Navigating life with terminal disabled son. FDA/World Regulatory Affairs. Stock posts ≠ financial advice. Regulatory posts ≠ endorsement of FDA’s actions.
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Came across this full Obe Phase 2 maintenance study data that I had missed earlier until hound shared with me few days ago. Couldn’t find Abivax publishing this level of details in any previous PRs.
- Endoscopic remission (ER) of 37.9 % in responders gives me assurance that bias in clinical remission (CR) 66.1% might be minimal. That is because patient bias is not possible in endoscopic healing and symptoms improve faster than complete bowel healing. It is established standard that CR trends ~ double of ER in UC maintenance trials. I would be worried if ER was worse like around 15%. Also, one component of CR is endoscopic subscore assessment which helps with accuracy of overall CR reporting and reduce symptom bias.
- ER can be influenced by Corticosteroids (CS) but Abivax did voluntary CS-free assessment and CR and ER in those patients were 37.4% and 23.5% respectively. Importantly this was done per FDA standard of min 12-week steroid free before assessment. 21 patients achieved CR from those who didn’t voluntarily taper CS. Results in CS patients were of the same proportion as overall study population. CS-free efficacy would have been even higher if there was forced tapering like required in phase 3 maintenance.
- Durability might help placebo a little so it will help the drug arm. Induction results in phase 3 are better than phase 2.
Overall, if pattern and math from phase 2 OLM holds in phase 3, high probability we see ~ 55% CR in 50mg arm with Placebo around 17-20% and delta ~ 35-38%. IMO.
pmc.ncbi.nlm.nih.gov/article…
Bio investment alone is a full-time job. 8-10 hr of work + 6-8 hrs of caretaker for fully disabled trach kid and with barely getting any decent sleep and then to add BioX interactions and investment etc on that. So far I have been keeping only to the area I know about the most. Something I can research in under 30 min and make it work. That’s all I got. Good luck to Adam and also many other good accounts left or went quiet this year to pursue other opportunities.
As I've shared with several people privately over the last several weeks, I'll be taking a break from engaging on X shortly after the $ZURA readout comes in. I decided this quite a while ago, but also decided I wanted to see this pitch through before peacing out.
I also want to make the expectation of a break completely clear ahead of time: The break is happening whether Zura hits or misses...Just pre-empting the trolls who will gleefully claim that "Adumb quit X because he got a pitch wrong" in the event that ZURA doesn't work out. Simply not the case (not that this will actually stop their jabs). Even if ZURA hits and rockets, the break is happening independent of that.
Permanent? You never know, but I do doubt that it will be.
Nothing "wrong" on my end - just a life that is increasingly busy to the point of being unsustainable, and this is an easy variable to modulate. I've got a lot that I want to catch up on, and I won't be back until I feel comfortable that has happened.
Will likely still check my DMs occasionally, but no promises there - I've got *hundreds* of unread DMs as it is BEFORE stepping away (sorry to everyone in that ghosted boat - nothing personal).
Now, hopefully we can get some nice biotech tailwinds to celebrate over the next few weeks until its "goodbye for now"!
****Some Basics for you when you read AEs in future****
Disease of long latency ————-Cancers, TB, some infections ————-low regulatory scrutiny————-higher chances of clean label & a standard 10-15 year post market monitoring study commitment
Acute or immediate onset diseases ——— Cardiac arrest, sudden death, anaphylaxis, stroke, some infections etc. ——Higher regulatory scrutiny———higher chances of blackbox/warning precautions labels with 3-5 year post market observational study commitment
$GILD Entire 75mg arm is questionable but to me most interesting numbers are the huge differences in %response and %remission in 75mg and placebo arm. It is statistically impossible. Such wide gap doesn’t happen even in severe high refractory patients and Emvi trial has mostly naive patients. May be mathematical error? Or some sites didn’t calculate endoscopic subscore accurately and therefore some remission patients were counted as responders?Anyways, I think IL-23 oral acquisition is done to calm investors. I don’t think gilead will do phase 3 with Emvi combo. At some point Emvi will be dropped quietly.
$GILD
So if I assume the trial was honest and adjust these numbers with how response & remission relate historically in UC trials, 75 mg and placebo CR should have been ~25% and ~15% respectively. As such, 200mg CR delta would have been in line with management guidance of ~15% and not ~22%. I would just call this drug 15% induction delta moving forward. All other P2 drugs have hit >19% in last 2-3 years. Even apremilast timepass study was ~20%.
Real test of hypocrisy of media and investors. Let’s see!
Where are my background rate calculators?
#ESMO26 INTerpath-001
8 Grade 5 AEs in the experimental arm, 0 in the control arm.
Of course, it could all be pure coincidence! After all, 6 of the 8 events were not considered TRAE
Perhaps it was just the excitement of being randomized to the experimental arm?
I'm genuinely curious about the independent causality assessment.
This meme got real. You know who!
With these new results this week (treating to endoscopic remission - not symptomatic remission - reduces complications in ulcerative colitis) I did the network meta-analysis to see how the current drugs stack up.
This is every advanced therapy that reported endoscopic remission (Mayo endoscopic subscore=0) in a phase 3 maintenance trial. Drugs that did not report this, that failed, or that were subsequently discontinued are not included.
There is a clear winner:
Unlike IBD endoscopy, you don’t need an airway scope to know if an anti inflammatory or anti fibrotic drug has worked or not in tracheotomy patients most of who have stenosis.
If drug works, air starts flowing through trachea and vocal cords. You feel warm air coming out of nose, start hearing sound and if there is ventilator there will be nonstop air leak alarm. And if these effect gone after dosage stop, maintenance failed. ENT would know what I’m talking about!
The only right way for Merck to announce Tuli data is this.
PR 1 - here is our trash Tuli 15% CR and 5% ER delta (maintenance)
PR 2: Merck has entered in an agreement to acquire ABVX for X$/share
There is no better way.
This has become too obvious at this point. News comes during the perfect week when treasury discussion on going.
Anyways, this is bullish news for ABVX cause it validates its MoA.
#ACG2026: 🇨🇳Hengrui’s Oral miR-124 Modulator HRS-7085 Shows Promising Phase 2 Interim Results in Ulcerative Colitis
HRS-7085 is an oral small-molecule miR-124 modulator.
HRS-7085-201 trial (NCT07229950)
comprises a randomized, double-blind Part 1 and an open-label Part 2.
Part 1 randomized patients 2:2:1 to:
- HRS-7085 10 mg BID, titrated from 5 mg BID for 7 days;
- HRS-7085 20 mg BID, titrated from 5 mg BID to 10 mg BID and then 20 mg BID;
- Placebo.
Interim analysis:
At Week 8, complete efficacy assessments were available for 6 placebo-treated patients, 11 patients receiving 10 mg BID and 9 receiving 20 mg BID.
The HRS-7085 groups had a higher proportion of patients with a baseline endoscopic subscore of 3—72.7% in the 10 mg BID group and 75.0% in the 20 mg BID group, versus 42.9% with placebo
At Week 8, mean changes in fecal calprotectin from baseline were:
- HRS-7085 10 mg BID: −302.0 mg/kg
- HRS-7085 20 mg BID: −143.0 mg/kg
- Placebo: +227.8 mg/kg
TEAEs were predominantly mild to moderate across the three groups.
ABVX is not a cult stock. No any stock has extremely talented folks from every department as this one. A system disruptor. If you see what IBD specialists found out in studies this week, BioX has already studied and concluded those findings a year ago. Again and again. Truly 10 steps ahead of everyone. Yes, there are some humorous folks but it’s fun this site is not LinkedIn as long as they don’t cross boundary.
This is according to me the most important study of UEG that will transform future of IBD treatments, trial designs and also will lead to new guidelines and new ways of labeling!
Prof Vip Jairath VERDICT—basically treating to endoscopic remission in UC was significantly better than treating to symptomatic remission, but treating to histo remission didn’t add anything significant @vipuljairath @UegWeek #uegweek2026
One thing I want to point out for Combo therapy is that FDA has never reviewed IBD combo therapy before. There is no enough data on drug-drug interactions, pharm tox, cmc impurities, genotoxicity etc. So until fda has enough experience, expect higher scrutiny. Phase 3 should give clear picture!
If much lesser bias than below is what you apply to $ABVX, Abtect 1 had ~22% CR and ~28% EI in 8 weeks in much severe refractory population than below in ~650 patients!
And, without bias in ~1300 $ABVX patients 8 week HEMI and Clinical response delta are ~18% and ~31%. So my point is even 10 year olds can design IBD trial that will hit >20% delta but are you developing something that is commercially viable or useful for patients?
Mickeychiku retweeted
What if clinical remission is masking ongoing inflammation in IBD? Symptom-based assessment alone may overlook active disease. Integrating biomarkers, endoscopy, and imaging enables more accurate monitoring and long-term disease control.¹,² Follow us for more!
Everyone: Mufemilast China trial had 44% clinical remission delta. How can someone design such biased trial?
GILD:
DOCTORS in Conferences:
Presents data comparison between two maintenance time points as induction vs maintenance time point. Call open label small N questionnaire based data inferior to 1000 patient placebo controlled data as excellent.
Also DOCTORS to FDA reviewers during Adcom:
In IBD Phase 2 or 3, All functionally immunosuppressant drugs will always achieve decent clinical response and remission induction. Steroid and concomitant use does not give clear picture of drug quality in induction. You will notice that these drugs with decent Clinical remission or response in induction will rarely have endoscopic improvement with the same proportion. I mean other mechanisms will have better endoscopic response than immunosuppressants in induction. Maintenance is the real test of quality of drug cause that’s when most parameters that introduce bias have been removed, the drug effect has stabilized to most extent and it’s mainly the main drug running the show at that point.
Eczema is one disease where everything will work. Detergent, clothing, moisturizers, herbal, ointments, otc, oral drugs, biologics everything. You can handle every disease of the world but you don’t want to deal with this monster. Won’t let you sleep for a minute all night. This is the one brings most people to breaking point.