Replies to post #2238 on Enanta Pharmaceuticals Inc (ENTA)

[JK2016]

Thoughts?

[vinmantoo]

ENTA’s phase-2b trial in RSV misses primary endpoint:

Disappointing news but this doesn't mean the end of the RSV program but it is delayed and in trouble. The fact the challenge trial was successful gives me some hope that the high risk population might fare better than the healthy population in the failed phase 2b. Add in that the L protein inhibitor will soon enter trials a combination trial could be in the future.

On the heels of this disappointing RSV trial, ENTA is riskier now given the HepB program is on hold until ENTA gets their second drug into trials. Unless one is found or ENTA can find another company to provide that second drug, everything in the rest of the year rides on EDP-235.

[DewDiligence]

ENTA starts phase-2b trial_of EDP-938 in high-risk adults:

https://finance.yahoo.com/news/enanta-pharmaceuticals-initiates-phase-2b-110000822.html

The Phase 2b, randomized, double-blind, placebo-controlled, multi-center, global study is designed to evaluate the effect of EDP-938 compared with placebo on the progression of RSV infection by assessment of clinical symptoms. Approximately 180 patients will be treated with 800 mg of EDP-938 or placebo for 5 days and evaluated for 28 days thereafter.

The study will include non-hospitalized adult subjects with up to 72 hours of respiratory tract infection symptoms who test positive for RSV and negative for influenza virus and SARS-CoV-2. Patients will be considered high risk for complications after RSV infection if they have at least one of the following risk factors: age 65 years or older, congestive heart failure, COPD or asthma.

The primary endpoint of the study is time to resolution of RSV lower respiratory tract disease symptoms as assessed by the Respiratory Infection Intensity and Impact Questionnaire (RiiQ) symptom scale through Day 33. Secondary endpoints include additional clinical efficacy measures and antiviral activity compared to placebo, pharmacokinetics, and safety of EDP-938.

The prior phase-2b trial of EDP-938 that missed its primary endpoint was in low-risk adults, who recovered well enough on their own to make EDP-938 non-statsig relative to placebo.