Phanar Legal and Sylla & Partners Advise State of Guinea on $14bn Project to Develop the World’s Largest Undeveloped Iron Ore Deposit.

 LONDON & CONAKRY, Guinea-Wednesday 2 December 2020 [ AETOS Wire ]

(BUSINESS WIRE) -- Boutique law firms Phanar Legal (London) and Sylla & Partners (Conakry) have jointly advised the State of Guinea on the $14 billion Simandou North project. The project is the largest mine and infrastructure project across the African continent which will unlock the potential of the world’s largest undeveloped iron ore deposit.

Phanar Legal and Sylla & Partners have provided ongoing integrated counsel to the State of Guinea to form a legal framework for the Simandou North project, culminating in the negotiation and conclusion of a mining agreement signed on 8 June 2020; as well as rail and port agreements signed on 12 November 2020.

The agreements pave the way for the construction of a 650km Trans-Guinean railway and a new coastal port with an estimated annual production capacity at 100 MTPA. The project will act as a catalyst for economic development along the railway corridor, particularly in the agricultural sector where is it expected to generate significant job opportunities.

Phanar Legal and Sylla & Partners will now seek a merger of equals to further capitalise on the emerging opportunities for law firms in Africa and Europe to collaborate on an equal footing as more African nations seek to accelerate their economic development.

Philip Rogers, Senior Partner at Phanar Legal, commented:

“This is project is truly transformational and it is a privilege to have been a part of it. We have been involved from devising and organising the tender through to signing the project documents comprising a mining convention, rail convention and port convention. It is a tribute to both the Republic of Guinea and SMB-Winning to have been able to conclude such complex negotiations during the COVID-19 pandemic.”

Mohamed Sylla, Managing Partner at Sylla & Partners, commented:

“This project will help to change the lives of future generations and I am very proud that we have supported the Government of Guinea. The vision, energy and inspiration of the President and Mining Minister, and the dedication of officials in the Mining Ministry, have brought about this transformational deal. The SMB-Winning consortium is also to be applauded for the constructive approach they have adopted throughout the process.”

View source version on businesswire.com: https://www.businesswire.com/news/home/20201201006224/en/

Contacts

For More Information:

Philip Rogers, Senior Partner, Phanar Legal

Philip.rogers@phanarlegal.com

http://www.phanarlegal.com

Mohamed Sidiki Sylla, Managing Partner, Sylla & Partners

msylla@syllapartners.com

https://www.syllapartners.com/

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Market Access Transformation (MAT) Secures First Institutional Funding Led by Silversmith Capital Partners

 SHORT HILLS, N.J.-Wednesday 2 December 2020 [ AETOS Wire ]

(BUSINESS WIRE)-- Market Access Transformation (MAT), a global healthcare company that uses cutting edge technology to automate and modernize how life sciences companies capture mission-critical insights that drive decision-making across the product lifecycle, today announced a $30 million minority investment from Silversmith Capital Partners, a Boston-based growth equity firm. The investment marks the first time MAT has raised outside capital and will be used to expand the company’s team and accelerate innovation of its product offerings.

Founded in 2016, MAT has revolutionized the way Global Payer Market Research is conducted by developing Rapid Payer Response (RPR), the industry’s only on-demand global platform for gathering critical payer insights. In five years, the company has built a client base of more than 45 biopharma and device manufacturers – including all of the Top 10 pharma companies. MAT’s partnership with Silversmith solidifies its market leadership position in providing technology-driven solutions to the healthcare community.

“Providing our clients with new and improved offerings that address unmet needs within healthcare research and analytics has been our primary focus since we started MAT,” said Baiju Aurora, MAT’s CEO and Co-Founder, who along with Co-Founder Paul Howard will continue to lead the company. “We are incredibly proud of what our team has achieved in such a short period of time and are excited to partner with Silversmith as we look to accelerate our product development initiatives.”

RPR is built on the company’s proprietary SaaS platform that enables manufacturers to obtain more robust insights, in 1/3 the time and 1/2 the cost of more traditional, manual-based approaches. RPR is powered by an expansive global payer network – which spans over 40 countries – and leverages a unique payer selection and vetting process. “While RPR has enabled us to deliver technology solutions to a wide variety of pharma companies across the globe, our expert team of pricing and market access specialists drive client engagement and satisfaction,” added Paul Howard.

“One of the biggest challenges life sciences organizations face is gathering payer insights in an agile manner to drive optimal clinical and commercial product strategies as regulatory and market dynamics evolve,” said Brian Peterson, Principal of Silversmith. “What impressed us most about MAT was their platform’s ability to deliver insights in days instead of months, while maintaining industry-leading quality on a global scale. We are thrilled to partner with Baiju, Paul and the entire MAT team, and look forward to working with them as they continue to bring innovative offerings to the market.”

As part of the investment, Brian Peterson and Jim Quagliaroli, Managing Partner of Silversmith, have joined MAT’s Board of Directors, along with Baiju Aurora and Paul Howard.

Choate, Hall & Stewart served as legal counsel to Silversmith Capital Partners and Day Pitney served as legal counsel to MAT.

About Market Access Transformation

With offices in the US, UK, and India, Market Access Transformation specializes in developing cutting edge technologies that enable the healthcare community to gather and exchange insights that assess the real-world potential of their products. MAT’s first product, Rapid Payer Response™ (RPR), is an online platform-based information exchange that allows healthcare manufacturers to secure On-Demand expert insight from the largest and most diverse global payer network in as little as 5 days. For more information about MAT, please visit www.marketaccesstransformation.com.

About Silversmith Capital Partners

Founded in 2015, Silversmith Capital Partners is a Boston-based growth equity firm with $2.0 billion of capital under management. Silversmith’s mission is to partner with and support the best entrepreneurs in growing, profitable technology and healthcare companies. Representative investments include ActiveCampaign, Appfire, Centauri Health Solutions, DistroKid, Impact, LifeStance Health, MediQuant, Panalgo, Unily, Validity, and Webflow. The partners have over 75 years of collective investing experience and have served on the boards of numerous successful growth companies including ABILITY Network, Archer Technologies, Dealer.com, Liazon, Liberty Dialysis, MedHOK, Net Health, Passport Health, SurveyMonkey, and Wrike. For more information about Silversmith, please visit www.silversmith.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201201005187/en/

Contacts

Kate Castle

Silversmith Capital Partners

P: 617.670.4345

kate@silversmithcapital.com

Permalink : https://www.aetoswire.com/news/market-access-transformation-mat-secures-first-institutional-funding-led-by-silversmith-capital-partners/en

Velodyne Lidar Announces Autonomous Driving Collaboration with Ford Otosan

 Companies Working Together on Autonomous Driving Development and Testing for Heavy Commercial Vehicles

SAN JOSE, Calif.-Wednesday 2 December 2020 [ AETOS Wire ]

(BUSINESS WIRE)-- Velodyne Lidar, Inc. (Nasdaq: VLDR) today announced it is collaborating with Ford Otosan on product development and testing of autonomous heavy commercial trucks. Ford Otosan is testing and planning to use Velodyne Velarray H800 lidar sensors to enable safe navigation and collision avoidance in next generation vehicles.

Velarray H800 is a powerful solution that can greatly improve automated safety and advanced driver assistance systems (ADAS). Designed for automotive-grade performance and durability, the Velarray H800’s compact, embeddable form factor makes it ideal for seamless integration in internal and external vehicle mounting locations.

The Velarray H800 boasts outstanding range, field of view and resolution to deliver rich point cloud density required for high resolution mapping and object classification tasks. The sensor will help Ford Otosan to create superior autonomous driving technology, addressing edge-cases for driving situations, including curvy roads, potholes, intersections, on/off ramps, residential areas and roadways with unclear lane markings. It delivers high performance during daylight and at night, enabling the detection of vehicles, pedestrians, bicyclists, motorcyclists and more.

Ford Otosan is already using Velodyne’s Alpha Prime™ lidar sensors, which provide 360-degree surround-view perception technology to support autonomous mobility. The Alpha Prime is specifically made for autonomous driving in complex conditions for travel up to highway speeds. The combined range, resolution and field of view in one sensor is designed to enable autonomous vehicles and ADAS in a wide variety of lighting conditions.

“Autonomous vehicle technology, powered by lidar, can bring multiple efficiency and safety benefits to the trucking industry,” said Burak Gökçelik, Assistant General Manager, Ford Otosan. “Our autonomous driving initiative with Velodyne looks to improve roadway safety by helping trucks understand and react to approaching road conditions and surroundings.”

“Ford Otosan has well established commercial vehicle leadership in Europe and they act as the global engineering center for Ford Motor Company’s heavy commercial vehicles,” said Erich Smidt, Executive Director Europe, Velodyne Lidar. “We look forward to cooperating with Ford Otosan on autonomous driving development and learning from their use of the Velarray H800 in the trucking market.”

About Velodyne Lidar

Velodyne Lidar (NASDAQ: VLDR) ushered in a new era of autonomous technology with the invention of real-time surround view lidar sensors. Velodyne is the first public pure-play lidar company and is known worldwide for its broad portfolio of breakthrough lidar technologies. Velodyne’s revolutionary sensor and software solutions provide flexibility, quality and performance to meet the needs of a wide range of industries, including autonomous vehicles, advanced driver assistance systems (ADAS), robotics, unmanned aerial vehicles (UAV), smart cities and security. Through continuous innovation, Velodyne strives to transform lives and communities by advancing safer mobility for all. For more information, visit www.velodynelidar.com.

About Ford Otosan

Ford Otosan, with its annual production capacity of 455,000 vehicles, 70,000 engines and 140,000 powertrains, is the biggest commercial vehicle production center of Ford in Europe. The company produces and develops Transit & Tourneo range commercial vehicles, and also serves as the global engineering & production center for Ford Trucks heavy commercial vehicles and their engine systems. The company has all the capabilities and infrastructure required to design, develop, and test a whole vehicle, including its engine, from scratch to the complete commercial product. Ford Otosan (Ford Otomotiv Sanayi A.Ş.) is a publicly traded company, where Ford Motor Company and Koç Holding have equal shares. For more information, visit https://www.fordotosan.com.tr/en

Forward Looking Statements

This press release contains "forward looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995 including, without limitation, all statements other than historical fact and include, without limitation, statements regarding Velodyne’s target markets, new products, development efforts, competition. When used in this press release, the words "estimates," "projected," "expects," "anticipates," "forecasts," "plans," "intends," "believes," "seeks," "may," "will," "should," "future," "propose" and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside Velodyne's control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. Important factors, among others, that may affect actual results or outcomes include Velodyne's ability to manage growth; Velodyne's ability to execute its business plan; uncertainties related to the ability of Velodyne's customers to commercialize their products and the ultimate market acceptance of these products; the uncertain impact of the COVID-19 pandemic on Velodyne's and its customers' businesses; uncertainties related to Velodyne's estimates of the size of the markets for its products; the rate and degree of market acceptance of Velodyne's products; the success of other competing lidar and sensor-related products and services that exist or may become available; Velodyne's ability to identify and integrate acquisitions; uncertainties related to Velodyne's current litigation and potential litigation involving Velodyne or the validity or enforceability of Velodyne's intellectual property; and general economic and market conditions impacting demand for Velodyne's products and services. Velodyne undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201201005505/en/

Contacts

Landis Communications Inc.

Sean Dowdall

(415) 286-7121

velodyne@landispr.com

Permalink : https://www.aetoswire.com/news/velodyne-lidar-announces-autonomous-driving-collaboration-with-ford-otosan/en

iRhythm Technologies Receives Positive National Guidance in First of its Kind Digital Health Pilot with National Institute for Health and Care Excellence

 Remote cardiac monitoring service Zio XT has been evaluated and positively recommended by NICE

SAN FRANCISCO & LONDON-Tuesday 1 December 2020 [ AETOS Wire ]

(BUSINESS WIRE)-- iRhythm Technologies (NASDAQ: IRTC), a leading digital health care solutions company focused on the advancement of cardiac care, today announced it is the first technology to pass through a new digital health tech pilot, resulting in a successful recommendation for adoption from the National Institute for Health and Care Excellence (NICE).

iRhythm’s Zio XT Service – a patient-friendly ambulatory cardiac monitor supported by deep learning algorithms – has been assessed as part of NICE’s first pilot project to evaluate digital health technologies. Zio XT has been positively recommended by NICE as an option for people with suspected cardiac arrhythmias who would benefit from ECG monitoring for longer than 24 hours.

Published today, the guidance concluded that Zio XT is convenient and easy to wear, with greater patient compliance and improved diagnostic yield (a measure of how many people with cardiac arrhythmias are diagnosed) compared with standard 24-hour Holter monitoring. Clinical evidence showed that patients preferred Zio XT compared to current monitoring practice in the NHS, which usually involves wearing a continuous ECG monitor, such as the 24-hour Holter monitor. Estimates also suggest that using Zio XT is likely to be cost saving, or cost the same as using 24-hour Holter monitoring.

Commenting on the news, Justin Hall, GM and VP EMEA at iRhythm said, “We are delighted that Zio has received such positive guidance from NICE in this first of its kind evaluation, especially at such a critical time. Throughout the COVID-19 pandemic we have seen a number of cardiac patients avoiding hospitals and suffering in silence, even when experiencing serious conditions such as strokes. This has led to a backlog of patients requiring care, putting additional pressure on medical staff and services.”

“Fortunately, services like Zio can help ease this backlog, offering clinically-validated services remotely. Patients are not required to expose themselves to high-risk hospital environments, while staff can still offer the same continued level of care. It’s critical, therefore, that patients have access to these technologies and for clinicians to be able to implement them quickly and easily.”

The guidance, which evaluates new, innovative medical devices and diagnostics, aims to help people in the NHS make efficient, cost-effective and consistent decisions about adopting new medical technologies. A positive NICE Medical Technologies Guidance opens the door for future support of the Zio service through the MedTech Funding Mandate, which aims to help accelerate the uptake of proven affordable innovations as part of the NHS Long Term Plan.

iRhythm’s positive recommendation from the NICE digital health pilot builds on the company’s recent win of the UK government’s AI in Health and Care Award, in which iRhythm will utilise the funding to evaluate its Zio service in selected NHS sites across the UK. Throughout the three-year programme, clinical, pathway and economic outcomes will be monitored and evaluated in order to inform any future commissioning decisions around the adoption of Zio within the NHS.

About iRhythm Technologies, Inc.

iRhythm is a leading digital health care company redefining the way cardiac arrhythmias are clinically diagnosed. The company combines wearable biosensor devices worn for up to 14 days and cloud-based data analytics with powerful proprietary algorithms that distil data from millions of heartbeats into clinically actionable information. The company believes improvements in arrhythmia detection and characterization have the potential to change clinical management of patients.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201201005522/en/

Contacts

Media Contacts:

Ellie Stansfield

Hotwire for iRhythm Technologies

irhythmuk@hotwireglobal.com

Saige Smith

HighwirePR for iRhythm Technologies

irhythm@highwirepr.com

Investor Relations Contact:

Leigh Salvo

Gilmartin Group

investors@irhythmtech.com

Permalink : https://www.aetoswire.com/news/irhythm-technologies-receives-positive-national-guidance-in-first-of-its-kind-digital-health-pilot-with-national-institute-for-health-and-care-excellence/en

beCloud Selects P.I. Works to Drive Automation of its Nationwide Multi-Operator and Multi-Vendor LTE Network

 Belarus’ telecommunications infrastructure provider, beCloud, has deployed P.I. Works’ EXA (Network Automation) and VantagePM (Performance Management) products to transform its nationwide 4G network

MINSK, Belarus-Tuesday 1 December 2020 [ AETOS Wire ]

(BUSINESS WIRE)-- beCloud, Belarus’ telecommunications infrastructure and service provider, has selected P.I. Works’ cutting-edge network management solutions to drive the automation and proactive monitoring of its multi-operator and multi-vendor 4G network.

The deployment has been initiated and will oversee the installation of P.I. Works’ next-generation automation and analytics products, EXA and VantagePM, to enable AI-powered network automation for 24/7 optimization across the operator’s networks. EXA, which runs on the P.I. Works EVO Platform™, will empower beCloud to automatically manage its traffic load, identify cross connection problems without visiting the sites and maximize 4G coverage using existing resources.

VantagePM, on the other hand, will enable beCloud to gauge insights into different operator users, monitor individual operator service quality levels, perform rigorous anomaly detection and implement easy-to-use interactive dashboards. To deliver this, P.I. Works utilizes PLMN (network country and operator codes) level filtering methods to segregate KPIs from different operators and to analyse each operator’s network separately. This serves as a fundamental functionality to beCloud, who is the principal provider of LTE Advanced services to all of Belarus mobile operators.

Mikhail Duka, Deputy General Director for Telecommunications at beCloud, said: “As of now, more than 87% of the Belarusian population are enjoying high-speed 4G connectivity, all thanks to our countrywide LTE Advanced infrastructure. We aim to provide top-class customer experience to all nation, and we are confident that our partnership with P.I. Works will be pivotal in achieving our goal, and fundamental to enhancing our service quality while reducing operational efforts through the integration of 24/7, centralized automation.”

Djakhongir Siradjev, Engineering Director at P.I. Works, said: “Our ability to cater for beCloud’s complex networks today, is a testament to the success of our multi-operator and multi-vendor network management & automation products. We strongly believe that our cloud-native EVO Platform with its built-in AI functionality will help to ensure the best customer experience, while maximizing existing investment utilization at minimum operational costs. We envisage that this partnership will serve beCloud’s customer experience goals, and therefore we are delighted to be a part of this exciting journey.”

About

https://pi.works/3kTZscp

View source version on businesswire.com: https://www.businesswire.com/news/home/20201123006260/en/

Contacts

Media, P.I. Works, Melih Murat, marketing@piworks.net

Permalink : https://www.aetoswire.com/news/becloud-selects-pi-works-to-drive-automation-of-its-nationwide-multi-operator-and-multi-vendor-lte-network/en

Kymeta™ Announces Commercial Availability of its Next-Generation Antenna, Terminal, and Services Making Mobile Global

The integration of Kymeta’s next-generation solutions, the Antenna, Terminal, and Kymeta Connect Service, support unparalleled global mobile satellite-cellular connectivity 

REDMOND, Wash.-Tuesday 1 December 2020 [ AETOS Wire ]

(BUSINESS WIRE)-- Kymeta (www.kymetacorp.com)—the communications company making mobile global—announced that the Kymeta™ u8 and Kymeta Connect™ are available for government and commercial purchase after November 30, 2020, unlocking the potential of broadband satellite connectivity and cellular networks to satisfy the overwhelming demand for communications on the move.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201130005022/en/

Kymeta’s next-generation solutions are built for mobility and designed to meet the needs of global defense agencies, government, first responders, and commercial customers. Kymeta’s products and services have been field deployed for three years and the demand for the Kymeta u8 presales has already exceeded expectations. With the introduction of the Kymeta u8, the company has meaningfully increased antenna throughput and significantly reduced the total cost of ownership. Kymeta’s new products and services offer a breakthrough in performance, ease of use, and affordability, and it anticipates that these solutions will further enhance its position in both commercial and government markets, further increasing its lead over competitive offerings.

“Government and military need the most reliable and seamless connectivity to safely fulfill their missions,” said Walter Berger, Kymeta President, and COO. “These men and women often go to the most remote or disaster-stricken areas of the world, and they need reliable communications to rescue lives, keep property safe, and complete missions. Our government, military, and commercial customers trust Kymeta solutions. The enhanced performance of the u8 is helping our customers make fast, easy, and reliable mission-critical communications on the move a reality.”

The launch of Kymeta’s next-generation solutions builds on the successful deployment of our beta program earlier this year to facilitate real-world testing. The testing demonstrated throughputs of over 45Mbps in land mobile environment with large scan-off angles of over 50 degrees, which is a remarkable achievement for such a low power (<150W) electronically steered antenna platform. The u8 was tested in regions around the world including North America, APAC, and Europe, in a variety of conditions confirming that the product can be operated with confidence even under the most trying scenarios.

“My team works in some of the most densely populated, rugged, and steep forest terrain in the U.S.,” said Tim Dunfee, Deputy Forest Fire Chief, U.S. Forest Service. “There are places across our varied terrain that have been engulfed by fires and communications cell towers that have been destroyed, causing loss of all communications. When we tested Kymeta’s solutions, we could use FaceTime and make voice calls for the first time. We now have a Kymeta antenna installed on one of our vehicles and deploy it to every forest fire because we know it has reliable communications wherever it goes.”

The Kymeta u8 covers the full Ku-band and is designed to be LEO upgradeable. The u8 is available as an antenna, an ODU (with no modem), and a turnkey terminal with embedded satellite modem, cellular modem, and SD-WAN capabilities. The Kymeta terminals are easy to set up and they acquire service within minutes of being powered. Also coming soon is a transportable configuration called the u8 GO, which is ideal for rapid deployments. The u8 GO will enable safe transport with a hardened case for protection and provides a built-in car mount to support easy operations on the pause and on the move.

Combining the u8 with Kymeta’s hybrid satellite-cellular connectivity services, Kymeta Connect transforms the purchase and consumption of mobile data delivering a complete end-to-end solution with a best-in-industry customer experience. The all-inclusive hybrid satellite-cellular connectivity, global support, and network services package start at $999 per month.

Kymeta Connect is powered by a virtual architecture consisting of an operational stack that connects remote terminals to managed satellite and cellular services, integrates a state-of-the-art digital back office for service and subscription management, and includes an operations and care element to deliver an excellent customer experience. These services are augmented with a unique application called Access which simplifies the control, management, and monitoring of all hardware and connectivity solutions. The newly announced app is available for download through the Apple and Google Play stores. Today, Kymeta Access can be used on a tablet or through a web-based portal to interact with hardware, data, customer care, and subscription services.

Kymeta expects to further accelerate its new product development and commercialization of its next-generation solutions and looks forward to sharing more in 2021.

About Kymeta

Kymeta is unlocking the potential of broadband satellite connectivity, combined with cellular networks, to satisfy the overwhelming demand for comms on the move and making mobile global. Lepton Global Solutions, a Kymeta company, hosts the company’s satellite connectivity solutions and offers unique, complete, and turnkey bundled solutions to the market based on best in class technologies and tailored customer-centric services that meet and exceed customer mission requirements. These solutions in tandem with the company’s flat-panel satellite antenna, the first of its kind, and Kymeta Connect™ services provide revolutionary mobile connectivity on satellite and hybrid satellite-cellular networks to customers around the world. Backed by U.S. and international patents and licenses, the Kymeta terminal addresses the need for lightweight, slim, and high-throughput communication systems that do not require mechanical components to steer toward a satellite. Kymeta makes connecting easy – for any vehicle, vessel, or fixed platform.

Kymeta is a privately held company based in Redmond, Washington.

For more information, visit kymetacorp.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201130005022/en/

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Contacts

Business Inquiries for Kymeta:
Jon Maron
Vice President of Marketing and Communications
Kymeta Corporation
+1 425.658.8827
jmaron@kymetacorp.com

Media Inquiries for Kymeta:
Amanda Barry
Associated Director PR, The Summit Group
abarry@summitslc.com

 

Permalink : https://www.aetoswire.com/news/kymetatrade-announces-commercial-availability-of-its-next-generation-antenna-terminal-and-services-making-mobile-global/en

Rhizen Pharmaceuticals Announces US FDA Acceptance of its IND Application for RP7214 in SARS-CoV-2 Infection; Phase 1 Clinical Trial of RP7214 Set to Begin Early December 2020

 • Rhizen announces the approval of its IND by USFDA for its oral DHODH inhibitor for SARS-CoV-2 infection and plans to initiate a first-in-man single ascending dose study in healthy volunteers in early December.

• Initial study to be potentially followed by a multiple-ascending dose study in Covid-19 patients, in line with pre-IND discussions with the FDA.

• RP7214 is potentially a best-in-class, selective, DHODH inhibitor with potent SARS-CoV-2 inhibition and broad anti-inflammatory activity; may support eventual combinations with other anti-viral agents.

LA CHAUX DU FONDS, Switzerland-Tuesday 1 December 2020 [ AETOS Wire ]

(BUSINESS WIRE)-- Rhizen Pharmaceuticals, a clinical-stage oncology-focussed biopharmaceutical company, today announced the approval of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) to study its oral DHODH inhibitor for SARS-CoV-2 infection. The company announced that initial study shall evaluate single ascending doses of RP7214 in healthy volunteers and that dosing is expected to commence in early December 2020. The company also announces positive feedback from the FDA during its pre-IND discussion on its plans to follow-up this study with a multiple-ascending dose study in Covid-19 patients.

Dihydroorotate dehydrogenase (DHOHD) is a key enzyme involved in pyrimidine biosynthesis in the cell. RP7214 is potentially a best-in-class selective DHODH inhibitor that has shown potent inhibition of Covid-19 viral replication. RP7214 has also been studied extensively across multiple inflammation models where it has demonstrated excellent anti-inflammatory activity. Further, the IND-enabling preclinical studies have shown RP7214 to be orally available, safe and tolerable with predictable dose-linear pharmacokinetics. The host-based mechanism of RP7214 could allow complementary combinations with direct acting anti-viral drugs, while the broad anti-inflammatory action could potentially mitigate the cytokine mediated inflammatory symptoms typically seen in SARS-CoV-2 & other viral infections.

Swaroop Vakkalanka, President & CEO of Rhizen Pharmaceuticals said “There is an exceptional need for oral antiviral drugs that are suitable for Covid-19 treatment across all hospital and out-patient settings. We are pleased to advance RP7214 into a Phase 1 clinical trial for the treatment of Covid-19 under a US FDA IND. RP7214 has a unique preclinical profile, high oral bioavailability, robust anti-viral potency and broad anti-inflammatory role, that we expect will translate in the clinic and support its eventual development as a potential treatment for Covid-19”.

About Rhizen Pharmaceuticals S.A.:

Rhizen Pharmaceuticals is an innovative, clinical-stage biopharmaceutical company focused on the discovery and development of novel onco-therapeutics. Since its establishment in 2008, Rhizen has created a diverse pipeline of proprietary drug candidates targeting several cancers and immune associated cellular pathways. Rhizen is headquartered in La-Chaux-de-Fonds, Switzerland. For additional information, please visit www.rhizen.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20201201005815/en/

Contacts

Samyukta Bhagwati

Manager, Corporate Affairs & Communications

Rhizen Pharmaceuticals S.A.

Telephone: +41 32 580 0113

Email: corpcomm@rhizen.com

Permalink : https://www.aetoswire.com/news/rhizen-pharmaceuticals-announces-us-fda-acceptance-of-its-ind-application-for-rp7214-in-sars-cov-2-infection-phase-1-clinical-trial-of-rp7214-set-to-begin-early-december-2020/en