Immunic Announces Publication of Data From Phase 1/1b Clinical Trial of IMU-856 in the Peer Reviewed Journal, The Lancet Gastroenterology & Hepatology
Immunic (NASDAQ: IMUX) announced the publication of its phase 1/1b clinical trial data for IMU-856 in The Lancet Gastroenterology & Hepatology. The trial evaluated IMU-856, an oral SIRT6 modulator, in healthy subjects and celiac disease patients. The study included 71 healthy subjects in Parts A and B, and 43 celiac disease patients in Part C. The trial demonstrated positive effects in four key areas: gut architecture protection, symptom improvement, biomarker response, and nutrient absorption enhancement. Both 80mg and 160mg doses were found to be safe and well-tolerated, with no serious adverse events reported. The treatment shows promise as a potential first-in-class oral therapy for celiac disease, which currently affects 1.4% of the global population.
Immunic (NASDAQ: IMUX) ha annunciato la pubblicazione dei dati del suo studio clinico di fase 1/1b per IMU-856 su The Lancet Gastroenterology & Hepatology. Lo studio ha valutato IMU-856, un modulator SIRT6 orale, in soggetti sani e in pazienti con celiachia. La ricerca ha incluso 71 soggetti sani nelle Parti A e B, e 43 pazienti con celiachia nella Parte C. La sperimentazione ha dimostrato effetti positivi in quattro aree chiave: protezione dell'architettura intestinale, miglioramento dei sintomi, risposta dei biomarcatori e miglioramento dell'assorbimento dei nutrienti. Sia le dosi da 80 mg che quelle da 160 mg sono risultate sicure e ben tollerate, senza eventi avversi gravi riportati. Il trattamento mostra potenziale come una possibile terapia orale di prima linea per la celiachia, che attualmente colpisce l'1,4% della popolazione globale.
Immunic (NASDAQ: IMUX) anunció la publicación de los datos de su ensayo clínico fase 1/1b para IMU-856 en The Lancet Gastroenterology & Hepatology. El ensayo evaluó IMU-856, un modulador oral de SIRT6, en sujetos sanos y pacientes con enfermedad celíaca. El estudio incluyó 71 sujetos sanos en las Partes A y B, y 43 pacientes con enfermedad celíaca en la Parte C. El ensayo demostró efectos positivos en cuatro áreas clave: protección de la arquitectura intestinal, mejora de los síntomas, respuesta de biomarcadores y mejora de la absorción de nutrientes. Ambas dosis de 80 mg y 160 mg resultaron seguras y bien toleradas, sin eventos adversos graves reportados. El tratamiento muestra promesas como una posible terapia oral de primera clase para la enfermedad celíaca, que actualmente afecta al 1.4% de la población mundial.
Immunic (NASDAQ: IMUX)는 IMU-856에 대한 1/1b 단계 임상 시험 데이터의 발표를 The Lancet Gastroenterology & Hepatology에 공표했다. 이 시험은 건강한 피험자와 셀리악병 환자에서 경구용 SIRT6 조절제인 IMU-856을 평가했다. 연구에는 A 및 B 파트에서 71명의 건강한 피험자와 C 파트에서 43명의 셀리악병 환자가 포함되었다. 시험 결과 긍정적인 효과가 입증되었다는 네 가지 주요 분야에서: 장 구조 보호, 증상 개선, 바이오마커 반응 및 영양소 흡수 개선. 80mg 및 160mg 용량 모두 안전하고 잘 견딜 수 있는 것으로 나타났으며, 중대한 이상 반응은 보고되지 않았다. 이 치료법은 현재 세계 인구의 1.4%에 영향을 미치는 셀리악병에 대한 잠재적인 1세대 경구 치료제로서의 가능성을 보여준다.
Immunic (NASDAQ: IMUX) a annoncé la publication des données de son essai clinique de phase 1/1b pour l'IMU-856 dans The Lancet Gastroenterology & Hepatology. L'essai a évalué l'IMU-856, un modulateur oral de SIRT6, chez des sujets sains et des patients atteints de la maladie coeliaque. L'étude a inclus 71 sujets sains dans les parties A et B, et 43 patients atteints de la maladie coeliaque dans la partie C. L'essai a démontré des effets positifs dans quatre domaines clés : protection de l'architecture intestinale, amélioration des symptômes, réponse des biomarqueurs et amélioration de l'absorption des nutriments. Les doses de 80 mg et 160 mg se sont révélées sûres et bien tolérées, sans événements indésirables graves signalés. Ce traitement montre un potentiel en tant que thérapie orale de première ligne pour la maladie coeliaque, qui touche actuellement 1,4% de la population mondiale.
Immunic (NASDAQ: IMUX) gab die Veröffentlichung seiner Phase 1/1b-Studienergebnisse für IMU-856 in The Lancet Gastroenterology & Hepatology bekannt. Die Studie bewertete IMU-856, einen oralen SIRT6-Modulator, bei gesunden Probanden und Patienten mit Zöliakie. Die Untersuchung umfasste 71 gesunde Probanden in den Teilen A und B sowie 43 Zöliakie-Patienten in Teil C. Die Studie zeigte positive Effekte in vier Schlüsselfeldern: Schutz der Darmarchitektur, Verbesserung der Symptome, Biomarker-Reaktion und Verbesserung der Nährstoffaufnahme. Sowohl die Dosen von 80 mg als auch 160 mg erwiesen sich als sicher und gut verträglich, ohne gemeldete schwerwiegende unerwünschte Ereignisse. Die Behandlung zeigt vielversprechende Ansätze als potenzielle orale Therapie der ersten Klasse bei Zöliakie, die derzeit 1,4% der Weltbevölkerung betrifft.
- Successful publication in prestigious peer-reviewed journal The Lancet Gastroenterology & Hepatology
- Positive clinical trial results showing improvements in four key celiac disease dimensions
- Favorable safety and tolerability profile with no serious adverse events
- Potential first-in-class oral therapy for celiac disease
- Possible expansion to other gastrointestinal diseases
- None.
Insights
The publication of IMU-856's Phase 1/1b trial data in The Lancet Gastroenterology & Hepatology represents significant clinical progress. The trial demonstrated meaningful improvements in four critical areas: histology, symptoms, biomarkers and nutrient absorption in celiac disease patients.
Key findings show that IMU-856, targeting SIRT6, was well-tolerated with no serious adverse events across both 80mg and 160mg doses. The drug's novel mechanism of action in modulating intestinal barrier function could represent a breakthrough in treating celiac disease, which affects
The successful completion of this early-stage trial with positive safety data and initial efficacy signals positions IMU-856 for advancement into later-stage trials. This could potentially lead to the first oral therapeutic option beyond the current standard of gluten-free diet management.
For a small-cap biotech with a market cap of
The company's strategic positioning in the gastrointestinal disease space, particularly targeting SIRT6, represents a novel approach that could attract partnership interest from larger pharmaceutical companies. The unmet need in celiac disease treatment, combined with the drug's oral administration and favorable safety profile, suggests substantial market potential if successfully developed.
– Includes Phase 1 Data in Healthy Human Subjects and Phase 1b Data in Celiac Disease Patients –
Dr. Daveson stated, "Celiac disease affects approximately
"The publication of our phase 1/1b clinical data in healthy human subjects and patients with celiac disease, in such a prestigious peer reviewed journal, confirms that IMU-856's novel mechanism modulating SIRT6, a protein which serves as a transcriptional regulator of intestinal barrier function and physiological regeneration of bowel epithelium, can represent an entirely new approach to treating gastrointestinal diseases," added Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "In our phase 1b clinical trial, IMU-856 showed the first clinical signals of its potential ability to restore a healthy gut by renewal of the gut wall, demonstrating meaningful improvements over placebo in four key dimensions of celiac disease pathophysiology: histology, disease symptoms, biomarkers and nutrient absorption. Together with a favorable safety and tolerability profile, it may set the stage for a potential first-in-class, oral celiac disease therapy. Additionally, we believe that this data provides initial clinical proof-of-concept for a potentially new, oral therapeutic approach to a range of gastrointestinal diseases with high unmet needs, beyond celiac disease."
The first two portions of the phase 1 clinical trial, Parts A and B, were single ascending dose and multiple ascending dose, double-blind, placebo-controlled studies in a total of 71 healthy human subjects. Single and multiple ascending doses of IMU-856 were found to be safe and well-tolerated, with no investigational medicinal product (IMP)-related serious or severe treatment-emergent adverse events. No maximum tolerated dose was reached in either part.
Part C was structured as a double-blind, randomized, placebo-controlled trial, designed to assess the safety and tolerability of IMU-856 in patients with celiac disease during periods of gluten-free diet and a 15-day gluten challenge with 6 g of gluten given daily. Further objectives included pharmacokinetics and initial clinical activity assessments, including malabsorption parameters, biomarkers for enterocyte functional mass, such as citrulline, disease-related symptoms as well as histological changes. The trial was conducted at sites in
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 and other intestinal barrier function associated diseases. Based on preclinical investigations demonstrating no suppression of immune cells, IMU-856 may have the potential to maintain immune surveillance for patients during therapy, which would be 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. 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), is currently in phase 3 and phase 2 clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis and moderate-to-severe ulcerative colitis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, for which it is currently in preparations for a phase 2 clinical trial. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. 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 and cash runway, expected timing, development 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; preclinical and clinical data for IMU-856; the timing of 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
Contact Information
Immunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com
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