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.
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
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Website: http://www.rhizen.com
Contact
Rhizen Pharmaceuticals S.A.
Samyukta Bhagwati
Manager, Corporate Affairs & Communications
+41 32 580 0113
corpcomm@rhizen.com
This news is a press release provided by Rhizen Pharmaceuticals S.A..
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2020년 12월 7일 10:56