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Takeda's AI-crafted Psoriasis Pill Tops Bristol Myers' Sotyktu in Head-to-head Trial
June 11 (Reuters) - Japan's Takeda Pharmaceutical said on Thursday its experimental once-daily psoriasis pill, developed with the help of AI, outperformed Bristol Myers Squibb's approved drug Sotyktu in a late-stage head-to-head study. Here are some details: * The Japanese drugmaker said the drug, zasocitinib, met the main goal of a late-stage trial in adults with moderate-to-severe plaque psoriasis, achieving greater skin clearance than Sotyktu after 16 weeks of treatment. * Plaque psoriasis is a chronic immune-mediated skin disease that causes red, scaly, inflamed patches on the skin. * Zasocitinib was developed using artificial intelligence, reflecting a growing trend in the pharmaceutical industry to use AI to speed drug development, shorten clinical trial timelines and reduce animal testing. * Takeda said zasocitinib achieved complete skin clearance in 35% of patients after 16 weeks, more than 2.5 times the rate seen with Sotyktu. * The company also said zasocitinib's safety profile was consistent with earlier studies and no new safety issues were identified. * Takeda's daily pill offers a convenient option to treat plaque psoriasis, alongside Bristol Myers' Sotyktu and Amgen's Otezla, in a market largely dominated by injectables. * The drugmaker is counting on zasocitinib as a potential blockbuster to help offset a revenue gap from the looming patent cliff for its inflammatory bowel disease drug Entyvio, which is expected to lose key patents by the end of the decade. * Takeda said last year that it expects zasocitinib, if approved, to generate peak annual sales in the range of $3 billion to $6 billion. * The drugmaker had acquired zasocitinib from Nimbus Therapeutics in 2022 in a deal valued at up to $6 billion. * Takeda said it will present detailed data at upcoming medical meetings and remains on track to begin seeking FDA approval for zasocitinib to treat plaque psoriasis this fiscal year. (Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Diti Pujara)
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Takeda AI-Drug Shows Superior Skin Clearance Against Bristol-Myers' Med - Takeda Pharmaceutical Co (NYSE:
In the LATITUDE Atlas head-to-head study, zasocitinib demonstrated statistical superiority over deucravacitinib for the primary endpoint, Psoriasis Area and Severity Index (PASI) 100 response rate at week 16. The study also demonstrated statistical superiority over deucravacitinib for all key secondary endpoints, including PASI 90 response and Static Physician's Global Assessment (sPGA) 0 at week 16. Zasocitinib was generally well tolerated with a consistent safety and tolerability profile and no new safety signals identified. Investigators Highlight Skin Clearance Results AI-Developed Drug Targets Multi-Billion-Dollar Opportunity Zasocitinib was developed using artificial intelligence, highlighting the pharmaceutical industry's increasing use of AI to accelerate drug development, streamline clinical trials, and reduce reliance on animal testing, Reuters reported. Takeda said last year that, if approved, zasocitinib could achieve peak annual sales of $3 billion to $6 billion. Next Steps For Zasocitinib Program The company is on track to submit a New Drug Application for plaque psoriasis with the U.S. Food and Drug Administration and other regulatory authorities starting this fiscal year. TAK Price Action: Takeda Pharmaceutical Co shares were up 0.61% at $15.77 at the time of publication on Thursday, according to Benzinga Pro data. Photo by Veroniksha via Shutterstock Market News and Data brought to you by Benzinga APIs To add Benzinga News as your preferred source on Google, click here.
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Takeda Pharmaceutical announced its AI-crafted experimental psoriasis drug zasocitinib achieved superior skin clearance compared to Bristol Myers' approved Sotyktu in a late-stage study. The once-daily pill delivered complete skin clearance in 35% of patients after 16 weeks, more than 2.5 times Sotyktu's rate, positioning it as a potential blockbuster with projected peak annual sales of $3-6 billion.
Takeda Pharmaceutical reported breakthrough results from its LATITUDE Atlas study, where zasocitinib, an experimental psoriasis drug developed using artificial intelligence, demonstrated statistical superiority over Bristol Myers Squibb's approved medication Sotyktu (deucravacitinib) in a head-to-head trial
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. The once-daily pill achieved complete skin clearance in 35% of patients with moderate-to-severe plaque psoriasis after 16 weeks of treatment, representing more than 2.5 times the rate observed with Sotyktu1
. This marks a significant milestone in AI drug development, showcasing how machine learning can accelerate drug discovery and deliver clinically meaningful outcomes for patients suffering from chronic immune-mediated skin diseases.
Source: Benzinga
The late-stage clinical trial met its primary endpoint, with zasocitinib achieving superior Psoriasis Area and Severity Index (PASI) 100 response rates at week 16 compared to deucravacitinib
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. Beyond the primary measure, the study demonstrated statistical superiority across all key secondary endpoints, including PASI 90 response and Static Physician's Global Assessment (sPGA) 0 at week 162
. Takeda Pharmaceutical emphasized that zasocitinib was generally well tolerated, with a consistent safety and tolerability profile matching earlier studies and no new safety signals identified1
. The superior skin clearance results position zasocitinib as a potentially best-in-class oral treatment option in a market currently dominated by injectable therapies.Zasocitinib reflects the pharmaceutical industry's growing reliance on artificial intelligence to speed drug development, shorten clinical trial timelines, and reduce animal testing
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. Takeda acquired the compound from Nimbus Therapeutics in 2022 through a deal valued at up to $6 billion, underscoring the company's confidence in its commercial potential1
. The drugmaker projects that zasocitinib, if approved, could generate peak annual sales ranging from $3 billion to $6 billion1
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. This revenue is critical for Takeda as it seeks to offset an anticipated gap from the looming patent cliff for Entyvio, its inflammatory bowel disease drug expected to lose key patents by the end of the decade1
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Takeda remains on track to submit a New Drug Application for plaque psoriasis treatment with the U.S. Food and Drug Administration and other regulatory authorities starting this fiscal year
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. The company plans to present detailed data from the LATITUDE Atlas study at upcoming medical meetings1
. If FDA approval is granted, zasocitinib will join Bristol Myers' Sotyktu and Amgen's Otezla as convenient oral alternatives in a therapeutic landscape largely dominated by injectable biologics. The drug's superior efficacy profile and once-daily dosing could position it as a preferred first-line oral therapy, potentially reshaping treatment paradigms for moderate-to-severe plaque psoriasis and demonstrating how AI-driven drug discovery can translate into meaningful clinical advantages for patients.Summarized by
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