Wolwo Pharma obtained the summary report of Phase I clinical trial for Aspergillus flavus puncture solution
Wolwo Pharma has completed the Phase I clinical trial of the Aspergillus flavus puncture solution and obtained the summary report. The study shows that the drug has good safety within the set dosage range, with no serious adverse reactions occurring. Some subjects experienced delayed reactions, which may be related to the characteristics of the fungus. The specificity for each dosage exceeded 95%, and the sensitivity reached 95% at 55000 DU/mL. The researchers recommend conducting subsequent clinical studies at doses of 55000 DU/mL and above, and exploring strategies to reduce delayed reactions
According to the Zhitong Finance APP, Wolwo Pharma (300357.SZ) has completed a clinical study titled "A Clinical Study Exploring the Safety and Efficacy of Aspergillus Fumigatus Injection in Chinese Volunteers - A Single-Center, Open-Label Phase I Clinical Study," and has obtained the Phase I clinical trial summary report.
The Aspergillus Fumigatus Injection has shown good safety within the set dosage range (55DU/mL-495000DU/mL), with all adverse events being classified as Grade 1 or 2, and no serious adverse reactions or adverse events leading to withdrawal. A certain proportion of delayed reactions were observed among the subjects, suggesting a possible correlation with the fungal characteristics of Aspergillus. The specificity of the product at all doses was above 95%, with no dose-related effects observed; sensitivity showed an increasing trend with higher doses, reaching 95% at a dose of 55000DU/mL. The researchers believe that based on the review requirements for other allergen injections already on the market, it is recommended that this product use a dose of 55000DU/mL or higher for subsequent clinical studies, and they also suggest exploring better solutions to reduce delayed reactions from a pharmaceutical perspective before conducting further preclinical studies
