Xanomeline

EMERGENT trials enrolled adults with schizophrenia, excluding those with treatment resistance or recent non-schizophrenia diagnoses. The 5-week, double-blind, placebo-controlled trials evaluated xanomeline/trospium in the U.S. and Ukraine. Primary endpoint was change in PANSS total score at week 5, with secondary outcomes including PANSS subscale scores and CGI-S score. Statistical analysis used MMRM models, and responder analyses were based on PANSS and CGI-S criteria.

Cobenfy (xanomeline and trospium chloride) showed sustained efficacy in schizophrenia patients over 52 weeks, with significant symptom and quality of life improvements and minimal adverse effects. The drug maintained its safety and tolerability profile, with no weight gain, movement disorders, or metabolic changes observed. Results from EMERGENT-4 and EMERGENT-5 trials indicate Cobenfy's long-term effectiveness and safety in treating schizophrenia.

A new schizophrenia drug, Cobenfy, showed improvement in patients with few side effects, but high dropout rates typical in such studies. Cobenfy, approved in September, works differently in the brain and includes trospium to mitigate side effects like nausea. Despite the high dropout rates, some patients experienced meaningful symptom improvement, and the drug led to weight loss. The cost of Cobenfy is significantly higher than generic alternatives, raising concerns about insurance coverage.

Zai Lab's Phase III trial of KarXT (xanomeline and trospium chloride) in China showed significant reduction in schizophrenia symptoms, with a 9.2-point decrease in PANSS total score compared to placebo at week five. The trial involved 202 hospitalised patients and met primary and secondary endpoints, indicating KarXT's potential as a new treatment option. Zai Lab plans to submit an NDA to China's NMPA by early 2025.

Zai Lab reports positive Phase 3 trial results for KarXT in China, showing a 9.2-point reduction in PANSS Total score vs. placebo at Week 5 (p=0.0014), meeting all secondary endpoints. KarXT has a tolerable safety profile, prompting Zai Lab to plan an NDA submission to China’s NMPA in early 2025.

Bristol Myers Squibb presents COBENFY data at Psych Congress, highlighting efficacy, safety, and patient outcomes in schizophrenia treatment.

FDA approved Cobenfy, a novel schizophrenia drug combining xanomeline and trospium chloride, targeting cholinergic receptors instead of dopamine. Schizophrenia, affecting 1 in 100, has serious consequences including social isolation and a 13-15 year reduced life expectancy. Cobenfy aims to avoid older drugs' side-effects, though it has its own side-effects like nausea and dizziness, priced at $1,850 a month.

Seaport Therapeutics closed a $225 million Series B financing round, led by General Atlantic, to advance its neuropsychiatric medicines and Glyph™ technology platform. The Glyph platform enhances oral drug administration via the lymphatic system, addressing issues like low bioavailability and side effects. The funding will support clinical trials for candidates like SPT-300 for major depressive disorder and SPT-320 for generalized anxiety disorder.

The FDA approved Cobenfy (xanomeline and trospium chloride, or KarXT) on Sept. 26, the first antipsychotic drug targeting cholinergic receptors for schizophrenia in adults, not dopamine receptors. Cobenfy showed fewer extrapyramidal symptoms, metabolic adverse effects, and sedation compared to other antipsychotics. John H. Krystal, MD, from Yale University, expressed excitement about the new treatment strategy. Bristol-Myers Squibb Company received the approval, with Ken Kramer from Karuna Therapeutics highlighting the significance of a new treatment option for schizophrenia. BMS is also exploring KarXT for psychosis in other diseases like Alzheimer’s.

Terran Biosciences, led by CEO Sam Clark, is leveraging the FDA's 505(b)(2) pathway to expedite the development of TerXT, a new treatment for schizophrenia. By referencing data from Bristol Myers Squibb's Cobenfy, Terran aims to create a once-daily oral dose and a long-acting injectable version of TerXT, addressing Cobenfy's limitations. This approach, which includes the use of prodrugs, aims to provide more affordable and accessible treatment options for patients.