Clinical-stage biopharmaceutical company Ansun Biopharma Inc announced on Monday that its independent Data Monitoring Committee (DMC) has issued a positive recommendation following a prespecified interim efficacy and safety review of the company's Phase 3 clinical trial (DAS181-3-01).

DAS181 (Fludase) is being evaluated for the treatment of parainfluenza pneumonia infection in immunocompromised patients requiring oxygen support.

In its second scheduled review, the DMC evaluated interim safety and primary endpoint efficacy data at approximately the prespecified 75% information fraction for the originally planned 72-subject Cohort 1 sample size. The review was conducted pursuant to prespecified procedures in the study protocol and statistical analysis plan. The study remains blinded.

Following its review, the DMC recommended that the study continue and that the sample size be updated based on prespecified recalculation to support adequate statistical power for the final analysis. The Committee noted that the observed interim results indicate the study is in the 'promising zone' as defined in the protocol.