Replies to post #237974 on Biotech Values

[linhdtu]

Dew, i am currently taking Vemlidy and my HBV quant test says "below detectable or not detectable levels" (i can't remember for sure )

so is there another more sentive HBV quant test that biotech like ENTA have that can do what Quest Diagnostic cannot ?

[rwwine]

Very good summary. Thank you Dew for the write up.

[dewophile]

The patients in the EDP-514 trial reported on today were nuke-suppressed, which means they had very low viral loads at baseline. That’s why the mean reduction in HBV RNA from baseline was only 1.0 logs (at 28 days) in the EDP-514 arms.

I am assuming these patients have HBV DNA that is undetectable at baseline, so vial loads per se have no further room to go down. These patients still have circulating RNA, which can then serve (supposedly) as a surrogate for cccDNA. At least that is my understanding - maybe they clarified on the cc but I haven't gotten to it yet

[DewDiligence]

ENTA will unveil preclinical data on its oral HBV RNA destablizer, EDP-721, at EASL:

https://finance.yahoo.com/news/enanta-pharmaceuticals-present-preclinical-data-110000538.html

Please see #msg-163654846 (bottom) for background info.

[DewDiligence]

ENTA reports_positive_phase-1b_data_for EDP-514 in_viremic_HBV patients:

https://www.enanta.com/investors/news-releases/press-release/2021/Enanta-Pharmaceuticals-Reports-Positive-Data-from-Phase-1b-Study-of-EDP-514-a-Hepatitis-B-Virus-HBV-Core-Inhibitor-in-Viremic-Chronic-HBV-Patients/default.aspx

Enanta Pharmaceuticals…today announced positive data from the first two dose cohorts of its Phase 1b study of EDP-514 in viremic chronic HBV patients who were not being treated with a nucleoside reverse transcriptase inhibitor (NUC). The data demonstrated that EDP-514, Enanta’s novel class II oral HBV core inhibitor, was safe and well-tolerated through 28 days of treatment, displayed pharmacokinetics (PK) supportive of once-daily dosing, and resulted in mean HBV DNA reductions of 2.9 and 3.3 logs at 28 days for the 200 mg and 400 mg cohorts, respectively.

“We are extremely pleased with these promising clinical results for EDP-514, which are comparable to the best antiviral effects reported for any core inhibitor to date and also extend the compound’s excellent safety and tolerability profile,” said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. “In particular, we are encouraged by the rapid and robust declines in HBV DNA, which position EDP-514 to be a key component of a combination regimen for HBV. We believe EDP-514, in combination with a NUC and other mechanisms [i.e. EDP-721, ENTA’s small-molecule RNA destabilizer (#msg-164178077)], could provide a foundation for an all-oral treatment approach to achieve functional cures in patients with chronic HBV infection.

The third dosing cohort from this phase-1b EDP-514 trial (800mg; n=6) is still in progress.

Please see the bottom of #msg-163654846 for related info.