Artificial Intelligence
DIAMOND Mouse Model is Latest in a String of Nonclinical Studies Confirming the Antifibrotic Effects of Hepion Pharmaceutical’s Lead Drug, CRV431
EDISON, N.J., March 23, 2021 (GLOBE NEWSWIRE) — Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA, “Hepion”), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”) – driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”) and liver disease, today announced positive results from an in vivo study of CRV431 in a Diet-Induced Animal Model Of Non-alcoholic fatty liver Disease (“DIAMOND”).1
It is estimated by the National Institutes of Health, that between 3% – 12% of the U.S. adult population has NASH.2 There are currently at least 90 drug candidates targeting NASH in various stages of development.3 The majority of these drug candidates are designed to target metabolic perturbations leading to the pathogenesis of NASH and thereby seek to normalize glycemic control, lipid metabolism, and insulin resistance, to name a few. Few drug candidates directly target fibrosis, either through fibrogenesis and/or fibrolysis, despite fibrosis being a major prognostic indicator of liver-related and overall mortality.4 Hepion’s clinical drug candidate, CRV431 administered once daily orally, seeks to target fibrosis, and the company’s latest in vivo animal study further lends validity to this mechanism.
“Nonclinical animal efficacy models have been designed to recapitulate human disease. However, questions remain regarding the validity of these models and whether they are truly predictive of clinical efficacy outcomes,” commented Dr. Daren Ure, Hepion’s Chief Scientific Officer. “This uncertainty can be partly alleviated by performing nonclinical studies in many different types of experimental models to test the robustness of a drug’s effects. For this reason, we have conducted 9 individual animal studies of fibrosis and found consistent and statistically significant antifibrotic effects of CRV431 in every one of these studies. Antifibrotic activity has also been observed in previously reported studies conducted by an independent U.K. laboratory that studied explanted liver and lung tissues taken from human donors. Taken together, these animal and human tissue experiments give us a great deal of confidence that CRV431 has beneficial antifibrotic effects that are expected to be borne out clinically.”
“The results obtained with the DIAMOND mouse experiment confirm, once again, that CRV431 is a potent antifibrotic agent,” commented Dr. Philippe Gallay, Professor of Immunology, at the Scripps Research Institute in San Diego. “This model of NASH was originally developed by Dr. Arun Sanyal, a global leader in the development and treatment of therapies for NASH. In this study, our laboratory established NASH by feeding animals with a fat- and sugar-enriched Western diet for 34 weeks, followed by 8 weeks treatment with oral dosing of CRV431 or two comparator drugs, obeticholic acid and elafibranor. Fibrosis was reduced, as determined using Picrosirius Red staining, by 47% with CRV431, 35% with obeticholic acid, and 37% with elafibranor, relative to vehicle controls. A 47% reduction in fibrosis with CRV431 is an incredible result, and this highlights that a relatively short course of CRV431 treatment can exert beneficial effects at an advanced stage of liver disease in a model having many similarities to human NASH.”
A summary of CRV431’s nonclinical in vivo antifibrotic activity is shown in the following table:
| Model | Oral Dose (animal) |
Dosing Duration | Fibrosis Reduction (Organ) | Statistical Significance |
| DIAMOND | 50 mg/kg (mouse) |
8 weeks | 47% (liver) | Significant p<0.0001 |
| Streptozotocin (“STAM”) plus High Fat Diet (“HFD”) | 20 mg/kg (mouse) |
3 weeks | 57% (liver) | Significant p<0.01 |
| STAM plus HFD | 50 mg/kg (mouse) |
6 weeks | 46% (liver) | Significant p=0.03 |
| STAM plus HFD | 50 mg/kg (mouse) |
11 weeks | 37% (liver) | Significant p=0.01 |
| STAM plus HFD | 50 mg/kg (mouse) |
10 weeks | 44% (liver) | Significant p=0.014 |
| Western Diet + CCl4 | 50 mg/kg (mouse) |
6 weeks | 82% (liver) | Significant p<0.0001 |
| Thioacetamide | 40 mg/kg (rat) |
9 weeks | 48% (liver) | Significant p=0.008 |
| CCl4 | 50mg/kg (mouse) |
6 weeks | 43% (liver) | Significant p=0.005 |
| Unilateral Ureteral Obstruction | 50 mg/kg (mouse) |
2 weeks | 42% (kidney) | Significant p=0.0006 |
Dr. Patrick Mayo, Hepion’s Senior Vice-President, Clinical Pharmacology and Analytics continued, “As previously reported, we have completed the 75 mg dosing cohort with CRV431 in our ongoing Phase 2a clinical study in NASH subjects, and recruitment is continuing for the 225 mg dosing cohort. While this 28-day trial is focused on the safety and pharmacokinetics of CRV431, the data show that 75 mg CRV431 dosing decreased serum transaminases (ALT, AST) from baseline, consistent with a beneficial effect on the liver. Histologic changes are not being evaluated in this study due to the short duration of treatment, but additional evidence of therapeutic effects is being sought from an extensive multi-omics program. Thousands of genes, proteins, and lipids from patients are being monitored and analyzed with Hepion’s AI-POWR™ platform to look for potential biomarkers and early signs of CRV431 efficacy that may translate to structural and functional improvements to patient livers over the longer term. Similar multi-omic studies in DIAMOND and other nonclinical models help to strengthen predictions to apply to future clinical studies.”
“Overall, this is all about helping patients and developing a comprehensive risk mitigation strategy in our drug development program,” commented Dr. Robert Foster, Hepion’s Chief Executive Officer. “We know that drug development is expensive, time-consuming, and risky. Broadly speaking, companies like Hepion are faced with two major risk hurdles – drug development risk and financing risk. We recently significantly mitigated our financing risk via a successful public offering, and now we believe we are helping reduce our clinical development risk by employing numerous nonclinical efficacy models, including the recent DIAMOND model, human explanted liver tissues, and our proprietary AI.”
Dr. Foster concluded, “We are relying on the expertise of our highly experienced team to effectively use all available tools to maximize the chances of CRV431’s clinical success. In that regard, we look forward to the top-line read-out of our Phase 2a NASH study in the near future.”
1 https://doi.org/10.1016/j.jhep.2016.05.005
2 Bell, J. No one knows the size of the NASH market. BioPharma Dive. https://www.biopharmadive.com/news/no-one-knows-the-size-of-the-nash-market/554240/ (2019).
3 Nonalcoholic Steatohepatitis Drug Pipeline Analysis Review, 2020. DelveInsight Business Research LLP.
4Taylor, R.S.; Taylor, R.J.; Bayliss, S., et al. Association Between Fibrosis Stage and Outcomes of Patients with Nonalcoholic Fatty Liver Disease: A Systematic Review and Meta-Analysis. Gastroenterology, 2020, 158(6):1611-1625.
About Hepion Pharmaceuticals
The Company’s lead drug candidate, CRV431, is a potent inhibitor of cyclophilins, which are involved in many disease processes. CRV431 is currently in clinical-phase development for the treatment of NASH, with the potential to play an important role in the overall treatment of liver disease – from triggering events through to end-stage disease. CRV431 has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH; and has demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms, in nonclinical studies.
Hepion has created a proprietary AI platform, called AI-POWR™, which stands for Artificial Intelligence – Precision Medicine; Omics (including genomics, proteomics, metabolomics, transcriptomics, and lipidomics); World database access; and Response and clinical outcomes. Hepion intends to use AI-POWR™ to help identify which NASH patients will best respond to CRV431, potentially shortening development timelines and increasing the delta between placebo and treatment groups. In addition to using AI-POWR™ to drive its ongoing Phase 2a NASH program, Hepion will use the platform to identify additional potential indications for CRV431 to expand the company’s footprint in the cyclophilin inhibition therapeutic space.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated,” and “intend,” among others. These forward-looking statements are based on Hepion Pharmaceuticals’ current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals’ Form 10-K for the year ended December 31, 2019 and other periodic reports filed with the Securities and Exchange Commission.
For further information, please contact:
Stephen Kilmer
Hepion Pharmaceuticals Investor Relations
Direct: (646) 274-3580
[email protected]
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.
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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.
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Artificial Intelligence
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