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ENTA > EDP-938 Phase 2A positive topline results for RSV...

Enanta Pharmaceuticals Announces Topline Results Showing EDP-938 Achieved its Primary and Secondary Endpoints in its Phase 2a Human Challenge Study in Healthy Adults Infected with Respiratory Syncytial Virus (RSV)

https://finance.yahoo.com/news/enanta-pharmaceuticals-announces-topline-results-100000233.html

EDP-938 Phase 2a Challenge Study Topline Results
The Phase 2a study was a randomized, double-blind, placebo-controlled, human challenge study in healthy adult subjects inoculated with RSV.

Subjects were randomized into 1 of 2 dosing arms or a placebo arm and received either a once-daily (QD) 600 mg dose, a single 500 mg loading dose (LD) followed by a 300 mg twice daily (BID) dose, or placebo for 5 days.

A total of 115 subjects were enrolled and inoculated with the challenge virus. Once RSV infection was confirmed, participants were then randomized: 38 in the placebo arm, 39 in the 600 mg QD arm (one subject was randomized, but never dosed), and 38 in the 500mg LD plus 300mg BID arm.

A highly statistically significant reduction was observed for the primary efficacy endpoint, the area under the curve (AUC) for viral load in the intent-to-treat-infected population (ITT-I: all randomized subjects receiving challenge virus and at least one dose of study drug with confirmed RSV infection) for each of the EDP-938 dosing groups as compared with placebo. Specifically, 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.

For the key secondary efficacy endpoint, the AUC for total symptom score (TSS), a highly statistically significant reduction was observed in the ITT-I population for each of the EDP-938 dosing groups (124.47 hours x score ± 115.60 for the QD arm and 181.75 ± 248.42 hours x score for the BID arm, compared to 478.75 ± 422.29 hours x score 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.

EDP-938 demonstrated good pharmacokinetics, and mean trough levels of drug were maintained at approximately 20-40x above the in vitro EC90 for RSV-infected human cells.

Overall, EDP-938 was generally safe and well tolerated. EDP-938 demonstrated a favorable safety profile over 5 days of dosing through Day 28 of follow-up, comparable to placebo for both dosing groups. There were no serious adverse events and no discontinuation of study drug.

The study will be presented at a future medical conference.

Conference Call and Webcast Information
Enanta will host a conference call and webcast today at 8:30 a.m. ET. To participate in the live conference call, please dial [phone] in the U.S. or [phone] for international callers. A replay of the conference call will be available starting at approximately 11:30 a.m. ET on June 14, 2019, through 11:59 p.m. ET on June 16, 2019 by dialing [phone] from the U.S. or [phone] for international callers. The passcode for both the live call and the replay is 1274559. A live audio webcast of the call and replay can be accessed by visiting the “Events and Presentation” section on the “Investors” page of Enanta’s website at www.enanta.com.