Results

Little Neurotrope makes some big claims on another failed Alzheimer’s study, but shares collapse

Daniel Alkon, Neurotrope

A low profile, small biotech named Neurotrope $NTRP teased out a pocket of data from a small Phase II Alzheimer’s study which its investigators heralded as ‘positive.’

So why did its stock just plunge 53%?

Because the study failed, like virtually everything else that’s happened in Alzheimer’s R&D over the last 15 years.

To get to its “positive” nugget of data, investigators narrowed the field to a subgroup of moderate to severe patients who completed all six low doses of Bryostatin-1, designed to boost synapses in the brain that deteriorate rapidly in the disease, wreaking havoc in the brain.

It wasn’t statistically significant, but the subgroup responded better than the placebo arm on the Severe Impairment Battery test used to evaluate cognition. After 12 weeks their score went up 1.5 points while the placebo arm experienced a 1.1 point decrease, a 2.6 point gap favoring the drug.

The number of “completers,” though, was so small, the improvement so low and the time the drug was tested was so short that the data nevertheless indicated that the gap — such as it was — could be the result of chance.

That’s a failed study. But Neurotrope believes that hint of efficacy needs to be explored in a larger trial — not the first time that’s happened in Alzheimer’s.

Investors weren’t in a generous mood, though. Big pharma has done a battery of tests of various new drugs. Roivant’s Axovant is one of the furthest along in the clinic, looking for data before the end of this year on another drug aimed at preserving cognition which GSK had tried, and failed, with. And Biogen has one of the most closely watched drugs — aducanumab — that looks to modify the course of the disease, which is now in late-stage trials.

Billions have been spent on failed trials in Alzheimer’s. Neurotrope just added a small contribution of their own, adding some big spin in the process.

“These results, which show improvement in patients with moderate to severe Alzheimer’s disease, the population that is generally recognized as the most difficult to treat, provide exciting evidence of a new therapeutic approach potentially could rejuvenate synaptic networks in the brain. Improvements across the range of important manifestations of the underlying neurodegenerative disease, as shown in this Phase II study, could potentially represent a shift in the paradigm to treat Alzheimer’s disease,” said Daniel Alkon, President and Chief Scientific Officer of Neurotrope.


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RAPS Regulatory Convergence 2017