Results, Setbacks

Fresh enthusiasm for Cerecor sours as lead drug flops in PhII depression study, shares crater

Uli Hacksell, Cerecor

Uli Hacksell, Cerecor

A few weeks ago, investors embraced shares of Cerecor in the big surge that swept up Alkermes’ stock following its clinical success for an anti-depression drug that bore some striking resemblances to one of the microcap’s experimental depression treatments, CERC-501, in-licensed for a small upfront from Eli Lilly.

But that comforting comparison gave way to a disappointing reality Tuesday evening as Cerecor reported that its lead depression drug in the pipeline — CERC-301 — flopped in a mid-stage study.

Company execs touted evidence of a clinically meaningful response and vowed to go forward with the failed drug. But this time, instead of a big gain, the microcap’s shares $CERC cratered, dropping 47% in after-market trading.

CERC-301 targets the NMDA receptor, one of a number of drugs that is hoping to follow up on the radical impact of ketamine, a horse tranquilizer and NMDA drug known to have a heavy impact on major depression in record time. It’s also a party drug as Special K, known for certain hallucinatory side effects the experimental meds hope to avoid.

Now it joins the long, long list of depression drugs to fail to live up to its billing in the clinic.

Baltimore-based Cerecor preferred to zero in on certain trends in the data that indicated it was having an effect on day two of treatment. But it failed the primary endpoint, ranking patients’ response on day two and day four.

It was a different story a month ago, when Alkermes $ALKS whistled up an instant spike for their share price on positive Phase III data for ALK-5461. Shares of microcap Cerecor also ignited, bouncing up because its mid-stage drug, CERC-501, has the same mechanism as the Alkermes candidate. Just like ‘5461, CERC-501 is a kappa opioid receptor antagonist. And while no two drugs are necessarily exactly alike, the resemblance was good enough for investors looking for other benefactors of this data.

Today investigators noted:

In this SPCD designed study, the mean improvement from baseline on the Bech-6 scale averaged over Days 2 and 4 post treatment for Period 1 was 3.82 for placebo, 2.50 for the 12 mg dose and 4.11 for the 20 mg dose, and for Period 2 was 2.86 for placebo, 1.64 for the 12mg dose and 3.38 for the 20 mg dose. The weighted average for the difference in placebo and drug improvement (placebo minus drug) was +1.45 and -0.04 for 12 mg and 20 mg CERC-301, respectively.

“Based on this well conducted and controlled clinical trial, we continue to believe that adjunctive CERC-301 may have the potential to reduce depressive symptoms very rapidly with the added patient convenience of oral dosing,” said Cerecor CEO Uli Hacksell, in a statement. “We intend to more fully assess the results from this trial as we continue to receive the remaining data sets over the coming weeks and will announce planned next steps for CERC-301 at a later time.”


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RAPS Regulatory Convergence 2017