Shares of H. Lundbeck A/S plunged more than 25 percent after the company announced Thursday that its Phase III treatment for treatment-resistant schizophrenia failed to differentiate itself against conventional therapies.
Shares of H. Lundbeck A/S plunged more than 25 percent after the company announced Thursday that its Phase III treatment for treatment-resistant schizophrenia failed to differentiate itself against conventional therapies.
The company was studying Lu AF35700, a novel, once-per-day oral antipsychotic drug candidate as a potential therapy for schizophrenia patients who have been difficult to treat. However, the company noted that the Phase III drug candidate did not meet the primary endpoint of statistical superiority vs conventional therapy. Lundbeck was evaluating its drug candidate against two common medications for treatment-resistant schizophrenia, risperidone or olanzapine.
That announcement caused share prices to tumble. The stock fell from $60.85 to a close of $46.16. That wiped out about $4 billion in market value for the Denmark-based company. It was the worst selloff in company history, Bloomberg reported.
Anders Gersel Pedersen, head of researcher and development at Lundbeck, said treatment-resistant schizophrenia is the “highest burden of disease within schizophrenia” for patients and society. Treatment-resistant schizophrenia is associated with poor prognosis and functional outcomes. Individuals with treatment-resistant schizophrenia are at increased risk of hospitalization, unemployment, homelessness, aggression, imprisonment, substance abuse, violent victimization, and suicide, according to Lundbeck. With Lu AF35700, the company had hoped to show that it was a superior treatment to medications already on the market, he said. Things looked hopeful for the drug when the U.S. Food and Drug Administration granted Lu AF35700 Fast Track designation three years ago.
“This is a setback for patients with schizophrenia, but we will continue to advance our pipeline of innovative therapies to meet the needs of patients suffering from psychiatric and neurological diseases,” Pederson said.
Lu AF35700, an antagonist at dopaminergic, serotonergic, and α adrenergic receptors, was being studied in the Phase III DAYBREAK 1 trial, a double-blind randomized and active-controlled study evaluating the efficacy and safety of the medication. Over a 10 week period, nearly 1,000 patients with treatment-resistant schizophrenia were dosed with either the Lundbeck drug or control. Lundbeck said the target treatment-resistant schizophrenia population was patients who met the DSM-5 criteria for schizophrenia who experienced ongoing psychotic symptomatology and demonstrated a lack of satisfactory clinical improvement to at least two different antipsychotics given at an adequate dose and duration.
While the drug did not show statistical superiority against the two conventional treatments, Lundbeck noted that Lu AF35700 demonstrated “good anti-psychotic effects” during the study. The company said it will continue to analyze the data. Lu AF35700 was safe and generally well-tolerated at 10 mg and 20 mg doses during the study with no unexpected adverse events reported, Lundbeck said.
