Enanta Pharmaceuticals Announces Publication in The New England Journal of Medicine of Data from the Phase 2a Human Challenge Study of EDP-938 for the Treatment of Respiratory Syncytial Virus (RSV)
EDP-938 is Currently Being Evaluated in Phase 2 Studies in Pediatric Patients and Hematopoietic Stem Cell Transplant Recipients With RSV
On Track to Report Topline Data from RSVP, a Phase 2b Study in Adults with Community-Acquired RSV Infection, in the Second Quarter of 2022
Excerpt from the Press Release:
WATERTOWN, Mass.–(BUSINESS WIRE)–Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that data from its Phase 2 human challenge study has been published in The New England Journal of Medicine (NEJM).
“The publication of positive results from our Phase 2a human challenge study of EDP-938 in NEJM demonstrates the significance of our work to develop EDP-938 as a potential treatment option for patients with RSV, a deadly virus affecting children, the elderly and the immune compromised for whom there is no vaccine or therapeutic treatment,” said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. “EDP-938 is currently being evaluated in a broad clinical program across multiple patient populations, and we look forward to continuing the development of this important therapy to bring us closer to a treatment for RSV patients.”
The Phase 2a study was a randomized, double-blind, placebo-controlled, human challenge study in healthy adult subjects inoculated with RSV. Once RSV infection was confirmed, subjects were randomized to receive either a once-daily (QD) 600 mg dose of EDP-938, a single 500 mg loading dose (LD) followed by a 300 mg twice daily (BID) dose of EDP-938, or placebo for five days. The primary endpoint was change in viral load (determined by RT-qPCR), as measured by the area under the curve (AUC) from initial dose through Day 12 in the intent-to-treat infected population. A key secondary endpoint measured AUC reduction in total symptom score.
The NEJM publication highlighted results from the Phase 2 human challenge study in which the primary efficacy endpoint was met with a highly statistically significant reduction (p<0.001) in viral load AUC was observed for each of the EDP-938 dosing groups as compared with placebo. EDP-938 lowered viral load AUC to 203.95 ± 173.50 hours x Log10 copies/mL in the QD arm and 217.71 ± 217.55 hours x Log10 copies/mL in the BID arm, compared to 790.15 ± 408.80 hours x Log10 copies/mL in the placebo arm (p<0.001 for each of the EDP-938 groups compared to placebo). There was no statistically significant difference between the two EDP-938 dosing groups.
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