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update on promising new drug ABX464

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Ulcerative Colitis
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Jane974
Regular Member
Joined : Feb 2017
Posts : 375
Posted 12/3/2020 9:49 PM (GMT -7)
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?
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ambling
Veteran Member
Joined : Feb 2011
Posts : 1025
Posted 12/4/2020 1:32 AM (GMT -7)
Another very interesting, clever, small molecule that reduces the inflammatory response.
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Oligodar
Regular Member
Joined : Jul 2017
Posts : 235
Posted 12/4/2020 1:48 PM (GMT -7)
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/
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Old Hat
Veteran Member
Joined : Feb 2007
Posts : 5429
Posted 12/4/2020 2:47 PM (GMT -7)
Very interesting info-- thanks for updating us! Fingers crossed! (Sounds almost too helpful to be true.) / Old Hat (40 yrs with left-sided UC)
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ewafromwarsaw
Veteran Member
Joined : Jun 2013
Posts : 1407
Posted 12/7/2020 5:13 PM (GMT -7)
sounds great smile
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enjoygolf
Regular Member
Joined : Jan 2012
Posts : 139
Posted 12/8/2020 6:35 AM (GMT -7)
Looks like this could be another option. They are conducting trials in a lot of countries. Maybe they will open up more in the USA. Thanks for the update.
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Jane974
Regular Member
Joined : Feb 2017
Posts : 375
Posted 12/11/2020 11:08 AM (GMT -7)
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.
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geezernow
Regular Member
Joined : Nov 2017
Posts : 211
Posted 12/18/2020 1:59 AM (GMT -7)
probably another 5 years! Funny how the big drug companies can pop out a covid vaccine in a year but it takes YEARS to get a UC drug approved in this country. Oh well....I suppose better safe than sorry. Best of luck to all and happy holidays.
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ewafromwarsaw
Veteran Member
Joined : Jun 2013
Posts : 1407
Posted 12/19/2020 4:36 PM (GMT -7)
it's not a good business for them to treat uc with simpler methods than humira and remi
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NiceCupOfTea
Elite Member
Joined : Jan 2010
Posts : 11009
Posted 12/19/2020 9:03 PM (GMT -7)

geezernow said...
probably another 5 years! Funny how the big drug companies can pop out a covid vaccine in a year but it takes YEARS to get a UC drug approved in this country. Oh well....I suppose better safe than sorry. Best of luck to all and happy holidays.

If UC was as contagious as Covid, you'd be seeing a new UC drug in a year as well. Drug/vaccine trials are usually caught up in years of red tape and applications for funding. That didn't happen with the Covid vaccine, as it got fast-tracked through everything.

Edit: Just saw that this was my 11,000th post :D
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