Arsanis said that it will discontinue its phase 2 clinical trial of ASN100 for the prevention of S. aureus pneumonia in high-risk, mechanically ventilated patients following the completion of a planned interim analysis of unblinded trial data by an independent data review committee (DRC).
Based on the results of this analysis, the DRC determined that the trial was futile, meaning that it was not likely to meet its primary end-point upon completion and recommended that trial enrollment be discontinued.
Arsanis intends to conduct follow-up visits on all patients dosed with ASN100 per the study protocol.
Arsanis president and CEO René Russo said: “We are disappointed that this clinical study was futile despite the survival benefit of ASN100 as compared to placebo observed in preclinical models of pneumonia, however Arsanis remains confident in the potential of monoclonal antibodies to prevent and treat serious infections, while also reducing the threat of antibiotic resistance.
“We intend to evaluate the complete dataset from the patients that were enrolled in the ASN100 study to better understand the basis for this result and expect to provide an update on the program following this review. We thank the patients and their caregivers who participated in the ASN100 Phase 2 study.”
Russo added: “We will continue to focus our efforts and resources on our other programs, including the development of ASN500 for the prevention of respiratory syncytial virus (RSV) infection, which contributes to 240,000 hospitalizations per year in the U.S.
“Pre-clinical data for ASN500 has demonstrated high potency with potential to offer benefits over existing preventive therapies in terms of dosing strategy, manufacturing and route of administration, to better serve both new and existing target patient populations. We expect to advance ASN500 into Phase 1 clinical trials in 2019.”
Source: Company Press Release