment for tobacco use disorder.
The trial did not achieve its objectives for an improvement compared to a placebo on symptoms of tobacco withdrawal and smoking behaviors, as measured by an improvement in time to start smoking and the number of cigarettes smoked following abstinence.
However, it said CERC-501 was generally well-tolerated with no serious adverse events reported and no discontinuations due to adverse events.
Cerecor added that it intends to present additional data from the trial at scientific meetings in 2017.
Dr. Uli Hacksell, Cerecor's President and Chief Executive Officer, said: "We will now turn our focus to preparing CERC-501 for a Phase 2/3 clinical trial as an adjunctive treatment of MDD in patients with an inadequate response to standard antidepressant therapies.
'We hope to initiate this trial in the second half of 2017."
Currently, three externally-funded clinical trials are being conducted to evaluate the use of CERC-501 in treating depressive symptoms, stress-related smoking relapse and cocaine addiction.
The National Institute on Alcohol Abuse and Alcoholism at the National Institutes of Health has given Cerecor a $1.0mln grant to progress the development of CERC-501 for the treatment of Alcohol Use Disorder.
In addition to CERC-501, Cerecor has three other novel compounds in development - CERC-301, CERC-611 and CERC-406 – linked to Major Depressive Disorders and epilepsy.
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