First Step to Combatting COVID-19: 4 Healthy Subjects Begin Multiple-Dose Clinical Trial of Oral 3CLpro Inhibitor ASC11

Enrolling 72 healthy volunteers, we are excited to launch a multiple-dose escalation Phase I clinical trial in the first quarter of 2023. Be a part of history and join us in this groundbreaking journey!

Ascletis has taken a bold step forward in the fight against viral diseases by filing global patent applications for ASC11 and related compounds. This revolutionary approach unlocks the potential of these compounds to be used in treating a variety of viral diseases.

Ascletis Pharma Inc. (HKEX: 1672) today announced a momentous milestone with the dosing of the first cohort of 4 healthy subjects in a Phase I clinical trial of its 3-chymotrypsin like protease (3CLpro) inhibitor, ASC11, in combination with 100 mg ritonavir tablets to treat COVID-19. This innovative therapy is the first of its kind to be tested in clinical trials and could be a major breakthrough in the fight against this pandemic.

The Phase I clinical trial will enroll 72 healthy subjects in the first quarter of 2023 to assess the safety, tolerability, and pharmacokinetics of ASC11 in combination with 100 mg ritonavir tablets. 60 subjects will receive either single or multiple doses of ASC11 (with or without ritonavir tablets) in a randomized, double-blind and placebo-controlled study. The remaining 12 subjects will be randomized to receive ASC11 in combination with ritonavir tablets with or without food, to evaluate the effect of food on the PK of ASC11.

ASC11 proved to be a powerful antiviral agent against SARS-CoV-2 in cellular assays, outperforming other 3CLpro inhibitors including Nirmatrelvir, S-217622, PBI-0451, and EDP-235. Furthermore, ASC11 was effective against the various Omicron variants such as BA.1 and BA.5. In animal models, ASC11 continued to demonstrate its remarkable antiviral potency against SARS-CoV-2.

ASC11 is an exciting new oral small molecule drug candidate discovered by Ascletis, using proprietary technologies such as molecular docking. This revolutionary discovery has been protected with the filing of global patent applications, with the potential to revolutionize the treatment of viral diseases.

At Ascletis, we are proud to announce that our in-house developed COVID-19 drug candidates, ASC10 (RdRp inhibitor) and ASC11 (3CLpro inhibitor), have both entered clinical development, demonstrating a strong recognition of our R&D capabilities in viral diseases. With the ongoing global pandemic continuing to cause immense social and economic implications, we are committed to accelerating clinical development to combat the crisis in China and abroad. Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis, expressed his enthusiasm for this achievement, saying, “We are excited that our drug candidates have entered clinical development and are ready to fight against the pandemic.”

About Ascletis

Ascletis is a groundbreaking biotech company listed on the Hong Kong Stock Exchange (1672.HK). Its management team is a powerhouse of deep experience and remarkable success. The company focuses on three major therapeutic areas to meet global medical needs: viral diseases, non-alcoholic steatohepatitis (NASH) and oncology. Its impressive portfolio includes three marketed products – ritonavir tablets, GANOVO┬« and ASCLEVIR┬« – and 22 drug candidates in its R&D pipeline, with some of the most advanced ones being ASC22 for CHB, ASC10 and ASC11 for COVID-19, ASC40 for recurrent glioblastoma, ASC42 for PBC, and ASC40 for acne. Through its cutting-edge strategies, Ascletis is determined to become a leader in the global market.

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