Core Insights - Duvakitug, an investigational human monoclonal antibody targeting TL1A, has shown durable clinical and endoscopic efficacy in patients with ulcerative colitis (UC) and Crohn's disease (CD) over a 44-week maintenance period following initial response in the induction phase [1][7] - The study results indicate that duvakitug has the potential to be a leading therapy for inflammatory bowel disease (IBD), with ongoing phase 3 studies to further evaluate its efficacy and safety [2][4] Study Details - The RELIEVE UCCD long-term extension study enrolled 130 patients who had responded to duvakitug in the induction study, with a maintenance period of 44 weeks where patients received either 450 mg or 900 mg doses every four weeks [2][12] - At week 44, 58% of patients on the 900 mg dose and 47% on the 450 mg dose achieved clinical remission in UC, while 55% on the 900 mg dose and 41% on the 450 mg dose achieved endoscopic response in CD [8] Safety and Tolerability - Both doses of duvakitug were well tolerated, with the most common adverse events being upper respiratory tract infection, nasopharyngitis, Crohn's disease, and hypertension, consistent with findings from the induction study [3][7] Industry Context - IBD is characterized by chronic inflammation of the gastrointestinal tract, with approximately 4.9 million cases globally, and the incidence is rising in several regions [5] - There is currently no cure for IBD, and treatment aims to induce and maintain remission while preventing flares [9]

Core Insights - Palisade Bio has appointed Dr. Laurent Peyrin-Biroulet and Dr. David T. Rubin to its Clinical Advisory Board, enhancing its clinical strategy as it advances PALI-2108 towards Phase 2 development in ulcerative colitis and fibrostenotic Crohn's disease [1][2] Company Overview - Palisade Bio, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation oral PDE4 inhibitor prodrugs aimed at targeted delivery to the terminal ileum and colon [1][10] - The lead program, PALI-2108, is designed for once-daily oral administration and is pharmacologically inactive until it reaches the lower intestine, where it is activated by bacterial enzymes [9][11] Clinical Development - PALI-2108 has shown a 100% clinical response in a Phase 1b trial for ulcerative colitis, with no serious adverse events reported [11] - The company plans to submit an IND for a Phase 2 clinical study in ulcerative colitis in the first half of 2026, focusing on clinical remission and pharmacodynamic biomarkers over a 12-week period [1][12] Advisory Board Expertise - Dr. Peyrin-Biroulet is a leading authority in inflammatory bowel disease, with over 1200 peer-reviewed publications and significant roles in major IBD organizations [4][5] - Dr. Rubin is recognized for his expertise in clinical trial design and has been instrumental in the development of numerous approved IBD therapies [7][8]

Company Overview - Shattuck Labs is a clinical-stage biotechnology company focused on developing novel therapeutics for inflammatory and immune-mediated diseases[5] - The lead program, SL-325, is a potential first-in-class blocking antibody targeting DR3 for the treatment of inflammatory bowel disease (IBD)[5] - The company had $86.1 million in cash and cash equivalents as of September 30, 2025, with a cash runway expected to last into 2029[5] SL-325 Program and TL1A/DR3 Pathway - SL-325 has picomolar binding affinity (1.3 pM) to DR3 and overlaps the TL1A binding site[44] - SL-325 is designed for potent DR3 blockade and does not bind to DcR3[44] - Preclinical data suggests SL-325 blocks TL1A binding at lower concentrations than benchmark anti-TL1As, with approximately 10-fold greater potency in vitro[52] - In non-human primate studies, SL-325 achieved full and durable receptor occupancy (RO) at all dose levels for at least four weeks post-dose[60] Market and Milestones - Worldwide inflammatory bowel disease (IBD) sales are expected to reach $33.3 billion by 2030[22, 76] - Enrollment is ongoing in a Phase 1 clinical trial evaluating SL-325 in healthy volunteers, with completion expected in Q2 2026[5, 76]

EQ504: A Novel AhR Modulator for Ulcerative Colitis - Equillium, Inc is developing EQ504, a novel aryl hydrocarbon receptor (AhR) modulator for ulcerative colitis [1] - EQ504 is derived from ITE, a naturally-occurring, endogenous, non-toxic AhR modulator synthesized in the gut & lungs, and is a highly potent and selective modulator of AhR [143][144] - EQ504 has a multi-modal mechanism of action in mucosal homeostasis, modulating immune cell responses and promoting barrier function & tissue repair [148][149][150] - In vitro, EQ504 increases the number and function of suppressive Treg cells that inhibit activity of Th1 and Th17 cells and promote tissue homeostasis [156] - In a DSS colitis animal model, EQ504 blocks weight loss and induces anti-inflammatory cytokines in colon tissue [158][160] Clinical Validation and Market Opportunity - Modulation of AhR has been clinically validated in skin diseases, with up to 34% of patients achieving a PGA-Pso score of 0-1 by week 12 in psoriasis and up to 34% of patients achieving a vIGA-AD score of 0-1 by week 8 in atopic dermatitis [134][136] - Phase 2 trials of Indigo Naturalis in ulcerative colitis showed up to 50% of patients achieved clinical remission with total Mayo score ≤ 2, no individual subscore > 1, and up to 27% of treatment refractory patients achieved clinical remission with total Mayo score < 3, no individual subscore > 1 [138] - Studies of ulcerative colitis patients treated with indigo naturalis demonstrate on-target engagement of AhR through increased intestinal CYP1A1 and high levels of clinical remission [142] - In vivo experiments demonstrate localized delivery of EQ504 directly to the colon of rats, results in >25X greater peak exposures in colon tissues versus blood [167] - The US market for ulcerative colitis treatments is approximately $6 billion, with a substantial unmet need for new oral agents in the pre-biologic setting and opportunities in biologic failure patients and combination therapy [172][173]

Core Insights - Spyre Therapeutics announced positive interim Phase 1 results for SPY003, an investigational extended half-life antibody targeting IL-23, which supports its potential for quarterly or biannual maintenance dosing [1][2][8] Group 1: Clinical Trial Results - SPY003 demonstrated a favorable safety profile in a Phase 1 trial with 59 healthy adult participants, showing it was well tolerated across all dose levels [3][5] - The trial included various dosing cohorts, with the most common treatment-emergent adverse event being headache, and no serious adverse events reported [3][4] - SPY003 exhibited a half-life of approximately 85 days, significantly longer than risankizumab, indicating potential for less frequent dosing [5][8] Group 2: Future Development Plans - The positive results from the Phase 1 trial will allow SPY003 to advance to the ongoing Part A of the SKYLINE Phase 2 platform trial [1][2] - The SKYLINE and SKYWAY trials are expected to yield six proof-of-concept readouts by 2026, further validating the efficacy and safety of SPY003 [1][2] Group 3: Company Overview - Spyre Therapeutics is focused on developing long-acting antibodies and antibody combinations to improve treatment standards for inflammatory bowel disease (IBD) and rheumatic diseases [9] - The company’s pipeline includes investigational therapies targeting α4β7, TL1A, and IL-23, aiming to create a comprehensive IBD portfolio [2][9]

Core Insights - Eli Lilly and Company announced FDA approval for a single-injection, once-monthly maintenance regimen of Omvoh (mirikizumab-mrkz) for adults with moderately to severely active ulcerative colitis, set to be available in early 2026 [1][2][4] Product Details - Omvoh's single-injection dosing replaces the previous two-injection regimen, simplifying the maintenance experience for patients [1][2] - The new formulation is citrate-free and will be available via prefilled pen or syringe [2] - Omvoh is already approved for Crohn's disease and has received three FDA approvals in 2025 [1][4] Clinical Significance - The approval is based on a Phase 1 study demonstrating that the single-injection is bioequivalent to the two-injection regimen, confirming its efficacy [3] - The treatment protocol begins with 300 mg IV infusions every four weeks for three infusions, transitioning to subcutaneous self-injection every four weeks for maintenance [3][15] Market Position - Omvoh is approved in the U.S. for both ulcerative colitis and Crohn's disease, with approvals in 45 countries globally [4][20] - Eli Lilly emphasizes its commitment to improving treatment experiences for patients with inflammatory bowel disease (IBD) [4][21]

Core Viewpoint - AbbVie announced the FDA approval of a supplemental new drug application (sNDA) for RINVOQ (upadacitinib), allowing its use in adults with moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD) after one approved systemic therapy when TNF blockers are clinically inadvisable [1][2]. Group 1: Product Information - RINVOQ is now indicated for patients with moderately to severely active UC or CD who have had an inadequate response or intolerance to one or more TNF blockers, and can be prescribed after one approved systemic therapy if TNF blockers are not suitable [2]. - RINVOQ is a JAK inhibitor developed by AbbVie, which is being studied for various immune-mediated inflammatory diseases [9][10]. Group 2: Patient Support and Access - AbbVie offers a patient support program and a co-pay card that may reduce out-of-pocket costs to $0 per month for eligible, commercially insured patients [5]. - The company has a Patient Assistance Program, myAbbVieAssist, for uninsured patients or those unable to afford their medication [5]. Group 3: Company Commitment - AbbVie is dedicated to addressing the needs of patients with inflammatory bowel disease (IBD), aiming to alleviate the physical, emotional, and economic burdens associated with UC and CD [2][8]. - The company is committed to innovative research in gastroenterology, focusing on developing treatments for IBD [32].

Core Insights - The discussion focuses on the UEGW conference in Berlin, highlighting significant updates in the Inflammatory Bowel Disease (IBD) sector [1]. Group 1: Conference Overview - The UEGW conference was described as exciting, with numerous updates relevant to the IBD space [1]. - The session is part of the Wedbush Rewind series, aimed at reviewing key highlights from industry conferences [1]. Group 2: Participants - Key participants include David Nierengarten, Managing Director of the Healthcare Equity Research team at Wedbush, Dr. Marla Dubinsky from Mount Sinai, David De Vries M. Phil, CEO of Tr1X Bio, and Taylor Schreiber, MD, PhD, CEO of Shattuck Labs [2]. - The format encourages audience participation through a Q&A session, enhancing engagement during the discussion [3].

Core Insights - Spyre Therapeutics reported positive interim Phase 1 results for two next-generation TL1A antibodies, indicating they were well-tolerated and supported quarterly or biannual dosing with full TL1A engagement for up to 20 weeks [1][2] - The company initiated the Phase 2 SKYLINE-UC platform study to evaluate three optimized monotherapies and three potentially paradigm-changing combinations for ulcerative colitis [1][3] - Spyre is on track to begin the Phase 2 SKYWAY-RD basket study for TL1A inhibition in rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis in Q3 2025 [1][10] - The company has a strong cash position of $526.6 million as of June 30, 2025, with an expected runway into the second half of 2028 [1][11] Development Pipeline Overview - Spyre's approach combines advanced antibody engineering, dose optimization, and rational therapeutic combinations to enhance efficacy and convenience in treating inflammatory bowel disease (IBD) and other immune-mediated diseases [3][15] - IBD affects approximately 2.4 million individuals in the U.S., while rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) affect over 1.5 million and nearly 3 million individuals, respectively [3][4] Financial Performance - Research and Development (R&D) expenses for Q2 2025 totaled $40.1 million, up from $32.6 million in Q2 2024, primarily due to increased clinical trial expenses [12] - General and Administrative (G&A) expenses were $11.8 million for Q2 2025, slightly higher than $11.5 million in Q2 2024 [12] - The net loss for Q2 2025 was $36.7 million, compared to a net loss of $38.8 million in Q2 2024, including non-cash stock-based compensation expenses [14][24]

Core Insights - Ventyx Biosciences is a clinical-stage biopharmaceutical company focused on developing innovative oral therapies for autoimmune, inflammatory, and neurodegenerative diseases [8] Pipeline Updates and Anticipated Milestones - Ventyx is advancing two novel NLRP3 inhibitors, VTX3232 and VTX2735, through Phase 2 trials targeting neurodegenerative, cardiovascular, and metabolic diseases [2] - The Phase 2 biomarker trial for VTX3232 in Parkinson's disease is expected to complete in Q2 2025, with key endpoints including safety and pharmacokinetics [3] - Results from the Phase 2 trial of VTX3232 in obesity and cardiometabolic risk factors, as well as VTX2735 in recurrent pericarditis, are anticipated in the second half of 2025 [3][4] Financial Overview - As of March 31, 2025, Ventyx reported cash, cash equivalents, and marketable securities of $228.8 million, sufficient to fund operations into at least H2 2026 [11][17] - Research and Development (R&D) expenses for Q1 2025 were $22.9 million, down from $33.7 million in Q1 2024 [11] - General and Administrative (G&A) expenses decreased to $7.2 million in Q1 2025 from $8.0 million in Q1 2024 [11] - The net loss for Q1 2025 was $27.4 million, compared to a net loss of $38.6 million in Q1 2024 [11][15] Inflammatory Bowel Disease (IBD) Portfolio - Ventyx's IBD portfolio includes two Phase 2 compounds: tamuzimod (VTX002), an S1P1R modulator, and VTX958, a TYK2 inhibitor [9] - Tamuzimod has shown robust clinical and endoscopic remission rates compared to placebo, positioning it as a potential backbone for future combination therapies in ulcerative colitis [11] - VTX958 demonstrated a dose-dependent endoscopic response in Crohn's disease, suggesting potential disease-modifying benefits [11]