Results

Neuralstem’s lead drug crumbles in PhII, adding to a litany of failures for depression drugs and blasting shares

Rich Daly

Neuralstem $CUR says its Phase II study of the experimental depression drug NSI-189 — its lead therapy in the pipeline — failed to hit the primary endpoint, adding another flop to a field that has been stigmatized by regular failures and eviscerating the biotech’s stock.

The drug did not hit a statistically significant goal for reducing symptoms of depression based on the well known MADRS test. A secondary endpoint based on the Hamilton Depression Rating Scale was also missed, though the company noted it was “directionally positive.” A second secondary for a patient questionnaire did achieve statistical significance, though barely, with a p-value of 0.044.

Shares plunged 58% for the small biotech, obliterating the $67 million market cap it started the day with.

Maurizio Fava at Mass General, the principle investigator, said he was encouraged by the data. He noted: “NSI-189 is a novel small molecule that has shown a potential signal of efficacy in this trial. We are encouraged by its emerging clinical profile, and continuing the clinical evaluation of NSI-189 to pursue its full potential is warranted.”

Depression was once a big field in drug R&D, but a long sequence of failures, often driven by a high placebo response, has pushed a number of prominent players like AstraZeneca out of the field.

CEO Rich Daly says it’s now time to analyze the data and see how it wants to proceed. Failed Phase II depression drugs, though, don’t have a great track record.


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RAPS Regulatory Convergence 2017