Artificial Intelligence
BioXcel Therapeutics Announces FDA Clearance of IND Application for BXCL501 for the Treatment of Opioid Withdrawal Symptoms
NEW HAVEN, Conn., Feb. 05, 2020 (GLOBE NEWSWIRE) — BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to identify and advance the next wave of medicines in neuroscience and immuno-oncology, today announced that its Investigational New Drug (“IND”) application for BXCL501, the Company’s proprietary sublingual thin-film formulation of dexmedetomidine (“Dex”), has received clearance from the U.S. Food and Drug Administration (“FDA”) for the treatment of opioid withdrawal symptoms.
“The FDA clearance of our IND application for opioid withdrawal, a fourth indication, is an important step in our plans to build a neuroscience franchise around the multiple therapeutic opportunities with BXCL501,” commented Vimal Mehta, Chief Executive Officer of BTI. “Opioid overdose is reported as the number one cause of death for those under 50 years old in the U.S., and the distressing and challenging symptoms that come with opioid withdrawal are a primary reason for relapse. There is an urgent need for better treatment options to help manage the debilitating withdrawal symptoms and aid this underserved population from continued opioid abuse. BXCL501, our investigational non-opioid therapy, may offer key advantages to treating symptoms due to its intrinsic potency and favorable delivery method. We believe this study will build on the encouraging results we observed in our intravenous (“IV”) Dex trial, which appeared effective in reducing opioid withdrawal symptoms.”
Opioid withdrawal is an emotional and physiological medical condition that may be driven by the excessive drive of noradrenergic neurons that originate from the locus coeruleus in the brainstem. BXCL501 selectively activates alpha-2a adrenergic receptors, which decreases excessive neuronal firing, alleviating the physiological symptoms of opioid withdrawal.
The RELEASE trial is a multicenter, randomized, double-blind, placebo-controlled, ascending-dose Phase 1b/2 study designed to evaluate the safety, pharmacokinetics, tolerability and efficacy of BXCL501 in patients experiencing symptoms of opioid withdrawal. This study will enroll subjects with opioid use disorder who are physically dependent on opioids. Patients will be randomized into multiple dose cohorts of BXCL501, or matching placebo, administered twice daily for five days. The study will assess opioid withdrawal symptoms using both the Clinical Opiate Withdrawal Scale and Short Opiate Withdrawal Scale of Gossop over a 10-day period.
About BXCL501 A Phase 1b safety and efficacy study of BXCL501 yielded positive dose-response data. BXCL501 is being evaluated in the SERENITY program, consisting of two Phase 3 studies for the acute treatment of agitation in patients with schizophrenia (SERENITY I) and bipolar disorder (SERENITY II). BXCL501 is also being evaluated in a Phase 1b/2 trial for the treatment of agitation associated with dementia, and the Company is preparing to initiate the Phase 1b/2 RELEASE trial of BXCL501 for the treatment of opioid withdrawal symptoms.
About Opioid Drug Withdrawal:
According to the Centers for Disease Control and Prevention (CDC), the misuse of and addiction to opioids is a serious national crisis and is the leading cause of death in the U.S. for those under 50 years old. Between 1999-2017, almost 400,000 people died from an overdose involving an opioid, with greater than 47,000 deaths occurring in 2017 alone. The CDC estimates the total “economic burden” of prescription opioid misuse alone in the U.S. is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment and criminal justice involvement. Opioid withdrawal is a condition characterized by symptoms such as anxiety, agitation, sleep problems, muscle aches, runny nose, sweating, nausea, vomiting, diarrhea and drug craving — that occur after stopping or reducing the use of opioids in anyone with physical dependence on opioids.
About BioXcel Therapeutics, Inc. Forward-Looking Statements 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 BTI 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 BTI’s views as of any date subsequent to the date of this press release.
BioXcel Therapeutics, Inc. Investor Relations: Media: Source: BioXcel Therapeutics, Inc.
BXCL501 is a potential first-in-class, proprietary sublingual thin film of dexmedetomidine, a selective alpha-2a receptor agonist for the treatment of acute agitation. BTI believes that BXCL501 directly targets a causal agitation mechanism and the Company has observed anti-agitation effects in multiple clinical studies across multiple neuropsychiatric indications. BXCL501 has also been granted Fast Track Designation by the U.S. Food and Drug Administration for the acute treatment of agitation.
BioXcel Therapeutics, Inc. is a clinical stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology. BTI’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. BTI’s two most advanced clinical development programs are BXCL501, a sublingual thin film formulation designed for acute treatment of agitation resulting from neuropsychiatric disorders, and BXCL701, an orally administered systemic innate immunity activator designed for treatment of a rare form of prostate cancer, pancreatic cancer and advanced solid cancers in combination with other immuno-oncology agents. For more information, please visit http://www.bioxceltherapeutics.com/.
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 effects of BXCL501 treatment on opioid withdrawal symptoms and the timing of clinical development initiatives and trials for BXCL501. 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 BTI’s current expectations and various assumptions. BTI believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. BTI 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; 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; 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, 2019, 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 on the Company’s website at www.bioxceltherapeutics.com.
www.bioxceltherapeutics.com
John Graziano
[email protected]
1.646.378.2942
Julia Deutsch
[email protected]
1.646.378.2967
Artificial Intelligence
Complyport’s new AI tool – ViCA.Chat – set to revolutionise compliance support services
LONDON, June 14, 2024 /PRNewswire/ — ViCA.Chat, the Virtual Compliance Assistant powered by AI technology, is set to transform regulatory compliance consulting. Developed by ComplyMAP Group’s AI engineers and Complyport’s compliance consulting teams, ViCA redefines compliance support services and propels governance, risk and compliance consulting into a new era of innovation.
Offering real-time assistance across a vast array of UK and EU regulatory frameworks, ViCA delivers unparalleled efficiency, detail and precision in disentangling and dealing with complicated regulatory frameworks.
The key differentiator of ViCA is its specialised and purposely constructed unique databases that leverage Complyport’s 22 years of regulatory expertise, combined with tailored AI training tools, enabling ViCA to operate as an experienced compliance consultant. A dedicated human support team continuously improves and updates ViCA’s knowledge and responses through a feedback loop process and quality assurance sessions. This powerful symbiosis of AI and human expertise sets ViCA apart and ensures businesses have the latest regulatory information instantaneously and seamlessly.
As a result, ViCA’s specialised regulatory database goes beyond readily available online resources which feature into traditional AI tools. ViCA offers exclusive insights, proprietary regulatory interpretations, historical data, bespoke and purposely structured compliance documentation and templates. With advanced scraping capabilities, ViCA also extracts relevant data from selected websites and publicly available information, ensuring an up-to-date and comprehensive understanding of compliance requirements across industries.
From agile fintech startups to established law firms, financial institutions, regulatory bodies, insurance providers, as well as compliance consultants, ViCA seamlessly adapts to unique compliance needs. Its user-friendly interface ensures navigating and analysing regulatory data is swift and intuitive, streamlining the compliance workflow.
“ViCA is a game-changer in how regulatory compliance advice will be provided in the future”, commented Luis Parra, Managing Director of ViCA. “With ViCA, compliance insights become available to all. No longer are regulated firms and responsible people overly dependent on advisors and compliance consultants. Through ViCA, the financial system will not only meet but exceed regulatory standards. Moreover, the level of information made available to the public will benefit society as a whole, in its interactions with the financial services sector.”
Among ViCA’s revolutionary features is its cost-effective model, allowing businesses to significantly reduce reliance on traditional spending with external consultants and advisors.
Visit ViCA.Chat to experience the future of compliance support.
Contact:
Name: Luis ParraTitle: Managing DirectorCompany: Vica.ChatTelephone: +44 20 7399 4980 Email: [email protected]
About ViCA.Chat:
ViCA.Chat is a revolutionary Virtual Compliance Assistant powered by cutting-edge AI technology, designed to demystify the complexities of regulatory compliance. Utilising Complyport’s 22 years of regulatory expertise, ViCA offers real-time assistance and guidance across a wide range of regulatory frameworks, setting a new standard for efficiency and precision in compliance support. From fintech start-ups to established law firms, financial services institutions, regulators, regulatory firms, compliance consultants and insurance firms, ViCA caters to the diverse needs of professionals across all levels in the broader UK financial services sector.
Visit ViCA.Chat to learn more.
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Artificial Intelligence
LoRa and LoRaWAN IoT Market worth $32.7 billion by 2029- Exclusive Report by MarketsandMarkets™
CHICAGO, June 14, 2024 /PRNewswire/ — The LoRa and LoRaWAN IoT Market is expected to reach USD 32.7 billion by 2029 from USD 8.0 billion in 2024, at a Compound Annual Growth Rate (CAGR) of 32.4 % during 2024–2029, according to a new report by MarketsandMarkets™.
Browse in-depth TOC on “LoRa and LoRaWAN IoT Market”
320 – Tables 58 – Figures294 – Pages
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Scope of the Report
Report Metrics
Details
Market size available for years
2018-2029
Base year considered
2023
Forecast period
2024–2029
Forecast units
Value (USD Billion)
Segments Covered
Offering, Network Deployment, Application, End User, and Region
Region covered
North America, Europe, Asia Pacific, Middle East & Africa, and Latin America.
List of Companies in LoRa and LoRaWAN IoT
The Bosch Group (Germany), Cisco (US), Orange SA (France), Comcast Corporation (US), Semtech (US), NEC Corporation(Japan), Tata Communications (India), AWS (US), Advantech (Taiwan), SK Telecom (South Korea), Murata (Japan), Kerlink (France), Actility (France), Digi International (US), MultiTech (US), Ezurio (US), Sensoterra (Netherlands), Nwave Technologies (US), RAKwireless (China), TheThings.io (Spain), Datacake (Germany), Milesight (China), LORIOT (Switzerland), Exosite (US), Orbiwise (Switzerland), Netmore Group (Sweden), and Radio Bridge Inc (US).
The LoRaWAN ecosystem influences development of tools, software libraries, and cloud-based platforms that streamline the creation, deployment, and management of IoT solutions. Continuously evolving, this ecosystem boasts a burgeoning array of vendors providing LoRa-compliant devices, gateways, and network management solutions. This vibrant competition within the ecosystem propels innovation while driving down costs for end-users. Moreover, the development of interoperable solutions fosters seamless integration and deployment of LoRaWAN networks, simplifying the implementation process for businesses and organizations. As the ecosystem continues to expand and mature, it empowers developers, system integrators, and IoT enthusiasts to unleash their creativity, accelerate time-to-market, and unlock the full potential of LoRaWAN technology in diverse applications and industries.
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Based on network deployment, the public network segment to hold the largest market size during the forecast period.
The robust security features integrated into public LoRaWAN networks play a significant role in driving the growth and adoption of LoRaWAN technology in the market. End-to-end encryption ensures that data transmitted between devices and gateways is protected from unauthorized access or interception, safeguarding sensitive information such as sensor readings, location data, and command messages. Message integrity checks verify the integrity of data packets, detecting any tampering or alteration during transmission and ensuring data authenticity and reliability. Additionally, mutual authentication mechanisms establish trust between devices and gateways, verifying the identity of both parties before allowing communication to occur. These security measures provide organizations and end-users with confidence in the integrity and confidentiality of their data, mitigating concerns related to data privacy, cybersecurity threats, and regulatory compliance. As a result, implementing robust security features in public LoRaWAN networks enhances trust and credibility in the technology, driving increased adoption and market growth as organizations seek reliable and secure connectivity solutions for their IoT deployments.
By offering, the services segment is expected to hold a higher growth rate during the forecast period.
IoT service providers are pivotal in driving adoption by developing vertical-specific solutions finely tuned to the distinct needs of industries like agriculture, healthcare, logistics, and smart cities. In agriculture, for instance, IoT services offer solutions for precision farming, crop monitoring, and livestock management, enabling farmers to optimize irrigation, monitor soil health, and enhance yields. Similarly, IoT services facilitate remote patient monitoring, asset tracking, and inventory management in healthcare, improving patient care, reducing costs, and ensuring compliance with regulatory standards such as HIPAA. In logistics, IoT services provide real-time tracking of shipments, fleet management, and predictive maintenance, enhancing supply chain visibility, efficiency, and reliability. For smart cities, IoT services offer solutions for traffic management, waste management, energy optimization, and public safety, transforming urban infrastructure and enhancing the quality of life for residents. By addressing industry-specific challenges, compliance requirements, and use cases, vertical-specific IoT solutions deliver tangible business value, driving adoption and fueling the growth of the IoT services market across diverse sectors.
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Asia Pacific is expected to hold a higher growth rate during the forecast period.
In the Asia Pacific region, where agriculture serves as a cornerstone of many economies, adopting IoT technologies, particularly LoRa and LoRaWAN, is revolutionizing traditional farming practices. LoRaWAN’s long-range connectivity and low-power consumption make it well-suited for deployment in rural agricultural settings, where access to reliable connectivity may be limited. Through LoRa-based IoT solutions, farmers can implement precision agriculture techniques to address pressing challenges such as water scarcity, soil degradation, and unpredictable weather patterns. LoRa-enabled sensors facilitate real-time monitoring of soil moisture levels, temperature, and humidity, allowing farmers to optimize irrigation schedules and conserve water resources. Remote sensing technologies powered by LoRaWAN enable farmers to gather actionable insights on crop health, pest infestations, and nutrient deficiencies, facilitating timely interventions and improving overall crop management practices. Furthermore, LoRa-based crop analytics platforms provide farmers with data-driven decision support tools, helping them optimize planting strategies, improve yield forecasting, and mitigate the impact of climate change on agricultural productivity. By harnessing the power of LoRa and LoRaWAN IoT solutions, farmers in the Asia Pacific region can increase yields, conserve resources, and enhance resilience to environmental challenges, driving the adoption and growth of the LoRaWAN IoT market in the agricultural sector.
Top Key Companies in LoRa and LoRaWAN IoT Market:
The major vendors covered in the LoRa and LoRaWAN IoT Market are The Bosch Group (Germany), Cisco (US), Orange SA (France), Comcast Corporation (US), Semtech (US), NEC Corporation(Japan), Tata Communications (India), AWS (US), Advantech (Taiwan), SK Telecom (South Korea), Murata (Japan), Kerlink (France), Actility (France), Digi International (US), MultiTech (US), Ezurio (US), Sensoterra (Netherlands), Nwave Technologies (US), RAKwireless (China), TheThings.io (Spain), Datacake (Germany), Milesight (China), LORIOT (Switzerland), Exosite (US), Orbiwise (Switzerland), Netmore Group (Sweden), and Radio Bridge Inc (US). These players have adopted various growth strategies, such as partnerships, agreements and collaborations, new product launches, enhancements, and acquisitions to expand their footprint in the LoRa and LoRaWAN IoT Market.
Browse Adjacent Markets: Digitalization and Internet of Things (IoT) Market Research Reports & Consulting
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The B2B economy is witnessing the emergence of $25 trillion of new revenue streams that are substituting existing revenue streams in this decade alone. We work with clients on growth programs, helping them monetize this $25 trillion opportunity through our service lines – TAM Expansion, Go-to-Market (GTM) Strategy to Execution, Market Share Gain, Account Enablement, and Thought Leadership Marketing.
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Artificial Intelligence
Scoring a Seat at UEFA EURO 2024™ with Top-Performing AI-Powered TOSHIBA TV Lineup
HONG KONG, June 14, 2024 /PRNewswire/ — Football fans are in for a treat as they gear up for UEFA EURO 2024™ with Toshiba TV’s top-performing Gaming TV Z670. As the OFFICIAL TV OF UEFA EURO 2024™, Toshiba TVs present immersive viewing of the football game by their AI-powered TV lineup. To celebrate the brilliant moments it can bring, Toshiba TV are gifting USD100 Amazon Gift Card via their social platform! By simply like, follow and comment on @ToshibaTVGlobal, fans can boost their chances of scoring this prize.
Optimized Visuals Tailored for Football Dynamics
The Toshiba REGZA Engine ZRi in Z670 transports football fans into the heart of the action. With the AI Football Mode, they’ll be able to see fast-moving objects crystal clear and football field actions much enriched. To see their favourite player score that winning goal, the AI Picture Optimizer automatically adjusts visual contrast and precision adapted to the game. From vivid green fields and vibrant player kits, every play comes to life with AI 4K Upscaling and Quantum Dot Color, transforming lower-resolution broadcasts into near-4K quality and unleashing lifelike visual color.
Powerful Audio Effects for a Live Stadium Experience
The Toshiba TV Z670’s powerful audio system makes viewers feel like they’re right in the game. With the REGZA Bass Woofer Pro, Tru Bass Booster, and Dolby Atmos, they’ll experience heart-thumping 3D surround sound that captures the live stadium atmosphere. Whether it’s the roar of the crowd or the intensity of each play, the rich audio brings the excitement of each game right into their room.
Bringing Everyone Together for UEFA EURO 2024™
Available in sizes ranging from 55″ to 85″, Z670 is equipped with a Wide Viewing Angle and Anti-reflection features that ensures a clear picture from all viewing positions with the non-glare panel. Gather everyone for “Brilliant Every Moment” in UEFA EURO 2024™ with Toshiba TV!
Please find the high-resolution TVC here: Link
About Toshiba TV:
With 70+ years of history in TV production, Toshiba TV is known for its exquisite craftsmanship, innovative ideas and groundbreaking inventions. By prioritizing superior image quality and auditory experiences, Toshiba TV sets new standards in entertainment. Toshiba TV stems from the excellence quest of customers, providing the world with responsible products to make the world a better place. Emphasizing attention to product details and technological advancement, Toshiba TV integrates aesthetically pleasing design, quality assurance, and brand reputation to underscore its commitment to authenticity in the actual world and a sincere dedication to its consumers, showcasing Toshiba TV’s long-standing design philosophy and continuous pursuit of product quality.
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