Cerecor drops on Phase 2 failure, remains optimistic
- The latest topline results from Cerecor's Phase 2 study of CERC-301 in major depressive disorder have proved disappointing – the oral, NR2B-specific, NMDA receptor antagonist has not met its primary endpoint for improvement on the Bech-6 subset of the Hamilton Depression Scale (an average difference from placebo of +1.45 for 12 mg and -0.04 for 20 mg).
- The company reports signals for the 20 mg dose at day two for two secondary endpoints, suggesting a potentially clinically-meaningful, though not statistically significant, improvement. There was no improvement for other secondary endpoints.
- Further analysis of the results is ongoing, but this clinical setback has led to the Baltimore company's share prices tumbling by more than half. Cerecor shares closed above $5 per share on Nov. 28 in anticipation of the results, but dropped down to $2 after the data announcement.
Despite the failure of the Phase 2 trial of CERC-301, Cerecor seemed optimistic that it can still find a path forward for the drug.
"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 Uli Hacksell, president and CEO of Cerecor. "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."
Depression is disabling and widespread. Major depressive disorder affects around 7% of the U.S. population, and takes people out of work, school and social activities. There are many drugs available, but for a certain population, these just do not work. The NMDA pathway has been explored as an alternative approach, supported by the findings that the anesthetic ketamine can have a rapid and dramatic effect in hard to treat depression.
Cerecor also has a selective kappa opioid receptor (KOR) antagonist, CERC-501, in Phase 2 for mood and anxiety disorders, and CERC-406, a selective, brain penetrant COMT inhibitor in preclinical evaluation for residual cognitive impairment symptoms of major depressive disorder (MDD).
Allergan is assessing rapastinel, acquired when it bought up Naurex, in Phase 3 trials in major depressive disorder. Rapastinel, a partial agonist of NMDA, has breakthrough therapy designation and fast track classification in the U.S.
- Cerecor Statement
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