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
1.12.2020 18:01:00 EET | Business Wire | Press release
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
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201201005815/en/
Contact information
Samyukta Bhagwati
Manager, Corporate Affairs & Communications
Rhizen Pharmaceuticals S.A.
Telephone: +41 32 580 0113
Email: corpcomm@rhizen.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Ciauru Wins the Second Edition of the Reply AI Music Contest, the International Competition Dedicated to Experimentation Across AI, Music and Live Performance6.7.2026 21:30:00 EEST | Press release
The second edition of the Reply AI Music Contest, the international competition created by Reply to explore new forms of expression combining artificial intelligence, music and live performance, concluded with the announcement of the winner on the Nova Stage powered by Reply during Kappa FuturFestival. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260706007611/en/ The second edition of the Reply AI Music Contest, the international competition created by Reply to explore new forms of expression combining artificial intelligence, music and live performance, concluded with the announcement of the winner on the Nova Stage powered by Reply during Kappa FuturFestival First place went to Ciauru, the stage name of Simone Privitera, an Italian multi-platinum DJ and producer who integrates artificial intelligence tools into a musical practice rooted in the contemporary electronic scene. With a career that has seen him collaborate wit
Rimini Street to Report Second Quarter 2026 Financial Results on July 30, 20266.7.2026 16:00:00 EEST | Press release
Rimini Street, Inc. (Nasdaq: RMNI), the Software Support and Agentic AI ERP Company™ and the leading third-party support provider for Oracle, SAP and VMware software, today announced it will report earnings after market close on July 30, 2026. The company will host a conference call and webcast on that date to discuss the second quarter 2026 results and the second half 2026 outlook at 5:00 p.m. Eastern / 2:00 p.m. Pacific time. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260706560476/en/ Rimini Street to Report Second Quarter 2026 Financial Results on July 30, 2026 A live webcast of the event will be available on Rimini Street’s Investor Relations site via the Rimini Street IR events link and directly via the webcast link. Dial-in participants can access the conference by dialing 1-800-836-8184. A replay of the webcast will be available for one year following the event. About Rimini Street, Inc. Rimini Street, Inc. (Nasda
Orion and Shilpa Medicare Expand Partnership to Develop and Supply Nivolumab Biosimilar for Europe6.7.2026 16:00:00 EEST | Press release
Shilpa Medicare Limited announced that its wholly owned subsidiary, Shilpa Biologicals Private Limited, has entered into a co-development and supply agreement with Orion Corporation for intravenous (IV) nivolumab biosimilar referencing one of the world’s most widely used cancer immunotherapies to widen patient access across Europe. Nivolumab helped usher in the era of immuno-oncology, transforming the outlook for patients with cancers such as melanoma and lung cancer. As the originator approaches loss of exclusivity in Europe, this partnership aims to put a high-quality, EU-GMP-manufactured nivolumab biosimilar within reach of more patients, reducing healthcare burden. In 2025, Nivolumab recorded sales of approximately USD4.1 billion (Source: IQVIA/IMS) Europe — underscoring the scale of the opportunity. Under the agreement, Orion will hold the exclusive rights to register, market, distribute and sell the nivolumab biosimilar across Europe. Shilpa Biologicals will lead product developm
No-Loss Trading Platform UpsideOnly Surpasses 100,000 Users Within Weeks of Launch6.7.2026 15:48:00 EEST | Press release
Perpetuals.com Ltd (Nasdaq: PDC), today announced that UpsideOnly, its risk-free trading and market prediction platform, has seen a surge in new user sign-ups, surpassing the important milestone of 100,000 traders within weeks of its launch on May 19. UpsideOnly lets users make predictions about where global equity, commodity, forex, and crypto markets are heading without ever placing a real trade themselves. Perpetuals uses its own capital to trade on the strongest signals identified by its proprietary AI. If those trades win, Perpetuals shares the profits with the users who helped generate the signal. If the trade doesn’t make money, users lose nothing. Reaching 100,000 users so quickly after launching is a reflection of the enormous demand for a platform that flips the traditional retail trading model on its head, with early platform data showing strong engagement across asset classes, geographies and user activity: Users from more than 180 different countries $38.4 billion in cumul
Klarna Submits Application for U.S. Banking License6.7.2026 15:30:00 EEST | Press release
Klarna (NYSE: KLAR), the global digital bank and flexible payments provider, today announced it has submitted applications to the Utah Department of Financial Institutions and the Federal Deposit Insurance Corporation (FDIC) to establish Klarna Bank USA, a proposed Utah-chartered industrial bank. Klarna has operated as a licensed bank in Europe since 2017 and serves U.S. customers through valued partner banks. Since 2019, Klarna has provided Americans with access to over $91.3 billion in responsible credit, saving them more than $5.1 billion in interest compared to revolving credit card debt. Today, 30 million Americans use Klarna each year, and hundreds of thousands of merchants rely on Klarna to grow their businesses. "Banking is built on trust," said Sebastian Siemiatkowski, co-founder and CEO of Klarna. "We've seen firsthand the appetite for a fairer, more transparent approach in the U.S., and our own banking license is the natural next step, giving customers tools to borrow respon
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom