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Bristol-Myers Squibb’s long-awaited schizophrenia treatment KarXT is nearing its launch. September FDA decision datesand with a market size likely to exceed $100 billion, competition is already heating up. $7 billion by 2028.
KarXT, a muscarinic agonist, First new class Decades of progress in schizophrenia treatments have $10 billion The odds of a sale are high, but competitors are lurking in the bushes nearby, ready to launch attacks and chip away at your long-term prospects.
One candidate drug is AbbVie’s emracidine, which also targets muscarinic receptors, Dawn Carlson, PhD, vice president of neuroscience development at AbbVie, said in an email.
Early promise
People with schizophrenia experience a wide range of symptoms, from hallucinations and delusions to cognitive impairment and social withdrawal.
In early trials, Cal XTEmracidine, AbbVie Acquired from Cerevel Therapeutics in Multi-billion dollar dealIt effectively suppresses various symptoms of schizophrenia without the side effects and drawbacks of conventional antipsychotic drugs. Nearly three-quarters of patients Stop treatment.
But experts say once-daily versus twice-daily treatments, and more gut-friendly regimens, are better. Giving Emracidine an Edge Bristol-Myers Squibb Acquired through $14 billion acquisition Karuna Therapeutics.
Emracidine is designed to reduce the excess dopamine signaling that causes schizophrenia symptoms, but doesn’t block the entire receptor, Carlson said. The drug blocks a specific receptor, called M4, across the board, which could help patients deal with symptoms without the side effects that come with less-precise treatments.
a Phase 1b study They found that patients who received emracidine for six weeks experienced statistically significant improvements in standardized measures of symptom severity, without any side effects such as weight gain, restlessness or movement disorders.
“By selectively targeting the M4 receptor, emracidine caused rare gastrointestinal side effects, the incidence of which was similar to that of placebo,” Carlson said.
AbbVie is testing the drug in two mid-stage studies that could lead to approval and expects to share top-line data later this year.
Asset collection
Carlson said the Cerebelle acquisition, which closed this month, gave AbbVie not only emracidine but also several preclinical and clinical-stage drugs that fit into the pharmaceutical giant’s existing portfolio.
“Cerevelle has multiple programs in its pipeline targeting psychiatric and neurological diseases where there remains significant unmet patient need, including schizophrenia, Parkinson’s disease and mood disorders,” she said.
In addition to schizophrenia, emracidine may also have applications in dementia-associated psychosis such as Alzheimer’s disease and Parkinson’s disease.
Emracidine is not the only schizophrenia drug currently in development, and several others are in the works, many of which target the same dopamine and serotonin receptors as traditional antipsychotics, but others, such as KarXT and emracidine, are trying new approaches.
Neurocrine Biosciences is also conducting Phase 2 trials of a muscarinic agonist in collaboration with Nexera Pharma. The company also has rubadaxistat, a selective d-amino acid oxidase inhibitor, as a candidate for mid-stage schizophrenia. Boehringer Ingelheim is conducting Phase 3 trials with iclepertine, a selective glycine transporter 1 inhibitor. AbbVie is uncertain about how emracidine will fare against these investigational drugs.
“At this time, we have not conducted head-to-head studies directly comparing emracidine with other potential treatments,” Carlson said.
Teran Biosciences is also trying to compete with KarXT with a prodrug that becomes active once inside the body. This treatment could allow the company to bring a competing product to market after Bristol-Myers Squibb’s five-year exclusivity period ends. Additionally, Teran is considering a twice-daily dosing schedule for KarXT, which would allow it to be administered in a 2-day dose schedule. Once-daily tablet and the long-acting injectable TerXT LAI.
A more competitive market may be a challenge for pharmaceutical companies, but it will be welcomed by schizophrenia patients seeking better treatment options. Top 15 It is the leading cause of disability worldwide, yet affects only 1% of the population.
“There remains a large unmet need for additional therapies with different mechanisms of action in the treatment of schizophrenia,” Carlson said.
