AbbVie's $8.7 Billion Bet on Emraclidine Fails as Phase 2 Schizophrenia Trials Miss Primary Endpoint

Nov 12, 2024 11:32 CST Updated 11:32

AbbVie

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On November 11, AbbVie announced the $9 billion acquisition of Cerevel's core drugs.EMPOWER Failed in Two Phase II Clinical Trials, EMPOWER-1 and EMPOWER-2, Targeting Patients with Schizophrenia.

EMraclidine as a once-daily oral monotherapy for the treatment of acute exacerbation of psychotic symptoms in adult patients with schizophrenia did not meet its primary endpoint, namelyTotal score of the Positive and Negative Syndrome Scale (PANSS) at Week 6 compared with the placebo group。

In the EMPOWER-1 study, patients were randomly assigned 1:1 to two dose levels (10mg/30mg) and placebo. The EMPOWER-2 study randomized patients in the same way but observed 15mg and 30mg. Enrolled patients took emraclidine once daily, with PANSS effects measured over 6 weeks. In EMPOWER-1, the placebo group showed a PANSS reduction of 13.5 points, while the 10mg and 30mg treatment groups decreased by 14.7 points and 16.5 points, respectively; in EMPOWER-2, the placebo group showed a reduction of 16.1 percentage points, while the 15mg and 30mg treatment groups decreased by 18.5 percentage points and 14.2 percentage points, respectively.

Emraclidine was well-tolerated, with a safety profile consistent with that observed in the Phase 1b trial.

“Although we are disappointed with the results, we will continue to analyze the data to determine the next steps."Roopal Thakkar, M.D., Executive Vice President of Research and Development and Chief Scientific Officer of AbbVie, said."

The news came,AbbVie's stock price fell more than 12%. Meanwhile, Bristol Myers Squibb's stock price rose about 12% due to the failure of Emraclidine., which is the highest single-day increase since March 2006.

Emraclidine was obtained by AbbVie through the $8.7 billion acquisition of neurology biotech company Cerevel Therapeutics., intensifying its layout in the neuroscience field. Emraclidine competes with BMS/Karuna's newly approved Cobenfy (KarXT).

Emraclidine is a positive allosteric modulator (PAM) of the muscarinic M4 receptor., it is considered a potential next-generation antipsychotic drug. It reduces dopamine signaling by selectively modulating the M4 receptor without the need to block the D2 receptor, which may reduce the side effects of existing antipsychotic drugs.

Recently,FDA Approves BMS's First-in-Class Drug KarXT (Now Named Cobenfy) for Oral Treatment of Adult SchizophreniaBMS demonstrated the efficacy of Cobenfy through data from three registration trials, which showed that the drug is beneficial in treating schizophrenia on the Positive and Negative Syndrome Scale.

Cobenfy is an M1/M4 muscarinic receptor agonist, while emraclidine is an M4 muscarinic receptor agonist.。Therefore, companies solely targeting M4 for schizophrenia drugs may encounter issues, including Neumora.TheSchizophrenia MedicationsNMRA-266And Neurocrine Biosciencesluvadaxistat。

April 2024,Neumora's Schizophrenia Treatment Drug NMRA-266 Clinical Trial Halted by FDA Due to Preclinical Data Showing the Drug Caused Seizures in RabbitsNMRA-266 is a highly selective positive allosteric modulator of the M4 muscarinic receptor;In September 2024, Neurocrine's schizophrenia drug luvadaxistatTwoSubclinical Phase II Failure, and ultimately decided to halt the development of luvadaxistat (NBI-1065844).

In summary, the failure of Emraclidine also illustrates that the mechanisms behind this drug and the broader new neuroscience programs are not as easy to succeed as investors had imagined.

In the case where Cobenfy has already been approved for marketing,The failure of Emraclidine's clinical trial is a significant blow to AbbVie and may also alter the competitive landscape of the schizophrenia treatment market.ForBMSFor AbbVie, it is equivalent to the market expectation eliminating Cobenfy's biggest competitor and may push the peak sales forecast to a consensus expectation of $4 billion.

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