update on promising new drug ABX464

Hey all,

Abivax recently issued a new press statement on phase 2 clinical trails for UC. It's a small sample, but 69% went into clinical remission and 94% benefitted with moderate to severe UC. That is pretty amazing. Mesalamine and other meds tend to have only a 30% remission rate in clinical trials:

" In September 2020, Abivax reported promising results, showing long-lasting efficacy and continued good safety after the two years open-label oral ABX464 Phase 2a maintenance study in subjects with moderate-to-severe active UC who were all intolerant and/or refractory to at least one existing treatment.
69% (11/16) of patients were in clinical remission and 94% (15/16) benefited from a clinical response. 44% (7/16) had endoscopic remission consisting of complete disappearance of colon/rectum lesions (endoscopic Mayo score=0). Median fecal calprotectin, the key biological marker of UC disease activity, which was normalized during the first year of treatment, remained at 31.6 µg/g (normal levels are below 50 µg/g).
The two-year open-label ABX464 maintenance study was conducted in 19 patients without treatment interruption after completion of the randomized, double-blind, placebo-controlled 8 weeks induction study and the one-year open label maintenance study.
A total of 16 patients completed the two-year ABX464 open label maintenance study and showed long-term safety and tolerability of 50mg given orally."

Phase 2 is currently being conducted in US as of Jan 2020. Does anyone know how long it will take to get to approval approximately?

It looks promising. It is interesting that this drug has demonstrated safety as well as antiviral, anti-inflammatory and tissue repair properties in clinical trials in HIV and ulcerative colitis. New in vitro data shows the inhibition of the replication of SARS-CoV-2 (COVID-19).

https://www.abivax.com/pipeline/abx464-for-covid-19/

sounds great

Let's hope! There are enough UC patients with mild and moderate disease that don't respond to mesalamine or only partially respond. It seems like mesalamine has been the only option for the last 30 years for people that don't want to suppress immune system or risk infections. This is not adequate.

it's not a good business for them to treat uc with simpler methods than humira and remi