The Center for Drug Evaluation (CDE) has published a list of Q&As regarding the non-clinical and clinical evaluation criteria for new antiviral drugs against emerging COVID-19 variants. The aim is to guide the scientific research, development, and evaluation of new COVID-19 drugs.
Clinical Study Endpoint
For the primary efficacy endpoint of clinical studies in patients with mild or common COVID-19, the CDE notes that with the emergence of the Omicron variant, the pathogenicity has been weakened, and the proportion of patients progressing to severe or critical disease or dying is low. Therefore, proving a drug’s ability to improve clinical outcomes is challenging. Consequently, improvement in clinical efficacy measures (such as time to sustained clinical recovery within an appropriate timeframe) may be considered as the primary efficacy endpoint, with virological measures serving as key secondary efficacy endpoints.
Non-Clinical Pharmacodynamics Research
Regarding non-clinical pharmacodynamics research, the CDE emphasizes that for COVID-19 treatments and prevention drugs, in vitro antiviral activity tests of the current circulating strain of the live virus should be conducted. Combined with pharmacokinetic (PK) data, a comprehensive assessment of whether the non-clinical data supports the clinical trials should be carried out. Pharmacodynamic studies of the current circulating strains using in vivo infection models may also be conducted if necessary.
Nasal and Pharyngeal Sprays
Regarding the clinical value of nasal and pharyngeal sprays, the CDE cautions that while this route of administration may have certain clinical value for preventive indications, in addition to in vitro pharmacodynamics tests, in vivo pharmacodynamics studies in animals are also required to investigate the effectiveness of this route of administration.
Asymptomatic Infections
The CDE currently believes that drug intervention for asymptomatic infections is of limited significance and does not encourage the development of drugs that are lagging in terms of immunological technology.-Fineline Info & Tech
