Wolwo Bio-Pharmaceutical's Aspergillus fumigatus prick solution completes phase 1 trial

Zhejiang Wolwo Bio-Pharmaceutical announced the successful completion of the Phase 1 clinical trial for its Aspergillus fumigatus prick solution, a novel biological product for diagnosis. The study, conducted at Tongji Hospital, explored the solution's safety and efficacy in Chinese volunteers. Results indicated good safety within the dose range of 55 DU/mL to 495000 DU/mL, with all adverse events reported as Grade 1 or 2, and no serious adverse reactions or study withdrawals.

The solution showed over 95% specificity across all doses and increasing sensitivity with higher doses, reaching 95% at 55000 DU/mL. Researchers recommend doses of 55000 DU/mL and above for subsequent clinical studies. This product is expected to complement Wolwo Bio-Pharmaceutical's existing eight prick solution products.

The company plans to proceed with Phase 2 and 3 clinical trials, followed by a marketing authorization application. However, Wolwo Bio-Pharmaceutical cautioned that the outcome remains uncertain due to the complex nature of drug development and inherent risks.