News Press Releases

Immunic Presents Clinical and Preclinical Data for IMU-856 at Digestive Disease Week 2023, Including Its Molecular Mode of Action

IMUX | May 6, 2023

– IMU-856 is an Orally Available, Systemically Acting, Highly Selective and Potent Small Molecule Modulator of SIRT6 –

– Targets Regeneration of Bowel Epithelium and Restoration of Intestinal Barrier Function –

– Builds on Recently Released Phase 1b Data Showing Beneficial Effects in Celiac Disease Histology, Disease Symptoms, Biomarkers and Nutrient Absorption –

– Virtual ePoster to be Presented Today, May 6, 2023, During 9:30 am - 4:00 pm CT Poster Session –

NEW YORK, May 6, 2023 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced the presentation of clinical and preclinical data for IMU-856. Included in this presentation are new data on IMU-856's mode of action as a potent modulator of SIRT6 (Sirtuin 6), a protein which serves as a transcriptional regulator of intestinal barrier function and regeneration of bowel epithelium. The presentation will be held as a virtual e-poster at Digestive Disease Week (DDW) 2023, currently underway through Tuesday, May 9, 2023, both virtually and in-person, in Chicago, IL.

IMU-856 is a highly selective and potent small molecule which has been shown to modulate, stabilize and enhance expression of the SIRT6 protein, in particular, in the gastrointestinal tract. In the small intestine, SIRT6 expression is highest among absorptive enterocytes which are responsible for nutrient uptake, mucus-producing goblet cells which protect the wall's lining, and Paneth cells which support, protect and stimulate local regenerative stem cells. Modulation of these cell types by IMU-856 appears to direct local stem cells to divide and then differentiate into 'new' intestinal epithelial cells, thereby stimulating the natural physiologic process of renewal of the gut wall lining.

In both animal and early clinical studies, IMU-856 has been shown to restore and renew the intestinal lining. In a preclinical DSS (dextran sodium sulfate) colitis model, IMU-856 treatment protected and also improved regeneration of the gut lining, as measured by normalization of crypt architecture. IMU-856 treatment also induced a dose-dependent tightening of the intestinal barrier, as measured by TEER (transepithelial electrical resistance) assay. Gene expression experiments revealed that this latter effect can at least be partially attributed to the upregulation of barrier forming claudin-1 and the downregulation of channel forming claudin-2. Finally, data from Immunic's phase 1b clinical trial of IMU-856, summarized in the company's May 4, 2023 press release, also corroborated these findings in a proof-of-concept trial in celiac disease patients. Immunic reported that IMU-856 treatment showed beneficial effects in four key dimensions of celiac disease pathophysiology: histology, disease symptoms, biomarkers and nutrient absorption. The observed effects included, not only protecting the gut against effects of the gluten challenge, but also highlighted improvements in gut health which are relevant to celiac disease and to other gastrointestinal diseases. The consistent signals of IMU-856 treatment in this trial, as compared to placebo, seem to support clinical proof for the regeneration and renewal of the bowel wall.

"By restoring intestinal barrier function and bowel wall architecture through its effect on SIRT6, IMU-856 may offer a unique treatment option for patients suffering from gastrointestinal diseases," stated Hella Kohlhof, Ph.D., Chief Scientific Officer of Immunic. "Of particular interest, in preclinical studies, IMU-856 was shown to avoid suppression of immune cells and may therefore maintain immune surveillance for patients during therapy, representing a distinct advantage when compared with chronic administration of potentially immunosuppressive medications. Additionally, our preclinical studies showed that treatment with IMU-856 results in two important effects. First, the SIRT6 protein is stabilized, and second, de-acetylation of target structures by SIRT6 is prevented, leading to a regenerative phenotype."

"Coming on the heels of the positive data we reported for our phase 1b clinical trial of IMU-856 in celiac disease, the presentation of earlier-stage findings at DDW, including announcing, for the first time, the mode of action of IMU-856, is an important step in our continued development process for this novel therapeutic," added Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "As recently reported, celiac disease patients treated with IMU-856 in the proof-of-concept trial showed a meaningful improvement in a wide array of key histologic, symptomatic, nutritional and immunologic parameters during gluten challenge, while IMU-856 continued to show a clean safety and tolerability profile. IMU-856 may also offer extensive potential beyond celiac disease including serious and widely prevalent gastrointestinal diseases with high unmet needs such as ulcerative colitis, Crohn's disease, or irritable bowel syndrome with diarrhea, all of which are characterized by compromised intestinal barrier function. That said, we are preparing for a phase 2b clinical trial of IMU-856 in celiac disease patients, while also considering other indications."

Poster Details
Franziska Buriánek, M.D., Senior Medical Director at Immunic, will present data from the single and multiple ascending dose portions of the phase 1 clinical trial of IMU-856 in healthy human subjects as well as preclinical data on IMU-856, including its mode of action, in a virtual e-poster at DDW 2023.

Title:First-in-Human Trial of IMU-856, an Orally Available Regulator Of Barrier Function For The Treatment Of Celiac Disease
ePoster Number: EP63
Session: AGA Celiac Disease and Gluten Related Disorders
Date: Saturday, May 6, 2023
Time:9:30 am - 4:00 pm CT (10:30 am - 5:00 pm ET)

The poster is accessible on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations.

About IMU-856
IMU-856 is an orally available and systemically acting small molecule modulator that targets SIRT6 (Sirtuin 6), a protein which serves as a transcriptional regulator of intestinal barrier function and regeneration of bowel epithelium. Based on preclinical data, the compound may represent a unique treatment approach, as the mechanism of action targets the restoration of the intestinal barrier function and bowel wall architecture in patients suffering from gastrointestinal diseases such as celiac disease, inflammatory bowel disease, irritable bowel syndrome with diarrhea and other intestinal barrier function associated diseases. Immunic believes that, because IMU-856 has been shown in preclinical investigations to avoid suppression of immune cells, it may therefore have the potential to maintain immune surveillance for patients during therapy, an important advantage versus immunosuppressive medications. IMU-856 demonstrated positive results in a phase 1b clinical trial in celiac disease patients in four key dimensions of the disease's pathophysiology: histology, disease symptoms, biomarkers and nutrient absorption. Currently, the company is preparing for phase 2 clinical testing in this patient population. IMU-856 is an investigational drug product that has not been approved in any jurisdiction.

About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The company's lead development program, vidofludimus calcium (IMU-838), currently in phase 3 clinical trials for the treatment of multiple sclerosis and which has shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis and moderate-to-severe ulcerative colitis, selectively inhibits activated immune cells and shows combined anti-inflammatory, anti-viral and neuroprotective effects. IMU-856 is targeted to restore intestinal barrier function and regenerate bowel epithelium, which would be applicable in numerous gastrointestinal diseases, such as celiac disease, where it is currently in preparations for a phase 2 clinical trial. For further information, please visit: www.imux.com.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash, expected development, timing and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for IMU-856 to safely and effectively target diseases; the potential for IMU-856 to have applicability in the treatment of other gastrointestinal diseases; interpretation of preclinical and clinical data for IMU-856 and potential effects including the phase 1b clinical results of IMU-856; plans for phase 2 clinical testing of IMU-856 and the timing of other current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the COVID-19 pandemic, increasing inflation, impacts of the Ukraine – Russia conflict on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the SEC on February 23, 2023, and in the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release.

Contact Information

Immunic, Inc.
Jessica Breu
Head of Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com

US IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.com

US Media Contact
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Edna Kaplan
+1 617 974 8659
kaplan@kogspr.com