Biotech Values

[DewDiligence]

AVIR modifies phase-3 protocol for COVID antiviral, bemnifosbuvir—(f/k/a AT-527):

https://ir.ateapharma.com/news-releases/news-release-details/atea-pharmaceuticals-reports-second-quarter-2023-financial

The SUNRISE phase-3 trial has been upsized from 1,300 to 2,200 patients in the monotherapy cohort and the enrollment criteria have been loosened by accepting somewhat younger patients (depending on risk factors) and patients with renal impairment.

There are now two interim analyses after 650 and 1,300 patients have been enrolled for 29 days. The primary endpoint remains the rate of hospitalization or death at day 29 in the monotherapy cohort. AVIR says the final analysis is expected in mid-2024, but that’s optimistic, IMO.

Bemnifosbuvir is a nucleoside polymerase inhibitor that was designed for HCV and has been repurposed for COVID. The drug is not especially potent against SARS-CoV-2, which is why the daily dose being tested in the SUNRISE trial is a whopping 1100mg (550mg BID).

AVIR does have one thing in its favor: a cash balance of $647M at 6/30/23.