This weekly Immunology update covers late-stage clinical readouts, regulatory clearances, AI-enabled trial operations, financing, and partnerships across inflammatory and skin disease research.
In Today’s Newsletter
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In Today’s Newsletter
🧴 Amlitelimab Phase 3 wins in AD, plus 52-week Phase 2 signals [1] [EU • 23 Jan 2026]
https://www.sanofi.com/en/media-room/press-releases/2026/2026-01-23-06-00-00-3224400
Context: SHORE and COAST 2 Phase 3 in moderate-to-severe AD; ATLANTIS Phase 2 open-label through Week 52.
Key point: SHORE met all primary and key secondary endpoints across US and EU estimands. COAST 2 met the US vIGA-AD 0/1 primary endpoint, missed EU co-primaries. ATLANTIS showed progressive improvement to Week 52.
Implication: May influence prescriber choice and payer reviews pending full data.
💊 Rabeprazole protects gastric mucosa with potent antiplatelets [2] [23 Jan 2026]
https://www.koreabiomed.com/news/articleViewAmp.html?idxno=30401
Context: Prospective 8-week study, 50 ACS patients on ticagrelor-based DAPT; MLS assessed endoscopically.
Key point: Median MLS remained 2.0 at 8 weeks, no worsening of gastric injury, no serious bleeding or major CV events reported.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🧠 FDA clears ATH-063 Phase 2 in ulcerative colitis [3] [US • 22 Jan 2026]
https://www.biospace.com/press-releases/athos-therapeutics-receives-us-fda-authorization-to-begin-multi-center-phase-2-clinical-trial-of-ath-063-in-patients-with-ulcerative-colitis
Context: ATH-063, oral small molecule for IBD; Phase 2 in moderately to severely active, biologic-refractory UC.
Key point: FDA authorized an international Phase 2; Athos will embed multi-omic analyses via AthosOmics.AI (endpoint not specified).
Implication: May influence prescriber choice and payer reviews pending full data.
📊 AI for IBD trial operations shown in Congress poster [4] [US • 22 Jan 2026]
https://www.prnewswire.com/il/news-releases/phasev-demonstrates-how-ai-driven-site-selection-and-real-time-analytics-reduce-recruitment-uncertainty-and-accelerate-ibd-clinical-trials-302667974.html
Context: PhaseV poster at Crohn’s & Colitis Congress; collaboration with Crohn’s & Colitis Foundation using IBD Plexus.
Key point: Causal ML platform modeled patient and site covariates to optimize site selection and real-time performance oversight.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🌙 Real-world belimumab shows cutaneous benefit in SLE/CLE [5] [22 Jan 2026]
https://www.dermatologytimes.com/view/long-term-real-world-data-show-cutaneous-benefits-of-belimumab
Context: German retrospective cohort, 29 adults with SLE and active skin disease; up to 5-year follow-up.
Key point: CLASI scores improved from baseline by 3 months and sustained long term; CLASI-20 common by 6 months, with higher response thresholds over time.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🧪 Delgocitinib cream enters Phase 3 in lichen sclerosus [6] [EU • 21 Jan 2026]
https://www.leo-pharma.com/media-center/news/2026-delgocitinib-ls-trial-initiation
Context: DELTA CARE 1 planning up to 652 adults across 80–90 sites in North America and Europe.
Key point: LEO initiated Phase 3 to assess pan-JAK topical delgocitinib vs vehicle in LS, where no therapies are approved in US or EU.
Implication: May influence prescriber choice and payer reviews pending full data.
🧬 Atopia’s ATP-R13 shows preclinical oral AD efficacy [7] [22 Jan 2026]
https://www.dermatologytimes.com/view/atopia-therapeutics-reports-positive-preclinical-data-for-atp-r13-as-disease-modifying-oral-ad-therapy
Context: Ovalbumin-induced mouse model; ATP-R13 is an optimized recombinant protein modulating tolerogenic pathways.
Key point: Oral ATP-R13 reduced skin thickness and pathology, comparable to dexamethasone; patentability report positive, potential protection to 2043.
Implication: Signals pipeline investment and modality expansion.
🧯 TRexBio raises $50M for tissue-targeted Treg meds [8] [US • 27 Jan 2026]
https://www.businesswire.com/news/home/20260127311389/en/TRexBio-Closes-%2450-Million-Financing-to-Support-a-Growing-Clinical-Stage-Immunology-Pipeline-of-Tissue-Targeted-Treg-Therapeutics
Context: Investors include Janus Henderson, Balyasny, Affinity, and strategics; TRB-061 in Phase 1a/b for AD.
Key point: Funds advance TRB-061, a TNFR2 agonist for skin and barrier tissues, and move TRB-071/-081 toward clinic.
Implication: Signals pipeline investment and modality expansion.
🔗 Boehringer–Simcere €1.05B biobucks IBD bispecific deal [9] [27 Jan 2026]
https://www.fiercebiotech.com/biotech/boehringer-pens-eu105b-deal-simceres-preclinical-ibd-bispecific
Context: Licensing of SIM0709 outside China; preclinical TL1A–IL-23p19 bispecific with synergistic activity in models.
Key point: Aggregate payments up to €1.05B for global rights ex-China; complements Boehringer’s IBD footprint.
Implication: Signals pipeline investment and modality expansion.
Why it matters
- OX40L blockade with amlitelimab advances as a potential Q12W AD option, adding a new MOA alongside IL-4/13 and JAK paths [1].
- AI-enabled trial operations aim to reduce IBD recruitment risk and heterogeneity, a key bottleneck in GI studies [4].
- LS lacks approved therapies, so a topical pan-JAK in Phase 3 could shift standards if positive [6].
- Financing and BD moves indicate sustained investor appetite for Treg modulation and TL1A biology in immune disease [8][9].
- Real-world and preclinical datasets continue to bridge gaps where randomized or indication-specific data are scarce [5][7].
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FAQ
What did Sanofi’s amlitelimab actually meet in Phase 3?
SHORE met all primary and key secondary endpoints across US and EU estimands at Week 24. COAST 2 met the US vIGA-AD 0/1 primary endpoint, but EU co-primaries were not met. ATLANTIS Phase 2 showed progressive improvements to Week 52 [1].
What is ATH-063 and who are the target patients?
ATH-063 is an oral small molecule for IBD. FDA authorized a Phase 2 trial in moderately to severely active, biologic-refractory ulcerative colitis. Endpoints were not specified in the release [3].
How does PhaseV’s platform help IBD trials?
It uses causal ML with IBD Plexus data to predict site recruitment and data quality, align sites to protocol criteria, and provide real-time dashboards for adherence and deviations [4].
Why is delgocitinib in LS notable?
There are no approved LS treatments in the US or EU. LEO’s Phase 3 will test a topical pan-JAK inhibitor in up to 652 adults across multiple countries [6].
What is TRB-061 and how does it work?
TRB-061 is a TNFR2 agonist designed to selectively activate tissue Tregs in skin and other barrier tissues. It is in a Phase 1a/b study for atopic dermatitis [8].
What targets are in Boehringer–Simcere’s bispecific?
SIM0709 targets TL1A and IL-23p19, showing synergistic preclinical efficacy. Boehringer licensed rights ex-China in a deal worth up to €1.05B in biobucks [9].
Entities / Keywords
Amlitelimab (Sanofi; OX40L) • Atopic dermatitis • SHORE • COAST 2 • ATLANTIS • Rabeprazole • Ticagrelor • Modified Lanza Score • ATH-063 (Athos Therapeutics) • Ulcerative colitis • PhaseV • IBD Plexus • Belimumab (BLyS/BAFF) • CLASI • Delgocitinib (LEO Pharma; Anzupgo) • Lichen sclerosus • ATP-R13 (Atopia Therapeutics) • Treg • TRB-061 (TRexBio; TNFR2 agonist) • SIM0709 (Simcere) • TL1A • IL-23p19 • Boehringer Ingelheim.
References
- https://www.sanofi.com/en/media-room/press-releases/2026/2026-01-23-06-00-00-3224400
- https://www.koreabiomed.com/news/articleViewAmp.html?idxno=30401
- https://www.biospace.com/press-releases/athos-therapeutics-receives-us-fda-authorization-to-begin-multi-center-phase-2-clinical-trial-of-ath-063-in-patients-with-ulcerative-colitis
- https://www.prnewswire.com/il/news-releases/phasev-demonstrates-how-ai-driven-site-selection-and-real-time-analytics-reduce-recruitment-uncertainty-and-accelerate-ibd-clinical-trials-302667974.html
- https://www.dermatologytimes.com/view/long-term-real-world-data-show-cutaneous-benefits-of-belimumab
- https://www.leo-pharma.com/media-center/news/2026-delgocitinib-ls-trial-initiation
- https://www.dermatologytimes.com/view/atopia-therapeutics-reports-positive-preclinical-data-for-atp-r13-as-disease-modifying-oral-ad-therapy
- https://www.businesswire.com/news/home/20260127311389/en/TRexBio-Closes-%2450-Million-Financing-to-Support-a-Growing-Clinical-Stage-Immunology-Pipeline-of-Tissue-Targeted-Treg-Therapeutics
- https://www.fiercebiotech.com/biotech/boehringer-pens-eu105b-deal-simceres-preclinical-ibd-bispecific