Artificial Intelligence
BioXcel Therapeutics Announces Initiation of Phase 2 PLACIDITY Trial of BXCL501 for the Treatment of Delirium Related Agitation
NEW HAVEN, Conn., Feb. 25, 2021 (GLOBE NEWSWIRE) — BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced the initiation of the Phase 2 PLACIDITY trial of BXCL501, the Company’s investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine (“Dex”), for the treatment of delirium related agitation.
“The initiation of PLACIDITY marks an important milestone in our efforts to showcase BXCL501’s ability to calm patients struggling with delirium related agitation, our fifth potential indication for this candidate,” commented Vimal Mehta, Chief Executive Officer of BioXcel. “Treating agitation associated with delirium remains a challenge for healthcare workers and patients as there are no FDA-approved therapies and off-label treatments are suboptimal, resulting in serious medical complications and extended hospital stays. We believe BXCL501, if approved, would be a welcomed therapy option for the approximately 4 million U.S. patients suffering from delirium related agitation annually, and we look forward to reporting topline results in the first quarter of 2022. Moreover, since delirium occurs across treatment settings within a hospital, this potential indication would be synergistic with the commercial infrastructure we are currently building to support our first New Drug Application.”
The PLACIDITY trial is a multicenter, randomized, double-blind, placebo-controlled, ascending dose-finding, adaptive Phase 2 study designed to evaluate the safety, efficacy, and pharmacokinetics of BXCL501 in intensive care unit adult patients experiencing delirium related agitation, including COVID-19 patients. Approximately 20 patients will be randomized into each sequential ascending dose cohort of BXCL501 (starting doses of 120 ug, 180 ug, 240 ug, or 300 ug), or matching placebos to determine an optimal starting dose that could effectively and safely reduce agitation. Elderly delirium patients (65 years or older) in these cohorts will receive half the dose. The primary endpoint is the reduction in agitation measured by at least a 2-point drop in the Richmond Agitation Sedation Scale (“RASS”) at two hours post BXCL501 administration. The secondary endpoint is the earliest time at which a 2-point drop is seen in RASS after BXCL501 administration. An exploratory endpoint of this trial will be to determine the overall clinical improvement after drug administration using the Clinical Global Impression – Improvement Scale (“CGI-I”).
About Delirium Related Agitation:
Delirium is a serious condition that occurs in a variety of hospital settings, including frequently in the intensive care unit. This condition may be caused by numerous underlying pathologic processes and disease states. Delirium is known to cause public health burden due to extended hospital stays, medical complications, increased financial costs and increased mortality. Delirium related agitation occurs in the majority of patients with this condition. Agitated patients with delirium are unable to calm themselves, rest or sleep and often self-extubate, remove catheters and IV lines thus complicating overall patient care. With no FDA-approved treatments for this condition, current guidelines recommend sedative medications to maintain a light level of sedation in adult patients, which is frequently not achieved with commonly used therapies. A therapy that quickly and effectively reduces agitation, without causing excessive sedation, is needed to speed up recovery time and improve patient outcomes.
About the Richmond Agitation Sedation Scale (“RASS”)
The most commonly used and recommended instrument for agitation assessment in the ICU is the Richmond Agitation-Sedation Scale (“RASS”). The Richmond Agitation–Sedation Scale was developed in a collaborative effort with practitioners representing critical care physicians, nurses, and pharmacists and its validation and reliability is well documented. RASS is a 10-point scale that ranges from +4 to -5. There are four point levels to assess agitation (+4 to +1), a single point level to denote a calm and alert state (0), and five point levels to assess sedation (-1 to -5). On one end of the RASS score, +4 represents a very combative, violent patient, who is dangerous to the staff. On the other end, -5 represents a patient who is unarousable, with no response to voice or physical stimulation.
About BXCL501
BXCL501 is an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine, a selective alpha-2a receptor agonist for the treatment of agitation and opioid withdrawal symptoms. BioXcel believes that BXCL501 directly targets a causal agitation mechanism, and the Company has observed anti-agitation results in multiple clinical studies across several neuropsychiatric disorders. BXCL501 has been granted Fast Track Designation by the U.S. Food and Drug Administration for the acute treatment of agitation in patients with schizophrenia, bipolar disorders, and dementia. BXCL501 has been studied in two Phase 3 trials (SERENITY I and II) for the acute treatment of schizophrenia related agitation and bipolar disorder related agitation, respectively, and in a Phase 1b/2 trial (TRANQUILITY) for the acute treatment of dementia related agitation. This product candidate is also currently being evaluated in a Phase 1b/2 trial (RELEASE) for the treatment of opioid withdrawal symptoms and in a Phase 2 trial (PLACIDITY) for the treatment of delirium related agitation..
BioXcel Therapeutics, Inc.
BioXcel Therapeutics, Inc. is a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology. BioXcel’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. BioXcel’s two most advanced clinical development programs are BXCL501, an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine for the treatment of agitation and opioid withdrawal symptoms, and BXCL701, an investigational, orally administered, systemic innate immunity activator in development for the treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors. For more information, please visit www.bioxceltherapeutics.com.
Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include but are not limited to the timing and data from the Phase 2 PLACIDITY trial for BXCL501, synergy of the delirium indication with the Company’s planned commercial structure, value of BXCL501 as a treatment option, and the Company’s planned new drug application. When used herein, words including “anticipate,” “being,” “will,” “plan,” “may,” “continue,” and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon BioXcel’s current expectations and various assumptions. BioXcel believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain.
BioXcel may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; its limited experience in drug discovery and drug development; its dependence on the success and commercialization of BXCL501 and BXCL701 and other product candidates; the failure of preliminary data from its clinical studies to predict final study results; failure of its early clinical studies or preclinical studies to predict future clinical studies; its ability to receive regulatory approval for its product candidates; its ability to enroll patients in its clinical trials; undesirable side effects caused by BioXcel’s product candidates; its approach to the discovery and development of product candidates based on EvolverAI is novel and unproven; its exposure to patent infringement lawsuits; its ability to comply with the extensive regulations applicable to it; impacts from the COVID-19 pandemic; its ability to commercialize its product candidates; and the other important factors discussed under the caption “Risk Factors” in its Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020, as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investors section of our website at www.bioxceltherapeutics.com.
These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While BioXcel may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing BioXcel’s views as of any date subsequent to the date of this press release.
Investor Relations:
Mary Coleman
BioXcel Therapeutics, VP of Investment Relations
[email protected]
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John Graziano
Solebury Trout
[email protected]
1.646.378.2942
Media:
Julia Deutsch
Solebury Trout
[email protected]
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Artificial Intelligence
Lucinity Wins the Microsoft Partner Awards for 2024 for Partner of the Year – Iceland and Sustainability and Social Impact
REYKJAVÍK, Iceland, May 28, 2024 /PRNewswire/ — Lucinity, a leading AI company for financial crime prevention, won two awards at the Microsoft Partner Awards for 2024, including Partner of the Year – Iceland and Sustainability and Social Impact, highlighting Lucinity’s innovations and contribution to positive societal change.
“Congratulations to Lucinity for being recognized as the Partner of the Year – Iceland 2024! Lucinity is leading digital transformation and delivering innovative products in their domain,” says Microsoft’s leadership.
“For the past year, they have played a key role with their offerings, skilled resources, and their ability to drive change and innovative solutions both locally in Iceland and across the globe. Lucinity has had significant social impact and growth while supporting our joint customers in their AI-transformation journeys.”
In June 2023, Lucinity launched the world’s first copilot for FinCrime prevention powered by Microsoft Azure OpenAI called Luci. Luci stands out in the financial services industry with specialized skills for FinCrime prevention such as adverse media checks, case analysis, and SAR writing.
Built on the robust and scalable Microsoft Azure platform, Lucinity offers customers a trusted SaaS product. Additionally, Lucinity’s presence on the Microsoft Azure Marketplace allows companies to leverage their Microsoft Azure credits to access the platform.
The seamless integration with Microsoft’s Azure stack has enabled Lucinity to implement advanced AI capabilities, fostering rapid innovation and enabling banks and fintech companies to utilize AI securely and audibly. Furthermore, Luci significantly reduces investigation times from 2.5 hours to just 25 minutes, saving Tier 1 banks an estimated $25 million annually.
Guðmundur Kristjánsson (GK), Lucinity’s Founder and CEO comments, “These awards are a testament to the strength and reliability of our solutions, made possible by our strategic partnership with Microsoft. Utilizing Microsoft Azure, we have been able to drive rapid innovation and create a robust, scalable platform that meets the rigorous requirements of compliance teams.”
On the Sustainability and Social Impact Partner Award, Microsoft says, “Lucinity, with their innovative AI solutions, has really tried to combat this huge global challenge. They use ‘Human AI’ to enhance financial crime prevention, combining AI with human expertise for efficient, user-friendly solutions. Additionally, Lucinity has developed a tool called Luci, an AI-powered copilot that helps transform financial crime prevention from a process that took hours to one that takes minutes.”
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Artificial Intelligence
GIGABYTE Pioneers AI PC Market with AI Innovations and Leading Silicon Partnerships
TAIPEI, May 28, 2024 /PRNewswire/ — As COMPUTEX 2024 approaches, top chip suppliers and PC manufacturers are gearing up to unveil their latest AI innovations. The world’s leading computer brand, GIGABYTE is no exception. Following its “AI Strategy” aimed at the consumer PC market, GIGABYTE continues collaborating with Intel, NVIDIA, and AMD to maximize AI chip performance. This year, GIGABYTE solidifies its leadership in the AI PC market with exclusive AI Nexus technology and deep partnerships with NVIDIA and Microsoft. With Microsoft’s release of the next-generation Copilot and Copilot+ PCs, GIGABYTE has proactively integrated AI services and technologies into its platforms. Over 40% of its laptops feature dedicated Copilot keys, offering a seamless AI experience and showcasing GIGABYTE’s market leadership.
GIGABYTE’s new gaming laptops introduce the groundbreaking AI Nexus technology, enhancing user experience with three key functions. Gamers demand high performance, and AI Boost leverages AI for higher performance through overclocking during intense gaming sessions. However, increased power may reduce battery life. AI Power Gear intelligently extends battery life by automatically shutting off the dGPU when the laptop is unplugged, ensuring longer on-the-go usage. Additionally, AI Generator offers on-device generative AI utilities, enabling quick startups and seamless transitions between applications. With these features, GIGABYTE redefines the gaming experience, providing the ultimate edge in performance and convenience.
GIGABYTE’s close collaboration with NVIDIA ensures all AI gaming laptops feature NVIDIA® GeForce RTX™ 40 series Laptop GPUs, supporting high-demand software like Stable Diffusion and Adobe Firefly. Some models, powered by the latest Intel® Core™ Ultra processors, integrate Neural Processing Units (NPUs) to reduce CPU load, resulting in energy-efficient operation, accelerated AI processing, and significantly improved battery life. GIGABYTE’s strategic partnership with Microsoft ensures seamless Copilot technology integration into its AI laptops. With dedicated Copilot keys featured in over 40% of GIGABYTE AI laptops, users effortlessly access Microsoft services, underscoring GIGABYTE’s forward-thinking approach and close collaboration with Microsoft in the AI PC domain.
GIGABYTE continues to drive AI technology applications, delivering exceptional user experiences. Ahead of COMPUTEX 2024, GIGABYTE will unveil new AI devices and solutions, showcasing several AI PCs and presenting a comprehensive blueprint for its AI advancements. This reaffirms GIGABYTE’s leadership in the AI PC market and its commitment to building a robust AI ecosystem with industry leaders. For more information, visit: https://bit.ly/GIGABYTE_COMPUTEX__2024
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Artificial Intelligence
Cloud ITSM Market worth $17.8 billion by 2029- Exclusive Report by MarketsandMarkets™
CHICAGO, May 28, 2024 /PRNewswire/ — The market for cloud ITSM is expected to develop significantly in the future due to the growing use of multi-cloud and hybrid settings, as well as advances in automation, analytics, and artificial intelligence. The market will be shaped by an emphasis on security, edge computing, and user experience in conjunction with DevOps and remote and hybrid work patterns that will promote innovation and sustainability.
The Cloud ITSM Market size is expected to grow from USD 9.5 billion in 2024 to USD 17.8 billion by 2029 at a Compound Annual Growth Rate (CAGR) of 13.5% during the forecast period, according to a new report by MarketsandMarkets™. As the Internet of Things (IoT), 5G, and AI gain wider acceptance, numerous sectors are embracing this technology to harness real-time data for improved decision-making. While the influence of IoT and AI is widely acknowledged in fields like retail and healthcare, it is now significantly transforming industries requiring innovation, including manufacturing, transportation & logistics, energy & utilities, food and beverage, and waste management. In conjunction with IoT, Cloud ITSM offers organizations a resilient framework for instantaneously analyzing crucial data, ushering in a new era of efficiency and agility.
Browse in-depth TOC on “Cloud ITSM Market”
288 – Tables 63 – Figures326 – Pages
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Scope of the Report
Report Metrics
Details
Market size available for years
2019-2029
Base year considered
2023
Forecast period
2024–2029
Forecast units
Value (USD Billion)
Segments Covered
Offering, Deployment Mode, Organization Size, and Vertical
Regions covered
North America, Europe, Asia Pacific, Middle East & Africa, and Latin America
Companies covered
ServiceNow (US), BMC Software (US), Broadcom (US), ManageEngine (US), Ivanti (US), Zendesk (US), Freshworks (US), SolarWinds (US), Atlassian (Australia), OpenText (US), Microsoft (US), IBM (US), GOTO (US), IFS (Sweden), SymphonyAI Summit (US), Efecte (Finland), EasyVista (US), ITarian (US), SysAid Technologies (Israel), InvGate (Argentina), Alemba (UK), Hornbill (UK), NinjaOne (US), HaloITSM (US), Aisera (US), 4ME (US), TOPdesk (Netherlands), TeamDynamix (US)
The Service Desk Software segment will record the highest CAGR under Offerings during the forecast period.
The service desk software solutions in the Cloud ITSM Market have revolutionized how organizations handle IT service requests and incidents. These cloud-based platforms provide a centralized and accessible interface for managing all service desk operations, ensuring that issues are logged, tracked, and resolved efficiently. The scalability of cloud technology allows businesses to adapt to changing demand without significant infrastructure investments. Service Desk Software often includes features such as automated ticketing systems, self-service portals, knowledge bases, and integrated communication tools, which streamline the support process and enhance user experience. Additionally, advanced analytics and reporting tools offer valuable insights into service desk performance, enabling continuous improvement in service delivery. Integrating AI and machine learning further enhances these solutions by enabling predictive analytics, automated responses, and intelligent routing of requests. As a result, Service Desk Software solutions in the Cloud ITSM Market empower organizations to provide prompt, effective and cost-efficient IT support, driving higher customer satisfaction and operational efficiency.
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Based on Organization Size, Large Enterprises hold a larger share of the Cloud ITSM Market during the forecast period.
Large enterprises are set to lead the cloud IT Service Management (ITSM) market during the forecast period. Their dominance is attributed to the need to manage extensive and intricate IT infrastructures, which demand robust and scalable ITSM solutions. These companies heavily invest in advanced cloud ITSM platforms to optimize operations, improve service delivery, and comply with industry regulations. Cloud ITSM adoption offers significant flexibility, efficiency, and cost benefits, which are crucial for large-scale operations. Consequently, large enterprises utilize these comprehensive solutions to maintain a competitive edge and achieve operational excellence in an increasingly digital business landscape.
By region, Asia Pacific will record the highest CAGR during the forecast period.
The Asia Pacific Cloud ITSM Market is experiencing robust growth driven by regulatory reforms, Scalable resources, Cost reduction, Remote flexibility, Business agility, and technological innovation. Countries like China, Japan, Australia & New Zealand have progressive regulatory frameworks promoting competition and innovation. The affordability and ease of Cloud ITSM deployment would be the major driving factors for adopting cloud technologies. The Asia Pacific region is witnessing rapid growth in the Cloud ITSM Market, driven by the increasing adoption of IoT devices, AI, and the expansion of 5G networks. Countries like China and Japan are at the forefront, leveraging Cloud ITSM to enhance BFSI services, innovative data migration, and retail and healthcare services. Additionally, the proliferation of cloud services and the rise of digital transformation initiatives in various industries further propel the demand for Cloud ITSM solutions. As a result, the Asia Pacific region is bound to experience significant investment and innovation in Cloud ITSM technologies over the coming years, facilitating efficient data processing and enabling real-time decision-making across diverse sectors in countries, especially China, Japan, Australia & New Zealand, and others.
Top Key Companies in Cloud ITSM Market:
Some of the key players operating in the Cloud ITSM Market are ServiceNow (US), BMC Software (US), Broadcom (US), ManageEngine (US), Ivanti (US), Zendesk (US), Freshworks (US), Solarwinds (US), Atlassian (Australia), OpenText (US) among others.
Recent Developments
In April 2024, At the Relate global conference, Zendesk unveiled a collaboration with Amazon Web Services (AWS) and Anthropic to enhance AI capabilities. By leveraging Amazon Bedrock and Anthropic’s Claude 3 model family, Zendesk aims to provide faster, more accurate AI features. This partnership enables businesses to deliver personalized customer experiences, empower agents with AI tools, and improve customer satisfaction through intelligent, empathetic support.In February 2024, ServiceNow and NVIDIA expanded their partnership to introduce telco-specific generative AI solutions, enhancing service experiences. Built on the Now Platform, Now Assist for Telecommunications Service Management leverages NVIDIA AI to boost productivity, speed up resolution times, and improve customer service. This collaboration aims to help telcos reduce costs, uncover new business opportunities, and drive industry-wide transformation.In February 2024, Amdocs and BMC announced a strategic alliance to enhance digital operations in telecommunications and financial services. This partnership leverages Amdocs’ IT and network expertise with BMC’s automation solutions to drive growth and efficiency. Together, they will offer integrated services, including generative AI, to accelerate innovation and operational excellence for global customers.In November 2023, ServiceNow introduced enhancements in its Now Assist generative AI portfolio with new capabilities to improve experiences and increase efficiency. With this, Now Assist in Virtual Agent, flow generation, and Now Assist for Field Service Management (FSM) will be the newest sophisticated Generative AI technologies to be embedded into the ServiceNow Platform.In November 2023, BMC software introduced generative AI capabilities in the Helix Service Management solution, enhancing security measures and providing AI-driven insights. Recognized as a leader in enterprise service management and AIOps, BMC Helix offers resolution insights, unified workflows for security and operations teams, industry-specific templates, and broader low code/no code platform capabilities. These innovations underscore BMC’s commitment to driving meaningful innovation and helping organizations achieve autonomy in the digital landscape.Inquire Before Buying@ https://www.marketsandmarkets.com/Enquiry_Before_BuyingNew.asp?id=261087410
Cloud ITSM Market Advantages:
Pay-as-you-go cloud ITSM offers an alternative to large upfront investments in software and hardware, potentially reducing total IT costs. Because the service provider handles maintenance and upgrades, it also reduces costs.Cloud ITSM solutions are easily scalable to meet the demands of the business. Because of this flexibility, companies can modify services and resources to meet their needs without investing too much or not enough.ITSM solutions are accessible from any location with an internet connection because they are cloud-based. This guarantees that end users and IT teams may access services and assistance from anywhere in the world and facilitates remote work.Software upgrades and maintenance are handled by cloud ITSM providers, guaranteeing that businesses always have access to the newest features, security updates, and enhancements without any manual labour or downtime.Compared to conventional on-premises systems, cloud ITSM solutions can be implemented considerably faster. The time-to-value is accelerated by this quick deployment, which enables organisations to take advantage of the ITSM capabilities sooner.Cloud ITSM products frequently come with features that make it easier for IT teams and end users to collaborate. Real-time updates, shared dashboards, and integrated communication tools all contribute to increased efficiency and cooperation.Robust incident management features, including as automatic ticketing, real-time monitoring, and analytics, are provided by cloud ITSM platforms. By assisting IT staff in swiftly locating, ranking, and resolving problems, these features enhance user happiness and service quality.Report Objectives
To define, describe, and forecast the global Cloud ITSM Market based on offering, deployment mode, organization size, vertical, and region.To forecast the market size of the five major regional segments: North America, Europe, Asia Pacific, Middle East & Africa, and Latin AmericaTo strategically analyze the market subsegments concerning individual growth trends, prospects, and contributions to the total marketTo provide detailed information related to the major factors influencing the growth of the market (drivers, restraints, opportunities, and challenges)To strategically analyze macro and micro markets for growth trends, prospects, and their contributions to the overall marketTo analyze industry trends, patents and innovations, and pricing data related to the Cloud ITSM Market.To analyze the opportunities in the market for stakeholders and provide details of the competitive landscape for major players.To profile key players in the market and comprehensively analyze their market share/ranking and core competencies.To track and analyze competitive developments, such as mergers & acquisitions, product developments, and partnerships & collaborations in the market.Browse Adjacent Markets: Cloud Computing Market Research Reports & Consulting
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