Cerevel investors' blood pressure relieved as safety data de-risks schizophrenia drug

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来源: FierceBiotech

Cerevel’s phase 2 program for emraclidine continues after the blood pressure results, with a readout focused on efficacy expected in the first half of 2024.

Cerevel Therapeutics investors themselves had some raised blood pressure as they anxiously awaited phase 1 safety results for the biotech’s schizophrenia drug. With the news that it does not, in fact, raise blood pressure, an analyst from Mizuho Securities is hoping the rest of the Pfizer apprentice’s pipeline can shine.

Emraclidine was previously found to reduce symptoms of schizophrenia in a phase 1b clinical trial, setting up a move to phase 2 and a stock price boom for the biotech. But questions remained about safety, specifically, whether the therapy raised blood pressure in patients who require chronic dosing.

Not only does emraclidine not raise blood pressure, but patients in a phase 1 trial actually had a reduction in 24-hour ambulatory systolic blood pressure at week eight, according to a Monday press release. This met the main goal of the early-stage safety trial, which was probing the results of ambulatory blood pressure monitoring (ABPM) in patients taking emraclidine.

Cerevel’s shares closed up 20% on Monday, which Mizuho's Graig Suvannavejh, Ph.D., attributed to the de-risking of the asset.

Mizuho was not surprised by the news but noted that investors were anxious for the readout. The fear of this side effect came from the earlier phase 1b/2 study where a rise in blood pressure was flagged as a possibility with long-term treatment. But the cardiovascular side effects were not symptomatic in those who experienced the side effect in the other trial, leading to Mizuho’s nonchalance about the possibility.

“From a bigger picture perspective, we believe the ABPM data are important not just in terms of investor attention on (in our view, obsession with) emraclidine itself, but also in terms of investor attention on [Cerevel] more broadly,” Mizuho wrote in a Monday evening note.

But that doesn’t mean Mizuho is uninterested; the firm is confident in emraclidine, putting its success at 70% probability. The firm also noted that the reduction in blood pressure was minor and not a cause for concern either.

“We're pleased to see the positive phase 1 ABPM data for emraclidine, but as we had already assumed there to be no [cardiovascular] issue in the first place, it does little to change our already bullish view on emraclidine,” the note said.

Cerevel’s phase 2 program for emraclidine continues, with a readout focused on efficacy expected in the first half of 2024. The biotech is hoping to position the therapy as a new standard of care that does not come with debilitating side effects due to blocking dopamine receptors. Side effects include tremors, uncontrollable muscle contractions, tics and more.

With the blood pressure study out of the way, Mizuho is hoping focus can shift to the rest of Cerevel’s pipeline, which includes the phase 3 Parkinson’s disease med tavapadon, phase 2 dementia-related apathy treatment CVL-871 and darigabat for focal epilepsy.

Mizuho noted that timelines for the three pipeline meds have been pushed out a bit recently, with updates for the first two expected in the first quarter while investors will have to wait until mid-2023 for an update on darigabat.

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