Immunology Weekly News – September 10th 2025

LucidQuest

2 months ago

🔬 This week in Immunology Updates: Gout Treatment, Crohn’s Disease Mapping and More!

From Phase 2 trial results to microbiome-based therapy innovations, these stories are shaping the future of immunology and patient care. Let’s dive into this week’s top updates:

In Today’s Newsletter

🧪 Innovent Biologics Announces Phase 2 Results of Tigulixostat (IBI128) in Gout Patients [1] [07 Sep 2025]

Context: Innovent Biologics presented Phase 2 data of tigulixostat (IBI128) at the 2025 Asia-Pacific League of Associations for Rheumatology (APLAR) Congress. The study showed tigulixostat demonstrated superior urate-lowering efficacy compared to febuxostat across all dose groups, with a favorable safety profile.

Key Point: Tigulixostat achieved significant improvements in serum uric acid (sUA) levels, with a dose-dependent effect, showing 85.7% of participants at 200mg achieving sUA levels <360 μmol/L.

Implication: These results indicate potential for tigulixostat as a new treatment option for gout with enhanced efficacy and a safer profile. Phase 3 trials are expected to begin soon in China.

📱 Yonsei University Develops Technique for Mapping Gut Bacteria and Human Genes in Crohn’s Disease [2] [08 Sep 2025]

Context: Researchers from Yonsei University have developed a new technique to map bacterial infiltration in gut tissue and track gene expression in pediatric Crohn’s disease (CD) patients. This technology offers high-resolution insights into the interactions between the microbiome and human immune cells.

Key Point: The study found that greater bacterial infiltration in the intestines was associated with more severe CD symptoms and poorer prognosis, highlighting the importance of microbiome-based therapies in treatment.

Implication: This approach could lead to more personalized treatments for Crohn’s disease, allowing clinicians to predict disease recurrence and tailor interventions based on microbiome profiles.

💸 MRM Health Raises €55 Million Series B to Advance Microbiome-Based Therapies [3] [08 Sep 2025]

Context: MRM Health closed a €55 million Series B financing to expand its CORAL® platform, which focuses on designing microbiome-based therapeutics for inflammatory diseases and immune-oncology.

Key Point: The funding will support the Phase 2b trial of MH002 for ulcerative colitis and advance two other microbial consortia programs to IND approval.

Implication: The investment boosts MRM Health’s position in the emerging microbiome therapeutics field, offering innovative solutions for chronic inflammatory diseases.

🇺🇸 Boomerang Medical Raises $20 Million to Advance Neuromodulation in Inflammatory Bowel Disease [4] [05 Sep 2025]

Context: Boomerang Medical secured $20 million in Series B funding to advance its pivotal trial, BOOM-IBD2, of neuromodulation for ulcerative colitis (UC).

Key Point: The trial will investigate the efficacy of sacral neuromodulation, a non-pharmacological treatment delivered via a small implanted device, in reducing UC symptom burden.

Implication: If successful, this approach could offer a non-invasive alternative to current UC treatments, providing long-term symptom relief and improving patients’ quality of life.

💊 Palisade Bio Receives Health Canada Clearance for Phase 1b Trial of PALI-2108 in Fibrostenotic Crohn’s Disease [5] [05 Sep 2025]

Context: Palisade Bio received a No Objection Letter (NOL) from Health Canada for the Phase 1b trial of PALI-2108, a dual anti-inflammatory and anti-fibrotic therapy aimed at treating Fibrostenotic Crohn’s Disease (FSCD).

Key Point: PALI-2108 has demonstrated anti-fibrotic and anti-inflammatory effects in preclinical studies, positioning it as a potential treatment for FSCD, a Crohn’s disease complication with no approved therapies.
Implication: PALI-2108 may offer a new treatment option for FSCD, addressing a critical unmet need in Crohn’s disease management.

🌍 Incyte Launches ‘HS Truths’ Campaign to Raise Awareness of Hidradenitis Suppurativa [6] [03 Sep 2025]

Context: Incyte launched a campaign to raise awareness about hidradenitis suppurativa (HS), a chronic inflammatory skin condition. The campaign highlights the emotional and physical toll of HS on patients’ daily lives.

Key Point: The campaign features real stories from patients who describe the debilitating impact of HS on their daily activities, such as sitting for long periods, dressing, and even picking up children.

Implication: The campaign encourages healthcare providers to engage more deeply with HS patients, improving care and helping to reduce the stigma surrounding the disease.

🤝 Arcutis Biotherapeutics Submits sNDA for Zoryve Cream in Pediatric Plaque Psoriasis [7] [04 Sep 2025]

Context: Arcutis Biotherapeutics submitted a supplemental New Drug Application (sNDA) to the FDA for the expansion of Zoryve cream for the treatment of plaque psoriasis in children as young as 2 years old.

Key Point: The cream is a non-steroidal, steroid-free treatment designed for sensitive skin areas, including the face and intertriginous areas, which are commonly affected by plaque psoriasis in children.

Implication: If approved, Zoryve could become the first topical PDE4 inhibitor for pediatric patients under 6, filling a significant treatment gap in pediatric psoriasis management.

💸 Onco3R Therapeutics Announces Clinical Trial Approval for SIK3 Inhibitor O3R-5671 in Autoimmune Diseases [8] [04 Sep 2025]

Context: Onco3R Therapeutics announced the approval of its first-in-human clinical trial for O3R-5671, a SIK3 inhibitor designed to treat a range of autoimmune diseases such as ulcerative colitis and psoriasis.

Key Point: The trial will assess the safety and pharmacokinetics of O3R-5671, with subsequent patient trials planned for later in 2026.

Implication: This new oral therapy offers the potential to overcome the limitations of first-generation SIK inhibitors, positioning it as a promising treatment for autoimmune diseases with better efficacy and fewer side effects.

🏅 Inmedix Raises $44,689 to Support Kids with Autoimmune Diseases at Seattle Children’s [9] [04 Sep 2025]

Context: Inmedix raised $44,689 at its 9th Annual Charity Golf Tournament to support research and programs for children with arthritis and autoimmune diseases at Seattle Children’s Hospital.

Key Point: The event contributed to a total of $210,000 raised over the years, funding critical research and supporting pediatric rheumatology programs.

Implication: Inmedix’s ongoing support underscores the growing need for research and funding to improve the care and treatment of children suffering from chronic autoimmune conditions.

🧪 Real-World Evidence Supports Effectiveness of Neffy® in Treating Anaphylaxis [10] [08 Sep 2025]

Context: ARS Pharmaceuticals released real-world evidence showing that neffy® (epinephrine nasal spray) is highly effective in treating anaphylaxis symptoms in patients undergoing oral food challenges and allergen immunotherapy.

Key Point: Data from the neffy experience program showed that 89.2% of patients were successfully treated with a single dose, reinforcing neffy’s interchangeability with epinephrine injections for anaphylaxis.

Implication: This evidence supports neffy’s potential as a more accessible, effective treatment for anaphylaxis, with a comparable success rate to traditional epinephrine auto-injectors.

Why It Matters

Tigulixostat’s superior urate-lowering efficacy makes it a promising new treatment for gout, offering a safer alternative to current therapies.

The microbiome-gut interaction technique developed by Yonsei University could help predict disease progression in Crohn’s disease, paving the way for more personalized treatments.

The €55 million raised by MRM Health is a major step in advancing microbiome-based therapies, which could provide new solutions for ulcerative colitis and other inflammatory diseases.

Boomerang Medical’s pivotal trial in ulcerative colitis offers hope for a non-pharmacological treatment option through sacral neuromodulation.

Palisade Bio’s innovative approach to treating Fibrostenotic Crohn’s Disease could fill a major gap in Crohn’s disease therapies.

Incyte’s HS Truths campaign highlights the often-overlooked emotional and physical burden of hidradenitis suppurativa, aiming to improve patient-provider communication.

Arcutis Biotherapeutics is on track to provide the first steroid-free treatment option for pediatric plaque psoriasis, addressing a significant treatment gap.

Onco3R’s approval to begin clinical trials for its SIK3 inhibitor represents a breakthrough in autoimmune disease treatments with better efficacy and fewer side effects.

Inmedix’s charitable contributions support ongoing research and treatment advancements for children with autoimmune diseases.
Neffy®’s real-world effectiveness in treating anaphylaxis reinforces its potential as a more accessible and equally effective alternative to epinephrine injections.

📢 Stay Ahead in Immunology Research!

✅ Contact LucidQuest at info@lqventures.com for strategic guidance on immunology breakthroughs and innovative therapies.

FAQ

What is tigulixostat and how does it compare to febuxostat in treating gout?

Tigulixostat demonstrated superior efficacy in lowering serum uric acid levels compared to febuxostat, with a favorable safety profile across all dose groups.

How does Yonsei University’s technique improve Crohn’s disease prognosis?

The technique allows for high-resolution mapping of gut bacteria and human gene expression, providing insights into the severity and recurrence of Crohn’s disease, enabling more precise and personalized treatments.

What are the key applications of MRM Health’s microbiome-based therapies?

The funding will support trials for MH002 in ulcerative colitis and other microbiome-based therapies targeting immune-oncology and inflammation, with a focus on advancing IND approval.

What is the goal of Boomerang Medical’s neuromodulation trial?

The trial aims to test the efficacy of sacral neuromodulation for managing ulcerative colitis symptoms, potentially providing a non-invasive alternative to current treatments.

What is Palisade Bio’s focus in Fibrostenotic Crohn’s Disease?

Palisade Bio is focusing on a novel treatment, PALI-2108, which has shown promising results in preclinical studies, targeting both inflammation and fibrosis in Fibrostenotic Crohn’s Disease.

Entities / Keywords

Tigulixostat (IBI128), Febuxostat, Crohn’s Disease (CD), Palisade Bio, MRM Health, Microbiome-based therapeutics, Boomerang Medical, Neuromodulation, Fibrostenotic Crohn’s Disease (FSCD), Hidradenitis Suppurativa (HS), Zoryve (Roflumilast Cream), Pediatric plaque psoriasis, Onco3R Therapeutics, SIK3 Inhibitor (O3R-5671), Inmedix, Neffy® (Epinephrine nasal spray), Anaphylaxis