Artificial Intelligence
BioXcel Therapeutics Initiates Pivotal Phase 3 Program of BXCL501 for Acute Treatment of Agitation in Patients with Alzheimer’s Disease
Two Phase 3 studies to enroll a total of 300 patients in assisted living or residential facilities and nursing homes to evaluate the safety and efficacy of BXCL501
Studies designed to maximize BXCL501 opportunity to treat full spectrum of agitation, with an estimated 100 million agitation episodes in Alzheimer’s patients occurring in the U.S. annually
No FDA approved therapies for treatment of agitation associated with Alzheimer’s
NEW HAVEN, Conn., Dec. 15, 2021 (GLOBE NEWSWIRE) — BioXcel Therapeutics, Inc. (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 its pivotal Phase 3 program for BXCL501, the Company’s proprietary, orally dissolving thin film formulation of dexmedetomidine, for the acute treatment of agitation in patients with Alzheimer’s disease (AD). The program’s two studies, TRANQUILITY II and TRANQUILITY III, are designed to evaluate the safety and efficacy of BXCL501 in adults 65 years and older in assisted living or residential facilities and nursing homes.
“We received FDA breakthrough therapy designation for BXCL501 in March 2021 based on our Phase 1b/2 TRANQUILITY study. Following multiple meetings with the FDA, we are pleased to announce the initiation of our Phase 3 program,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “This marks an important advancement in potentially bringing this novel treatment to the more than 4 million patients, who experience agitation as one of AD’s most devastating symptoms. We are leading the development path for this innovative therapy and are confident in BXCL501’s potential to treat acute, as well as intermittent, forms of agitation.”
The program expands the evaluation of patients in diverse medical settings across the range of dementia severity. It is designed to maximize the opportunity of BXCL501 for the treatment of the full spectrum of agitation associated with AD.
Pivotal Phase 3 Program Summary
- The program will consist of two randomized, placebo-controlled, adaptive, parallel group pivotal trials, TRANQUILITY II and TRANQUILITY III.
- Each study will enroll 150 dementia patients 65 years and older. Patients will self-administer 40 mcg or 60 mcg of BXCL501 or placebo whenever agitation episodes occur over a three-month period.
- TRANQUILITY II will enroll patients in assisted living or residential facilities requiring minimal assistance with activities of daily living. TRANQUILITY III will enroll patients in nursing homes with moderate to severe dementia requiring moderate or greater assistance with activities of daily living.
- The studies are designed to assess agitation as measured by the changes from baseline in the Positive and Negative Syndrome Scale-Excitatory Component (PEC) and Pittsburgh Agitation Scale (PAS) total scores. The primary efficacy endpoint for both studies will be change in PEC score from baseline measured at two hours after the initial dose and subsequent doses.
- Patients who complete TRANQUILITY II or TRANQUILITY III will be eligible to enroll in an open label, 52-week safety study designed to measure the safety and efficacy of BXCL501 in continued use.
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 associated with neuropsychiatric disorders. BioXcel Therapeutics believes that BXCL501 potentially targets a causal agitation mechanism, and the Company has observed anti-agitation results in multiple clinical studies across several neuropsychiatric disorders, including schizophrenia-related agitation (SERENITY I), bipolar disorder-related agitation (SERENITY II) and dementia-related agitation (TRANQUILITY). BXCL501 has been granted Breakthrough Therapy designation for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders and dementia. The safety and efficacy of BXCL501 has not been established.
About Alzheimer’s Disease
Alzheimer’s disease is the most prevalent type of dementia in the United States. By 2040, approximately 12 million Americans aged 65 years and over are expected to be impacted by the condition, double the approximately 6 million Americans impacted in 2020.1,2 Of these patients, up to 70% experience agitation, with an estimated 100 million agitation episodes occurring in the United States every year.3,4 There are no approved therapeutic options for the acute treatment of agitation related to dementia, including Alzheimer’s disease.
About TRANQUILITY
The randomized, double-blind, placebo-controlled, ascending dose, adaptive Phase 1b/2 study was designed to evaluate the efficacy, pharmacokinetics, safety, and tolerability of BXCL501 in adults 65 years and older who exhibit acute agitation associated with all forms of dementia, including Alzheimer’s disease. Following the completion of each dose cohort, a safety and tolerability review was performed to determine the next tested dose. The study was designed to assess agitation as measured by the changes from baseline in PAS and PEC total scores, as well as by improvements from baseline in the Mod-CMAI total score.
About the Positive and Negative Syndrome Scale-Excitatory Component Score (PEC or PANSS-EC)
The PEC total score is a validated endpoint for measuring acute agitation in schizophrenia and bipolar patients. This scale is used in clinical research to quantify the severity of a patient’s acute agitation. The PEC rating evaluates 5 elements associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC total score is the sum of these 5 elements and thus ranges from 5 to 35.
About the Pittsburgh Agitation Scale (PAS)
PAS is a validated instrument used to monitor the severity of agitation associated with dementia. The PAS measures 4 behavior groups: aberrant vocalization, motor agitation, aggressiveness, and resisting to care. The groups are evaluated on a scale from 0 to 4, with 0 defined as no agitation present and 4 defined as the highest form of agitation. The PAS total score ranges from 0 to 16.
About 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. The Company’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 Therapeutics’ two most advanced clinical development programs are BXCL501, an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine for the treatment of agitation associated with psychiatric and neurological disorders, 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 TRANQUILITY II and TRANQUILITY III trials and the potential value of BXCL501 as a treatment option for agitation in patients with AD, and future financial and operational results. When used herein, words including “anticipate,” “will,” “plan,” “may,” “continue,” “intend,” “designed,” “goal” 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 the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company 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, BXCL502 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 the Company’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, 2021, 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. 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 the Company 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 the Company’s views as of any date subsequent to the date of this press release.
Contact Information
Corporate
BioXcel Therapeutics
Erik Kopp
1.203.494.7062
[email protected]
Investor Relations
FTI Consulting
Matt Ventimiglia
1.212.850.5624
[email protected]
Media
FTI Consulting
Helen O’Gorman
1.718.408.0800
[email protected]
Source: BioXcel Therapeutics, Inc.
1 Prevalence of bipolar disorder in adults. November 2017. Accessed June 24, 2021. https://www.hcp.med.harvard.edu/ncs/ftpdir/NCS-R_12-month_Prevalence_Estimates.pdf
2 Alzheimer’s Association
3 Tractenberg, R Neuropsychiatry Clin Neuroscience 14:1 Winter 2002
4 Estimate based on company market research
Artificial Intelligence
How AIoT shapes the future of mobility: Hikvision at ITS World Congress 2024
HANGZHOU, China, Sept. 27, 2024 /PRNewswire/ — Hikvision made a significant impact at the ITS World Congress in Dubai with its captivating theme, “Embrace AIoT for safer, smarter, and greener mobility.” Its booth became a hub of innovation, where visitors explored AIoT solutions that are reshaping the transportation landscape, sparking deep conversations on the future of urban mobility.
Road safety revolution: harnessing AIoT for secure transportation
Hikvision’s commitment to road safety was on full display at its booth through the impressive array of AIoT solutions designed to create secure and reliable traffic environments. The company’s technology provides 24/7 traffic monitoring, ensuring continuous oversight of motor vehicles, non-motorized vehicles, pedestrians and environmental factors. This comprehensive, real-time information collection enables traffic managers to prevent accidents and enhance road safety. Among the showcased products was the 20 MP IR ANPR Checkpoint Capture Unit, renowned for its high-definition capture capabilities, bolstering traffic safety measures.
A standout innovation was the integration of advanced radar and camera technologies, ensuring uninterrupted, comprehensive detection even in adverse weather conditions. The Radar-Video Fusion Incident Detection Cameras, featured prominently in the product experience area, enable early detection and warning of potential hazards. They are particularly effective in challenging situations such as curved roads, blind spots at intersections, and obstacles beyond visual range.
Attendees also engaged with onboard monitoring products on the simulated bus, including dome network cameras, which is designed to enhance passenger safety. Driving assistance products, such as the Driver Status Monitor (DSM), were demonstrated to mitigate unsafe driving behaviors and ensure safer journeys.
Urban mobility redefined: smart traffic innovations
In the realm of smarter mobility, Hikvision showcased its multidimensional sensing technology, which integrates visible light sensors, infrared sensors, radar, and sonar. This technology expands perception capabilities, significantly improving traffic management and situational awareness. The use of AI-powered comprehensive sensing elevates incident monitoring and violation detection to unprecedented levels of accuracy and efficiency.
A major attraction was the Radar-Video Fusion TandemVu PTZ Camera, which integrates millimeter-wave radar with high-resolution cameras for extensive traffic detection and data analysis. AI-based algorithms combine these two systems to enhance target information, detecting up to 16 types of incidents. This leads to the development of a large-scale fusion model that merges spatial physical data with image semantic information. The result is ultra-long-range perception, achieving over 95% accuracy in vehicle trajectory detection. This robust system improves traffic violation management and optimizes traffic flow, significantly enhancing road efficiency.
At the simulated bus station, visitors observed how AI-assisted people counting automated the collection of passenger flow statistics at peak stop hours and bus line frequency during busy periods. Paired with smart bus stop digital signage, the solution improves bus service quality, operational efficiency, passenger experience, and overall public transport effectiveness.
Sustainable transportation: leading the charge for greener cities
Hikvision’s commitment to sustainable urban mobility was evident through its innovative green wave technology and eco-friendly checkpoint solutions. Green wave technology efficiently manages traffic flow to reduce congestion and lower carbon emissions, aligning with global sustainability goals. Visitors were particularly impressed by a case study showcasing a green wave solution implemented in Zhoushan, China. Over a stretch of 21 kilometers and 34 intersections, this main road cut travel times by 50%.
The use of DarkFighterX technology in checkpoint cameras also received significant attention. This technology senses both visible and invisible light, resulting in more accurate and realistic images. It enhances traffic violation enforcement efficiency while minimizing the need for high ambient light levels, thus reducing light pollution. The 9M DarkfightX ANPR Checkpoint Camera exemplified this dedication to environmental stewardship.
Frank Zhang, President of Hikvision MEA, remarked, “Hikvision supports sustainable urban planning by empowering traffic departments to address congestion and transportation challenges.” He further emphasized, “Our system’s openness fosters a secure and reliable platform for developing smart and green cities. Additionally, our solar technology is extensively utilized in remote areas, while our smart street lighting solutions reduce energy consumption by 20-30%, promoting intelligent urban transportation and advancing global sustainability objectives.”
Hikvision’s presence at the ITS World Congress in Dubai underscored its leadership in integrating AIoT technologies to drive safer, smarter, and greener mobility solutions. The engaging presentations and advanced product demonstrations captured significant attention from industry partners and customers, reaffirming the company’s role as a pioneer in shaping the future of urban transportation. As the world moves towards more intelligent and sustainable transportation systems, Hikvision remains at the forefront, embracing AIoT to create a safer, smarter, and greener future for all.
To find out more about Hikvision’s advanced traffic and public transport solutions, please explore the Hikvision official website.
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Artificial Intelligence
Anti-Drone Market worth $7.05 billion by 2029 – Exclusive Report by MarketsandMarkets™
DELRAY BEACH, Fla., Sept. 27, 2024 /PRNewswire/ — The global anti-drone market was valued at USD 2.16 billion in 2024 and is projected to reach USD 7.05 billion by 2029; it is expected to register a CAGR of 26.7% during the forecast period according to a new report by MarketsandMarkets™. Increasing government spending on counter-drone technologies, rising incidence of critical infrastructure security breaches by unauthorized drones, and surge in adoption of aerial remote sensing technologies to safeguard critical infrastructure are attributed to the demand for anti-drone.
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Browse in-depth TOC on “Anti-Drone Market” 178 – Tables61 – Figures253 – Pages
Anti-Drone Market Report Scope:
Report Coverage
Details
Market Revenue in 2024
$ 2.16 billion
Estimated Value by 2029
$ 7.05 billion
Growth Rate
Poised to grow at a CAGR of 26.7%
Market Size Available for
2020–2029
Forecast Period
2024–2029
Forecast Units
Value (USD Million/Billion)
Report Coverage
Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
Segments Covered
By System Type, Application, Platform type, Vertical, and Region
Geographies Covered
North America, Europe, Asia Pacific, and Rest of World
Key Market Challenge
Vulnerability to hacking
Key Market Opportunities
Emphasis on improving unmanned aircraft systems technology
Key Market Drivers
Growing number of illicit activities
By System Type: Hybrid systems to account for the larger market share in the forecasted year.
The hybrid segment accounted for the largest share of the anti-drone market in 2029. The trends of integrating multiple anti-drone technologies are rising since they are most effective in detecting, tracking, and neutralizing drone threats. These systems merge electronic, kinetic, and lasers, providing a comprehensive defense solution against UAVs. Hybrid systems use electronic, kinetic, and laser-based countermeasures to offer optimum protection against drones. These systems are designed to detect, track, identify, categorize, and mitigate drones at operational wide ranges ranging from a few km up to tens of km.
By Platform: The ground-based segment accounted for the largest market share in the forecast year.
The ground-based segment will hold a major share of the anti-drone market in 2029. Many ground-based anti-drone systems use several electronic technologies, such as radar, IR sensors, acoustic systems, and RF & GNSS jammers. MESA radar solutions are used mostly for counter-UAS purposes, protecting critical infrastructure, military camps, and other security-sensitive sites from unauthorized drones. One such solution is EchoGuard, a ground-based airspace management solution that contains a software-defined 3D radar that can be specific to the site. This system can identify single or multiple off-chance drones, including swarms in unauthorized areas. They provide accurate and sustained airspace surveillance for the field of view (FOV) they are configured, and both human and AI-monitored visual checks. The system can be easily transported and integrated directly with the command-and-control centers or another identification sensor for portable use, and multiple units of the system can be combined to cover vast areas or lengths of borders. Major providers of ground-based counter-drone systems include companies like EchoDyne Corporation, DeTect, Meteksan Defense, and WhiteFox Defense. Acoustics-based Discovair G2 utilizes patented microphone arrays. With 128 interconnected microphone elements, the Discovair sensor units can establish azimuth and elevation to the target in real-time using advanced digital signal processing.
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By Region: Americas are expected to hold the largest share of the anti-drone market during the forecast period.
Americas is expected to capture the largest share in the anti-drone industry during the forecast period. The growth can be attributed to protecting crucial infrastructure in the region. Governments, particularly in the US, invest in anti-drone systems for military bases, borders, and critical infrastructure. For Instance, in April 2023, RTX secured a USD 237 million contract from the US Army to provide Ku-band Radio Frequency Sensors (KuRFS) and Coyote effectors. These systems are designed to detect and neutralize unmanned aircraft systems (UAS). The contract includes stationary and mobile systems and a specified quantity of effectors, all aimed at enhancing the Army’s operations within the US Central Command region.
Key Players-
The key companies offering anti-drone companies include RTX (US), Lockheed Martin Corporation (US), Leonardo S.p.A. (Italy), Thales (France), and IAI (Israel).
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Artificial Intelligence
CluePoints Launches Medical & Safety Review (MSR) Software to Revolutionize Clinical Data Review
CluePoints furthers its commitment to delivering innovative solutions that enhance clinical trial efficiency with this latest addition to its enterprise software platform.
KING OF PRUSSIA, Pa., Sept. 27, 2024 /PRNewswire/ — CluePoints continues to transform clinical trial review and leverage its industry-leading software to enhance the interrogation, analysis and presentation of data with the launch of its latest application, Medical & Safety Review (MSR).
The tool simplifies and streamlines the medical analysis of study data through user-friendly dashboards, data manipulation and cleaning, query management and full transparency over the data history. This not only improves efficiency and communication in medical oversight, but also elevates patient safety, differentiating MSR as a smarter and unique solution.
Designed by, and for Medical and Safety Reviewers, MSR converts the manual analysis of patient outcomes, which can be prone to inefficiency and error, into an accurate, efficient process. MSR tackles time-consuming study preparation for specific visualizations by featuring a comprehensive standard visualization library as well as the ability to copy and reuse dashboards across different studies, enabling the identification of outlying values, change tracking, and improved communication for smarter clinical trials.
Other benefits of MSR include:
Enhanced medical review efficiency and reduced human errors via automated checksReduced time spent by clinical and data management teams in reviewing dataImproved collaboration with integrated review workflows across departmentsEnsured record quality and accountability with comprehensive change trackingDriving faster decision making with the proactive detection of trends and safety issuesEnsuring regulatory compliance with rule-based detection and user assignmentsAndy Cooper, Chief Executive Officer at CluePoints, commented, “We are thrilled to announce the launch of Medical & Safety Review to our growing product offerings. MSR is the latest application addition to the CluePoints platform, which includes products such as Risk-Based Quality Management (RBQM) and our Site Profile & Oversight Tool (SPOT). Together, they provide a comprehensive approach to clinical trial optimization, enhancing data integrity, ensuring regulatory compliance, and accelerating drug development. The creation of MSR ensures a more streamlined review process while prioritizing patient safety at every step and empowers medical teams to swiftly identify outliers, track data changes, and improve communication.”
To learn more about CluePoints’ award-winning solutions, please visit www.cluepoints.com
About CluePoints
CluePoints is the premier Risk-Based Quality Management (RBQM) and Data Quality Oversight Software provider. We are leveraging the potential of Artificial Intelligence using Advanced Statistics and Machine Learning to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the FDA, EMA, and ICH E6 (R2), CluePoints is deployed to support central and on-site monitoring, medical review, quality risk management and to drive a holistic Risk-Based strategy in all trials. Coupled with thought leadership and consulting expertise to aid pre-study risk assessment, identification of risk controls and solution implementation, you now have everything you need to adhere with global regulatory guidance. The result is positive clinical development outcomes, increased operational efficiency, lower costs and reduced regulatory submission risk as part of the industry paradigm shift to RBQM.
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