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Hepion Pharmaceuticals Announces Publication of Phase 2a ‘AMBITION’ Clinical Trial Results

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– Study met safety, tolerability, and pharmacokinetics primary endpoints –

– Reductions in ALT, ProC3, and C6M suggest direct antifibrotic effects with longer treatment duration –

– Enrollment initiated in Phase 2b ‘ASCEND-NASH’ trial evaluating the safety and efficacy of rencofilstat in 336 biopsy confirmed F2 / F3 NASH subjects –

EDISON, N.J., Oct. 26, 2022 (GLOBE NEWSWIRE) — Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of fibrotic diseases, including non-alcoholic steatohepatitis (“NASH”), hepatocellular carcinoma (“HCC”), and other chronic liver diseases, today announced that the peer-reviewed journal, Hepatology Communications, has published a paper by Harrison et al. entitled, “Rencofilstat, a cyclophilin inhibitor: A phase 2a, multicenter, single-blind, placebo-controlled study in F2/F3 NASH,” reviewing the results of Hepion’s ‘AMBITION’ clinical trial.

The Phase 2a, multicenter, single-blind, placebo-controlled study randomized 49 presumed F2/F3 NASH subjects to receive either 75 mg or 225 mg of rencofilstat, or placebo, once daily for 28 days. The aim of the study was to determine safety, tolerability, and pharmacokinetics, while exploring NASH efficacy biomarkers, including multi-omic and AI-POWR™ analyses.

As previously reported, the AMBITION clinical trial demonstrated rencofilstat was safe and well tolerated. A majority of subjects (28/47; 59.6%) who were dosed with rencofilstat, or placebo experienced no adverse events. Of the 36 adverse events recorded in total, 97.2% were graded as mild to moderate, none were serious, and the majority (27/36; 75%) were considered unrelated to administration of rencofilstat. Additionally, blood concentrations of rencofilstat in the NASH subjects were similar to those observed previously in healthy subjects.

The reductions in alanine transaminase (“ALT”), a biomarker of liver damage, were greater in the rencofilstat arms versus the placebo groups and was statistically different in the 225-mg cohort compared to the placebo cohort (−16.3 ± 25.5% versus −0.7 ± 13.4%, respectively). Reductions in Pro-C3, a biomarker of collagen formation and fibrosis, and C6M, a biomarker of tissue remodeling, were statistically significant in rencofilstat subjects with baseline Pro-C3 levels above 15.0 ng/mL. Pro-C3 levels greater than 15-20 ng/mL are generally accepted to represent active NASH disease and a marker of fibrosis in the primary patient population for treatment by many NASH drug candidates. The paper concluded that the reductions in ALT, Pro-C3, and C6M suggest that rencofilstat has direct antifibrotic effects with longer treatment duration, supporting the advancement of rencofilstat into a larger and longer Phase 2b study.

“The findings of this paper further strengthen the rationale behind our ongoing Phase 2b ‘ASCEND-NASH’ trial, which initiated screening at the end of August,” said Robert Foster, PharmD, PhD, CEO of Hepion. “The degree of decline in Pro-C3 observed in the AMBITION trial, which had a duration of only 28 days, was comparable to Pro-C3 declines seen in similar studies with durations of several months, particularly in subjects with Pro-C3 levels indicating more advanced disease. Given this observation, we are very much looking forward to seeing the magnitude of rencofilstat’s antifibrotic effects over a 12-month-period in our ongoing Phase 2b trial.”

The article may be accessed at: https://doi.org/10.1002/hep4.2100.

About Hepion Pharmaceuticals

The Company’s lead drug candidate, rencofilstat, is a potent inhibitor of cyclophilins, which are involved in many disease processes. Rencofilstat 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. Rencofilstat 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. In November 2021, the U.S. Food and Drug Administration (“FDA”) granted Fast Track designation for rencofilstat for the treatment of NASH. That was followed in June 2022 by the FDA’s granting of Orphan Drug designation to rencofilstat for the treatment of HCC.

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 rencofilstat, potentially shortening development timelines and increasing the delta between placebo and treatment groups. In addition to using AI-POWR™ to drive its ongoing NASH clinical development program, Hepion intends to use the platform to identify additional potential indications for rencofilstat 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, 2021, 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]  

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Artificial Intelligence

Dubai World Trade Centre Drives Impact as Economic Output Surges to US$4.98 Billion in 2023, up 40% YoY

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DUBAI, UAE, May 20, 2024 /PRNewswire/ — Dubai World Trade Centre (DWTC), a global leader in the events and exhibitions industry, has once again demonstrated its significant impact on Dubai’s economy in 2023, welcoming 2.47 million participants and hosting 301 events, 76 of which, were large-scale events that attracted 1.54 million attendees, with 46% from overseas.

DWTC’s 2023 Economic Impact Assessment (EIA) Report, based on its 76 large-scale events (2000 or more attendees) revealed an impressive surge in the total economic output, reaching US$4.98 billion, marking an incredible 40% YoY increase, with high returns for adjacent industries such as Travel, Accommodation and Retail, connected to the Meetings Incentives Conferences and Exhibitions (MICE) ecosystem.
DWTC’s large-scale events generated a substantial US$2.87 billion Gross Value Added (GVA) to Dubai’s GDP, retaining an impressive 58% of the total economic output locally. International participation soared by 53%, with overseas visitors driving 6.2 times more contribution than domestic counterparts.
Events hosted at DWTC supported 69,281 jobs, generating US$915 million in disposable household income for the city’s residents. The substantial economic impact of these events extends beyond direct revenue generation, fostering socio-economic development and contributing to Dubai’s status as a leading global business hub.
His Excellency Helal Saeed Almarri, Director General of DWTC Authority, said: “Aligned with Dubai’s Economic Agenda D33, we continue to spearhead efforts in sector diversification, reinforcing the city’s stature as a leading global business hub. The remarkable accomplishments of 2023, presented in the ‘DWTC Economic Impact Assessment Report’ demonstrate that Dubai’s MICE sector, driven by DWTC, remains a vital pillar of financial resilience and growth underscoring our accelerated strides towards sustainable socio-economic development. The increase in international participation, along with the significant economic impact generated across diverse sectors such as travel, accommodation and retail, highlights the city’s steadfast commitment to propelling business tourism.”
The venue’s formidable events portfolio strategically aligned with Dubai’s economic priorities, showcasing Healthcare, Medical, and Scientific; Information Technology (IT); and Food, Hotel, and Catering as the top contributors. These leading sectors collectively accounted for 59% (US$1.71 billion) of the GVA to Dubai’s economy, and 49% (747,468) of the total large-scale event visitation.
Adjacent sectors, including hotels, air travel, and local transportation experienced a significant boost in economic activity. The direct revenue generated through expenditure was nearly US$2.94 billion.
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Aramco signs agreement with Pasqal to deploy first quantum computer in the Kingdom of Saudi Arabia

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DHAHRAN, Saudi Arabia, May 20, 2024 /PRNewswire/ — Aramco, one of the world’s leading integrated energy and chemicals companies, has signed an agreement with Pasqal, a global leader in neutral atom quantum computing, to install the first quantum computer in the Kingdom of Saudi Arabia.

The agreement will see Pasqal install, maintain, and operate a 200-qubit quantum computer, which is scheduled for deployment in the second half of 2025.
Ahmad Al-Khowaiter, Aramco EVP of Technology & Innovation, said: “Aramco is delighted to partner with Pasqal to bring cutting-edge, high-performance quantum computing capabilities to the Kingdom. In a rapidly evolving digital landscape, we believe it is crucial to seize opportunities presented by new, impactful technologies and we aim to pioneer the use of quantum computing in the energy sector. Our agreement with Pasqal allows us to harness the expertise of a leading player in this field, as we continue to build state-of-the-art solutions into our business. It is also further evidence of our contribution to the growth of the digital economy in Saudi Arabia.”
Georges-Olivier Reymond, Pasqal CEO & Co-founder, said: “The era of quantum computing is here. No longer confined to theory, it’s transitioning to real-world applications, empowering organisations to solve previously intractable problems at scale. Since launching Pasqal in 2019, we have directed our efforts towards concrete quantum computing algorithms immediately applicable to customer use cases. Through this agreement, we’ll be at the forefront of accelerating commercial adoption of this transformative technology in Saudi Arabia.  This isn’t just any quantum computer; it will be the most powerful tool deployed for industrial usages, unlocking a new era of innovation for businesses and society.”
The quantum computer will initially use an approach called “analog mode.” Within the following year, the system will be upgraded to a more advanced hybrid “analog-digital mode,” which is more powerful and able to solve even more complex problems.
Pasqal and Aramco intend to leverage the quantum computer to identify new use cases, and have an ambitious vision to establish a powerhouse for quantum research within Saudi Arabia. This would involve leading academic institutions with the aim of fostering breakthroughs in quantum algorithm development — a crucial step for unlocking the true potential of quantum computing.
The agreement also accelerates Pasqal’s activity in Saudi Arabia, having established an office in the Kingdom in 2023, and follows the signing of a Memorandum of Understanding between the companies in 2022 to collaborate on quantum computing capabilities and applications in the energy sector. In 2023, Aramco’s Wa’ed Ventures also participated in Pasqal’s Series B fundraising round.
About Aramco
Aramco is a global integrated energy and chemicals company. We are driven by our core belief that energy is opportunity. From producing approximately one in every eight barrels of the world’s oil supply to developing new energy technologies, our global team is dedicated to creating impact in all that we do. We focus on making our resources more dependable, more sustainable and more useful. This helps promote stability and long-term growth around the world. www.aramco.com 
About PASQAL
Pasqal is a leading Quantum Computing company that builds quantum processors from ordered neutral atoms in 2D and 3D arrays to bring a practical quantum advantage to its customers and address real-world problems. Pasqal was founded in 2019, out of the Institut d’Optique, by Georges-Olivier Reymond, Christophe Jurczak, Professor Dr. Alain Aspect – Nobel Prize Laureate Physics, 2022, Dr. Antoine Browaeys and Dr. Thierry Lahaye. Pasqal has secured more than €140 million in financing to date. To learn more about Pasqal, visit www.pasqal.com.
Disclaimer
The press release contains forward-looking statements. All statements other than statements relating to historical or current facts included in the press release are forward-looking statements. Forward-looking statements give the Company’s current expectations and projections relating to its capital expenditures and investments, major projects, upstream and downstream performance, including relative to peers. These statements may include, without limitation, any statements preceded by, followed by or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “can have,” “likely,” “should,” “could,” and other words and terms of similar meaning or the negative thereof. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors beyond the Company’s control that could cause the Company’s actual results, performance or achievements to be materially different from the expected results, performance, or achievements expressed or implied by such forward-looking statements, including the following factors: global supply, demand and price fluctuations of oil, gas and petrochemicals; global economic conditions; competition in the industries in which Saudi Aramco operates; climate change concerns, weather conditions and related impacts on the global demand for hydrocarbons and hydrocarbon-based products; risks related to Saudi Aramco’s ability to successfully meet its ESG targets, including its failure to fully meet its GHG emissions reduction targets by 2050; conditions affecting the transportation of products; operational risk and hazards common in the oil and gas, refining and petrochemicals industries; the cyclical nature of the oil and gas, refining and petrochemicals industries; political and social instability and unrest and actual or potential armed conflicts in the MENA region and other areas; natural disasters and public health pandemics or epidemics; the management of Saudi Aramco’s growth; the management of the Company’s subsidiaries, joint operations, joint ventures, associates and entities in which it holds a minority interest; Saudi Aramco’s exposure to inflation, interest rate risk and foreign exchange risk; risks related to operating in a regulated industry and changes to oil, gas, environmental or other regulations that impact the industries in which Saudi Aramco operates; legal proceedings, international trade matters, and other disputes or agreements; and other risks and uncertainties that could cause actual results to differ from the forward-looking statements in this press release, as set forth in the Company’s latest periodic reports filed with the Saudi Stock Exchange. For additional information on the potential risks and uncertainties that could cause actual results to differ from the results predicted please see the Company’s latest periodic reports filed with the Saudi Stock Exchange. Such forward-looking statements are based on numerous assumptions regarding the Company’s present and future business strategies and the environment in which it will operate in the future. The information contained in the press release, including but not limited to forward-looking statements, applies only as of the date of this press release and is not intended to give any assurances as to future results. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to the press release, including any financial data or forward-looking statements, whether as a result of new information, future events or otherwise, unless required by applicable law or regulation. No person should construe the press release as financial, tax or investment advice. Undue reliance should not be placed on the forward-looking statements.
Aramco Contact Information:
  @aramco

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Compact Solutions, Mighty Results: Cervoz Unleashes the Power of Edge Computing

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TAIPEI, May 20, 2024 /PRNewswire/ — Cervoz Technology, a leader in industrial-grade storage, memory, and expansion solutions, is powering the evolution of edge computing with its innovative solutions.

In today’s data-rich landscape, businesses rely on insights from IoT devices. With advancements in AI and 5G, data volumes surge, straining traditional cloud computing with bandwidth and latency issues. Edge Computing emerges as a solution, processing data at its source for real-time insights crucial for applications like digital twins, autonomous vehicles, and smart healthcare.
What is Edge Computing?
Edge Computing is a decentralized IT architecture that processes data near its origin, often at the network’s edge. This approach divides tasks from central data centers to edge devices and nodes. It enables faster, deeper insights and enhances responsiveness, improving speed and reducing latency compared to centralized clouds. Typically, an Edge Computing system comprises three layers: device, edge, and cloud.
The Device Layer
The device layer, situated closest to the physical world, comprises endpoint devices such as sensors, controllers, and cameras, among others. The layer prioritizes data collection and initial processing for real-time response and efficiency. It requires highly reliable, compact, and energy-efficient components. Cervoz’s M.2 2230 (A+E key /B+M key) NVMe SSDs and DDR4 SO-DIMM modules optimize this setup with fast data access and efficient storage in space-saving designs. They operate reliably across a wide temperature range (-40°C to 85°C) and feature additional conformal coating and anti-vibration filling for enhanced performance in harsh environments.
The Edge Layer
The edge layer, composed of edge servers and gateways, serves as a crucial link between device-layer data sources and cloud-based operations. It is designed for extensive data handling, filtering, and analytics, emphasizing quick operations and real-time responses to minimize reliance on remote data centers. For optimal performance, components must manage high processing loads with minimal latency and maximum stability. NVMe SSDs boasting PCIe Gen3 or higher, such as the Cervoz NVMe PCIe Gen3x4 SSD, with compact M.2 form factors, advanced DRAM cache buffer, and LDPC ECC technology, are perfectly suited for the edge layer. These SSDs enable efficient directory and error correction during high-speed data transfers, thus enhancing data accuracy and reliability.
The Cloud Layer
The cloud layer requires intensive processing and long-term storage, performing analytics, operating AI and machine learning, and managing extensive data systems across various edge locations. It demands high-performing and reliable components. Cervoz NVMe PCIe Gen4x4 SSDs excel with Read/Write speeds of up to 7,100/6,190 MB/s and 4K random IOPS up to 1,000K, with aluminum heatsinks and thermal throttling for overheating issues. DDR5-5600 DRAM boosts this setup with high data throughput and efficient power use, satisfying rigorous computational needs.
Interlayer Connectivity
Reliable, low-latency network connectivity is crucial as data flows between the device layer, edge, and cloud. Cervoz 10GbE Low-Profile Ethernet Card provides high-speed, stable wired connections in high-bandwidth, low-latency environments. Additionally, the new PCIe Compact Low-Profile Ethernet Card is ideal for narrow edge device enclosures. For areas where wiring is impractical, M.2 Wi-Fi cards offer essential wireless flexibility. These connectivity options ensure a solid foundation for seamless data management across all layers.
Cervoz offers comprehensive solutions to enhance edge computing capabilities. From compact NVMe SSDs and DRAM modules, to advanced modular expansion cards, enabling seamless integration, optimized performance, and unmatched reliability in edge computing deployments.
About Cervoz
Based in Taiwan, Cervoz Technology boasts almost twenty years of expertise in developing and providing industrial-grade storage, memory, and expansion solutions across a myriad of global industrial sectors.
ContactsSales: [email protected] 
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