IMU-856 / Daiichi Sankyo, Immunic - LARVOL DELTA

Anticipated Clinical Milestones (PRNewswire) - "Vidofludimus calcium in MS: Top-line data from the twin phase 3 ENSURE-1 and ENSURE-2 trials in RMS is expected by the end of 2026; IMU-856: The company is preparing for further clinical testing of IMU-856, the orally available and systemically acting small molecule modulator that targets Sirtuin 6 (SIRT6), contingent on financing, licensing or partnering."

New trial • P3 data: top line • Immunology • Multiple Sclerosis

BIOMARKERS OF EXTRACELLULAR MATRIX REMODELING REFLECT PHARMACODYNAMIC EFFECTS OF IMU-856, AN ORAL EPIGENETIC MODULATOR OF BARRIER REGENERATION (UEGW 2025) - "Biomarkers of ECM remodeling reflect histological inflammation and mucosal architecture parameters such as Q-Marsh score and villus height, offering a direct insight into intestinal barrier integrity. Furthermore, these biomarkers potentially reflect treatment-induced improvement in intestinal tissue remodeling upon treatment with IMU-856."

Biomarker • PK/PD data • Celiac Disease • Immunology • Inflammation • Inflammatory Bowel Disease • SIRT6

IMU-856, AN ORALLY AVAILABLE EPIGENETIC MODULATOR OF BARRIER REGENERATION, SHOWED POSITIVE EFFECTS ON GUT HORMONE LEVELS IN CELIAC DISEASE PATIENTS IN A PHASE 1 CLINICAL STUDY (UEGW 2025) - "IMU-856 is a safe, highly selective and potent epigenetic modulator, improving the intestinal barrier function in patients with celiac disease undergoing a gluten challenge.Positive effects of IMU-856 on gut hormones and various biomarkers for overall gut health including intestinal function and integrity were observed. Therefore, IMU-856 may offer extensive potential for treatment of gastrointestinal diseases with compromised intestinal barrier function and metabolic diseases."

Clinical • P1 data • Celiac Disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Metabolic Disorders • SIRT6

Is There a Future Without Gluten Restrictions for Celiac Patients? Update on Current Treatments. (PubMed, Nutrients) - "These include gluten-degrading enzymes (e.g., AN-PEP, Latiglutenase, Zamaglutenase), gluten-sequestering agents (e.g., AGY-010, BL-7010), modulators of intestinal permeability (e.g., Larazotide acetate, IMU-856), immune-modulating agents (e.g., ZED1227, AMG 714, EQ102), and strategies for immune tolerization (e.g., TAK-101, KAN-101, Nexvax2). Continued research is essential to validate efficacy, optimize dosing, and ensure safety in broader patient populations. Here, we provide a comprehensive overview of the therapeutic landscape for CeD, analyze the main strengths and limitations of each treatment and highlight promising directions for future management of CeD, altogether evidencing the urgent need to develop effective alternatives for these patients."

Journal • Review • Allergy • Celiac Disease • Immunology

Coeliac disease and the intestinal barrier: mechanisms of disruption and strategies for restoration. (PubMed, Gut) - "We also review comprehensively the therapies targeting barrier integrity and normalising intestinal permeability, including particular diets and supplements, and experimental and improved medications including larazotide acetate and IMU-856. Finally, we highlight the need for reliable biomarkers for evaluating increased permeability in coeliac disease and advocate for further research on therapies which normalise barrier function, particularly as a strategy to maintain remission."

Journal • Review • Celiac Disease • Gastrointestinal Disorder • Immunology

IMU-856 VS PLACEBO EFFICACY EFFECTS IN CELIAC PATIENTS ARE INDEPENDENT OF Q-MARSH SCALE AT BASELINE (DDW 2025) - "This Phase 1b clinical trial in celiac patients shows no evidence of the Q-Marsh score having an impact on to the ability of IMU-856 to influence celiac disease-related efficacy outcomes and biomarkers, indicating that effect of IMU-856 is independent of the Q-Marsh score at baseline."

Clinical • Celiac Disease • Immunology

INFLUENCE OF GUT ENDOTHELIAL CONDITION ON THE PHARMACOKINETIC PROPERTIES OF IMU-856, AN ORAL REGULATOR OF BARRIER FUNCTION FOR THE TREATMENT OF CELIAC DISEASE (DDW 2025) - "The analysis found similar systemic exposure following oral administration of IMU-856 in patients with celiac disease with various degrees of gut epithelial damage as in healthy human volunteers. This is indicative that IMU-856 is able to reach the systemic circulation in therapeutically relevant amounts independent of the severity of epithelial damage as a result of celiac disease."

PK/PD data • Celiac Disease • Immunology

Immunic to Participate in Scientific and Industry Conferences in May (PRNewswire) - "May 3-6: Digestive Disease Week (DDW). Two abstracts discussing Immunic's phase 1/1b clinical trial of IMU-856, an orally available and systemically acting small molecule modulator that targets SIRT6 (Sirtuin 6), in patients with celiac disease, have been accepted for poster presentations at this conference in San Diego, CA....May 28-31: Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting 2025. Members of Immunic's management, medical and preclinical teams will attend this meeting in Phoenix, AZ. The team will be available throughout the event at booth #911. Additionally, preclinical data highlighting lead asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), will be presented in a poster presentation."

P1 data • Preclinical • Celiac Disease • Multiple Sclerosis

Promising effects of IMU-856, an orally available epigenetic modulator of barrier regeneration - biomarker findings from a Phase 1 clinical study (ECCO-IBD 2025) - "Treatment with IMU-856 improved the mass, metabolic function and health of intestinal enterocytes as measured by nutrient uptake as well as several biomarkers for intestinal function and integrity as well as general gut health [1]. Conclusion IMU-856 is a safe, highly selective and potent epigenetic modulator, showing signals of improving the intestinal barrier function in patients with celiac disease undergoing a gluten challenge.The positive effects of IMU-856 on various biomarkers for intestinal function, overall health and integrity in conjunction with the protection of gut architecture show that IMU-856 may offer extensive potential in other gastrointestinal diseases with compromised intestinal barrier function like IBD."

Biomarker • Clinical • P1 data • Inflammatory Bowel Disease • SIRT6

Immunic's Oral IMU-856 Demonstrated Dose-Dependent Increase of GLP-1 in Celiac Disease Patients and Corresponding Effects in Preclinical Testing (PRNewswire) - "New data is available from a post hoc analysis of the company's phase 1b clinical trial of IMU-856 in celiac disease patients, where blood concentrations of GLP-1 were measured, between baseline and day 28, in a fasting state. A highly statistically significant (day 29: 80 mg p=0.014; 160 mg p=0.003) and dose-dependent increase of GLP-1 versus placebo control was detectable, even in the small patient population in this phase 1b clinical trial (baseline: N placebo = 11, N 80 mg IMU-856 = 13, N 160 mg IMU-856 = 13). These clinical findings were corroborated by effects observed in a 6-month preclinical in vivo study, where IMU-856 was found to reduce body weight gain accompanied by food consumption in a dose-dependent fashion up to -40 %, compared to the control group, which was found to be linked to reduced food intake."

P1 data • Preclinical • Celiac Disease • Metabolic Disorders

Preclinical characterization of IMU-856, an orally available epigenetic modulator of gut barrier function and regeneration (ECCO-IBD 2025) - "No effects of IMU-856 on T-cell proliferation and cytokine secretion (interferon-g (IFN-g)) were observed in human PBMCs. Conclusion IMU-856 data indicate restoration of intestinal barrier function and promotion of physiological mucosal regeneration without direct immunosuppressive effects and may therefore offer potential for the treatment of IBD and other gastrointestinal diseases with compromised barrier function."

Preclinical • Inflammatory Bowel Disease • IFNG • SIRT6

Immunic to Participate in Investor and Scientific Conferences in February (PRNewswire) - "Immunic, Inc...announced participation in the following investor and scientific conferences in February: 1] February 10-11: BIO CEO & Investor Conference 2025. 2] February 11-12: Oppenheimer 35th Annual Healthcare Life Sciences Conference. 3] February 19-22: 19th Congress of ECCO (European Crohn's and Colitis Organisation). 4] February 25-27: 7th Neuroimmunology Drug Development Summit. 5] February 27 - March 1: Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2025."

Clinical data • Multiple Sclerosis

Safety, clinical activity, pharmacodynamics, and pharmacokinetics of IMU-856, a SIRT6 modulator, in coeliac disease: a first-in-human, randomised, double-blind, placebo-controlled, phase 1 trial. (PubMed, Lancet Gastroenterol Hepatol) - P1 | "The favourable safety profile, along with preliminary activity, suggests that IMU-856 should be studied in future trials of coeliac disease."

Clinical • Journal • P1 data • PK/PD data • Cardiovascular • Celiac Disease • Immunology • Inflammation • Pain • SIRT6

FIRST IN HUMAN TRIAL OF IMU-856, AN ORALLY AVAILABLE EPIGENETIC MODULATOR OF BARRIER REGENERATION FOR THE TREATMENT OF CELIAC DISEASE (DDW 2024) - "IMU-856 is a safe, highly selective and potent epigenetic modulator, showing first signals of improving the intestinal barrier function in patients with celiac disease undergoing a gluten challenge. Phase 1b provided proof of concept data for IMU-856 in patients with celiac disease during periods of gluten-free diet and 15-days gluten challenge, setting stage for a potential first-in-class oral celiac disease therapy. IMU-856 may offer extensive potential beyond celiac disease in other diseases, both intestinal and systemic, with compromised intestinal barrier function."

P1 data • Celiac Disease • Gastrointestinal Disorder • Immunology

Immunic, Inc. Reports First Quarter 2024 Financial Results and Provides Corporate Update (PRNewswire) - "Research and Development (R&D) Expenses were $18.7 million for the three months ended March 31, 2024, as compared to $22.9 million for the three months ended March 31, 2023. The $4.2 million decrease reflects (i) a decrease of $2.4 million from deprioritizing the izumerogant program in psoriasis and castration-resistant prostate cancer and (ii) a $2.5 million decrease in external development costs related to the vidofludimus calcium and IMU-856 programs."

Commercial • Castration-Resistant Prostate Cancer • Crohn's disease • Genito-urinary Cancer • Immunology • Inflammatory Bowel Disease • Multiple Sclerosis • Oncology • Prostate Cancer • Psoriasis • Rheumatoid Arthritis • Solid Tumor • Ulcerative Colitis

Immunic, Inc. Announces Private Placement of up to $240 Million (Yahoo Finance) - "Immunic, Inc...announced it has entered into a securities purchase agreement with select accredited investors to purchase shares of common stock (or pre-funded warrants in lieu thereof) in a three-tranche offering....The Company intends to use the net proceeds from the private placement to fund the ongoing clinical development of its three lead product candidates, vidofludimus calcium (IMU-838), IMU-856 and IMU-381, and for other general corporate purposes."

Financing • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

FIRST IN HUMAN TRIAL OF IMU-856, AN ORALLY AVAILABLE EPIGENETIC MODULATOR OF BARRIER REGENERATION FOR THE TREATMENT OF CELIAC DISEASE (UEGW 2023) - "IMU-856 is a highly selective and potent epigenetic modulator, showing first signals of improving the intestinal barrier function in patients with celiac disease undergoing a gluten challenge. IMU-856 was safe and well-tolerated with a benign adverse event profile and with pharmacokinetics that allow once-daily dosing. Phase 1b provided proof of concept data for IMU-856 in patients with celiac disease during periods of gluten-free diet and 15-days gluten challenge, setting stage for a potential first-in-class oral celiac disease therapy."

P1 data • Celiac Disease • Gastrointestinal Disorder • Immunology • Inflammation • IL2 • SIRT6

A three-part, double-blind, placebo-controlled, Phase I/Ib study of the safety, tolerability and pharmacokinetics of single and multiple ascending doses of IMU-856 in healthy volunteers and patients with Celiac disease (ANZCTR) - P1 | N=120 | Completed | Sponsor: Immunic Australia Pty Ltd | Recruiting ➔ Completed

Trial completion • Celiac Disease • Gastrointestinal Disorder • Immunology • TGM2

Immunic, Inc. Reports First Quarter 2023 Financial Results and Provides Corporate Update (PRNewswire) - "Anticipated Clinical Milestones: Vidofludimus calcium in MS: As previously announced, data from the interim analysis of the phase 2 CALLIPER trial of vidofludimus calcium in progressive MS is expected to be available in the second half of 2023 and top-line data at the end of 2024. Moreover, data from the interim analysis of the ENSURE program is expected in late 2024, with the read-out of the first of the ENSURE trials at the end of 2025. IMU-856 in celiac disease: Based on positive data from the phase 1b clinical trial, testing IMU-856 in celiac disease patients during periods of gluten-free diet and gluten challenge, the company is actively preparing for clinical phase 2b testing of IMU-856 in ongoing active celiac disease."

New P2b trial • P2 data • Celiac Disease • Immunology • Multiple Sclerosis

FIRST IN HUMAN TRIAL OF IMU-856, AN ORALLY AVAILABLE REGULATOR OF BARRIER FUNCTION FOR THE TREATMENT OF CELIAC DISEASE (DDW 2023) - "IMU-856 was safe and well-tolerated with a benign adverse event profile in healthy volunteers and with pharmacokinetics that allow once-daily dosing. Phase 1b will provide data for IMU-856 in patients with well-controlled celiac disease during periods of gluten-free diet and gluten challenge."

P1 data • Celiac Disease • Immunology

Immunic to Participate in Investor and Scientific Conferences in May (PRNewswire) - "Immunic, Inc...announced participation in the following investor and scientific conferences in May:...May 6-9: Digestive Disease Week 2023. Franziska Buriánek, M.D., Senior Medical Director at Immunic, will present phase 1 clinical data of IMU-856 in healthy human subjects in a virtual e-poster at this conference in Chicago, IL."

P1 data • Celiac Disease • Immunology

Immunic, Inc. Reports Year End 2022 Financial Results and Provides Corporate Update (PRNewswire) - "Research and Development (R&D) Expenses were $71.3 million for the twelve months ended December 31, 2022, as compared to $61.1 million for the twelve months ended December 31, 2021. The $10.1 million increase reflects (i) a $18.4 million increase in external development costs related to the ongoing clinical programs of vidofludimus calcium in relapsing and progressive MS, as well as izumerogant and IMU-856, and (ii) a $2.5 million increase in personnel expense in research and development, $1.5 million of which is related to non-cash stock compensation expense. The increases were partially offset by (i) a decrease of $10.1 million in external development costs related to the clinical trials of vidofludimus calcium in ulcerative colitis..."

Commercial • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Immunic, Inc. Announces $60.0 Million Oversubscribed Private Placement Equity Financing (PRNewswire) - "Immunic, Inc...announced it has entered into a securities purchase agreement (the 'Purchase Agreement') with select accredited investors and certain existing investors to issue and sell an aggregate of 8,696,552 shares of its common stock ('Common Stock') at a price of $4.35 per share, reflecting a 10% premium to the closing price on October 7, 2022 on NASDAQ, and pre-funded warrants ('Pre-Funded Warrants') to purchase up to an aggregate of 5,096,552 shares of Common Stock at a purchase price of $4.34 per pre-funded warrant share, through a private investment in public equity ('PIPE') financing....The Company intends to use net proceeds from the financing to fund the ongoing clinical development of its three lead product candidates, vidofludimus calcium (IMU-838), IMU-935 and IMU-856, and for other general corporate purposes."

Commercial • Immunology • Inflammatory Bowel Disease

Immunic Announces Positive Results from Single and Multiple Ascending Dose Parts of Its Phase 1 Clinical Trial of IMU-856 in Healthy Human Subjects (PRNewswire) - P1 | N=NA | "Immunic, Inc...announced positive unblinded safety, tolerability and pharmacokinetic (PK) results from Part A (single ascending doses, SAD) and Part B (multiple ascending doses, MAD) of its phase 1 clinical trial of IMU-856 in healthy human subjects....Single ascending doses of IMU-856 were found to be safe and well-tolerated and no maximum tolerated dose was reached. No serious adverse events occurred. Moreover, a dose-linear PK profile was observed across the investigated dose range....Multiple ascending doses of IMU-856 were found to be safe and well-tolerated and no maximum tolerated dose was reached."

P1 data • Immunology • Inflammatory Bowel Disease

Immunic Receives Notice of Allowance for Composition-of-Matter Patent in the United States for IMU-856, a Small Molecule Modulator Targeting Restoration of Intestinal Barrier Function and Regeneration of Bowel Epithelium (PRNewswire) - "Immunic, Inc...announced that the company has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for patent application 16/646130, entitled, 'Compound Having Cyclic Structure.' The patent covers composition-of-matter of IMU-856 and related pharmaceutical compositions and is expected to provide protection into at least 2038, without accounting for potential Patent Term Extension (PTE)."

Patent • Immunology • Inflammatory Bowel Disease