Ascletis Pharma : FDA Approves IND Of Oral 3CLpro Inhibitor ASC11 For COVID-19

Ascletis Pharma Inc. said Wednesday that the U.S. Food and Drug Administration has approved the Investigational New Drug (IND) application of ASC11, an oral inhibitor drug candidate targeting 3-chymotrypsin like protease (3CLpro) for COVID-19.

The FDA has approved to study safety, tolerability and pharmacokinetics of ASC11 at various doses in healthy subjects co-dosed with 100 mg ritonavir tablets. Both ASC11 and ritonavir tablets are manufactured by Ascletis.

According to the company, the Phase I clinical trial will consist of 3 cohorts in healthy subjects, including single- and multiple-dose escalation studies and food effect study. The objective of Phase I trial is to find a right dose to move into the pivotal Phase II/III in COVID-19 patients.

In antiviral cellular assays with infectious SARS-CoV-2, ASC11 demonstrated much higher potency against SARS-CoV-2 than other 3-chymotrypsin like protease (3CLpro) inhibitors including Nirmatrelvir, S-217622, PBI-0451 and EDP-235.

Ascletis noted that it has filed global patent applications for ASC11 and related compounds and their use in viral disease.

For More Such Health News, visit rttnews.com

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Google, owned by Alphabet Inc., plans to merge its teams working on Maps products and the mapping service Waze with effect from December 9, reports said. The decision to consolidate processes comes as the search giant is facing pressure to streamline operations and cut costs. The restructuring is expected to reduce overlapping work across the Waze and Maps products. The Pentagon announced that up to $9 billion worth of cloud-computing contracts were awarded to Google, Oracle, Amazon, and Microsoft. In a statement, the U.S. Department of Defense said, "The purpose of this contract is to provide the Department of Defense with enterprise-wide, globally available cloud services across all security domains and classification levels..." Juul Labs, an e-cigarette maker, said it has reached settlements with more than 5,000 vaping lawsuits in the United States. The cases were related to personal injury, consumer class action, government entity, and Native American tribes. In a statement, the company said it cannot disclose the settlement amount at this time as part of the settlement and court process.
Follow RTT