Drug Development

Alkermes claims a success in PhIII schizophrenia head-to-head, but where’s the benefit for patients?

Richard Pops

Alkermes $ALKS has one shot at making ALKS-3831 a standout in the schizophrenia field. For years now, investigators expected to be able to show that the drug performs pretty much the same as the generic olanzapine in terms of efficacy, but significantly better in terms of preventing the weight gain — and all the risks that come with it — that afflicts patients on the old drug.

But in the first of two Phase III readouts on Thursday evening, investigators were only able to point to a similar efficacy with olanzapine without the benefit on weight gain.

Elliot Ehrich

Alkermes CEO Richard Pops and R&D chief Elliot Ehrich were sticking with the top line and heralded the data as a success. But in a wrap on side effects the company also noted that weight gain was similar for both drugs.

The stock dropped 5% as the data hit Thursday evening, carving out more than a billion dollars in market cap.

“Those rates were similar,” noted Ehrich during the Q&A with analysts Thursday evening.

The two execs, though, insisted that the 4-week study was simply too short to expect a separation on weight gain. That key question, they say, will have to wait for a 6-month study where patients will have a chance to balance the scale in favor of the Alkermes drug.

Based on its earlier work, says Pops, it clearly takes time – three to six months — for the weight gain advantage to demonstrate itself.

“Many physicians recognize the powerful efficacy profile of olanzapine, but are hesitant to prescribe it given the severe weight gain and metabolic side effects commonly associated with its use,” said Christoph Correll, M.D., professor of Psychiatry and Molecular Medicine at Hofstra Northwell School of Medicine. “A new antipsychotic with robust efficacy and a favorable weight and metabolic profile compared to olanzapine would be a welcome addition to the schizophrenia treatment landscape. This study confirms a key element of this profile, with a clear demonstration of efficacy in a large, well-conducted clinical trial.”


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