Immunic's Oral IMU-856 Demonstrated Dose-Dependent Increase of GLP-1 in Celiac Disease Patients and Corresponding Effects in Preclinical Testing
Immunic (NASDAQ: IMUX) announced new data showing that IMU-856, their oral SIRT6 modulator, demonstrated promising results for potential weight management applications. A post hoc analysis of their phase 1b celiac disease trial revealed a dose-dependent increase in GLP-1 levels of up to 250% versus placebo, showing high statistical significance (p=0.014 for 80mg; p=0.003 for 160mg).
The clinical findings were supported by a 6-month preclinical study where IMU-856 reduced body weight gain and food consumption by up to 40% compared to the control group. The company suggests that SIRT6 modulation could potentially offer a broader activation of enteroendocrine hormones compared to current injectable treatments.
IMU-856 is now phase 2 ready and could target the obesity market, which is expected to reach over $170 billion globally by 2031. The drug's potential as an oral alternative to current injectable treatments could represent a significant market opportunity.
Immunic (NASDAQ: IMUX) ha annunciato nuovi dati che mostrano come IMU-856, il loro modulator SIRT6 orale, abbia dimostrato risultati promettenti per potenziali applicazioni nella gestione del peso. Un'analisi post hoc del loro studio di fase 1b sulla celiachia ha rivelato un aumento dose-dipendente dei livelli di GLP-1 fino al 250% rispetto al placebo, mostrando un'alta significatività statistica (p=0.014 per 80mg; p=0.003 per 160mg).
I risultati clinici sono stati supportati da uno studio preclinico di 6 mesi in cui IMU-856 ha ridotto l'aumento di peso corporeo e il consumo di cibo fino al 40% rispetto al gruppo di controllo. L'azienda suggerisce che la modulazione di SIRT6 potrebbe offrire una attivazione più ampia degli ormoni enteroendocrini rispetto ai trattamenti iniettabili attuali.
IMU-856 è ora pronto per la fase 2 e potrebbe mirare al mercato dell'obesità, che si prevede raggiunga oltre 170 miliardi di dollari a livello globale entro il 2031. Il potenziale del farmaco come alternativa orale ai trattamenti iniettabili attuali potrebbe rappresentare un'opportunità di mercato significativa.
Immunic (NASDAQ: IMUX) anunció nuevos datos que muestran que IMU-856, su modulador oral de SIRT6, ha demostrado resultados prometedores para aplicaciones potenciales en el manejo del peso. Un análisis post hoc de su ensayo de fase 1b sobre la enfermedad celíaca reveló un incremento dependiente de la dosis en los niveles de GLP-1 de hasta el 250% en comparación con el placebo, mostrando una alta significancia estadística (p=0.014 para 80mg; p=0.003 para 160mg).
Los hallazgos clínicos fueron respaldados por un estudio preclínico de 6 meses en el que IMU-856 redujo el aumento de peso corporal y el consumo de alimentos en hasta un 40% en comparación con el grupo de control. La empresa sugiere que la modulación de SIRT6 podría ofrecer una activación más amplia de las hormonas enteroendocrinas en comparación con los tratamientos inyectables actuales.
IMU-856 está ahora listo para la fase 2 y podría dirigirse al mercado de la obesidad, que se espera supere los 170 mil millones de dólares a nivel global para 2031. El potencial del fármaco como una alternativa oral a los tratamientos inyectables actuales podría representar una oportunidad de mercado significativa.
Immunic (NASDAQ: IMUX)는 IMU-856, 그들의 경구 SIRT6 조절제가 체중 관리 응용에 대한 유망한 결과를 나타냈다고 발표했습니다. 셀리악병 1b상 시험의 사후 분석에서 GLP-1 수준의 용량 의존적 증가가 위약 대비 최대 250%에 달하며, 높은 통계적 유의성을 보였습니다 (80mg의 경우 p=0.014; 160mg의 경우 p=0.003).
임상 결과는 IMU-856이 대조군에 비해 체중 증가와 음식 소비를 최대 40%까지 줄인 6개월의 전임상 연구로 뒷받침되었습니다. 회사는 SIRT6 조절이 현재의 주사 치료법에 비해 장내 내분비 호르몬의 더 넓은 활성화를 제공할 수 있다고 제안합니다.
IMU-856는 현재 2상 준비 완료 상태이며, 2031년까지 전 세계적으로 1700억 달러를 초과할 것으로 예상되는 비만 시장을 타겟으로 할 수 있습니다. 현재 주사 치료법에 대한 경구 대안으로서의 약물의 잠재력은 상당한 시장 기회를 나타낼 수 있습니다.
Immunic (NASDAQ: IMUX) a annoncé de nouvelles données montrant qu'IMU-856, leur modulateur oral de SIRT6, a démontré des résultats prometteurs pour des applications potentielles de gestion du poids. Une analyse post hoc de leur essai de phase 1b sur la maladie cœliaque a révélé une augmentation dose-dépendante des niveaux de GLP-1 allant jusqu'à 250% par rapport au placebo, montrant une grande signification statistique (p=0.014 pour 80mg; p=0.003 pour 160mg).
Les résultats cliniques ont été soutenus par une étude préclinique de 6 mois où IMU-856 a réduit la prise de poids et la consommation alimentaire jusqu'à 40% par rapport au groupe de contrôle. L'entreprise suggère que la modulation de SIRT6 pourrait potentiellement offrir une activation plus large des hormones enteroendocrines par rapport aux traitements injectables actuels.
IMU-856 est maintenant prêt pour la phase 2 et pourrait cibler le marché de l'obésité, qui devrait atteindre plus de 170 milliards de dollars dans le monde d'ici 2031. Le potentiel du médicament en tant qu'alternative orale aux traitements injectables actuels pourrait représenter une opportunité de marché significative.
Immunic (NASDAQ: IMUX) hat neue Daten veröffentlicht, die zeigen, dass IMU-856, ihr oraler SIRT6-Modulator, vielversprechende Ergebnisse für potenzielle Anwendungen im Gewichtsmanagement gezeigt hat. Eine post hoc Analyse ihrer Phase 1b-Studie zur Zöliakie ergab einen dosisabhängigen Anstieg der GLP-1-Spiegel von bis zu 250% im Vergleich zur Placebogruppe, was eine hohe statistische Signifikanz aufweist (p=0.014 für 80mg; p=0.003 für 160mg).
Die klinischen Ergebnisse wurden durch eine 6-monatige präklinische Studie unterstützt, in der IMU-856 die Gewichtszunahme und den Nahrungsverzehr um bis zu 40% im Vergleich zur Kontrollgruppe reduzierte. Das Unternehmen schlägt vor, dass die SIRT6-Modulation möglicherweise eine breitere Aktivierung der enteroendokrinen Hormone im Vergleich zu den derzeitigen injizierbaren Behandlungen bieten könnte.
IMU-856 ist jetzt bereit für Phase 2 und könnte den Markt für Fettleibigkeit anvisieren, der bis 2031 voraussichtlich weltweit über 170 Milliarden Dollar erreichen wird. Das Potenzial des Medikaments als orale Alternative zu den derzeitigen injizierbaren Behandlungen könnte eine bedeutende Marktchance darstellen.
- Demonstrated significant GLP-1 increase of up to 250% vs placebo in clinical trial
- Showed 40% reduction in food consumption in preclinical studies
- Program is Phase 2 ready for immediate clinical testing
- Targeting obesity market projected to reach $170B by 2031
- Potential oral alternative to current injectable treatments
- Results based on small patient population in phase 1b trial
- Effects still need confirmation in further clinical trials
Insights
The new data for IMU-856 represents a potentially significant breakthrough in metabolic disease treatment through a novel mechanism of action. The compound's ability to modulate SIRT6, leading to both intestinal barrier regeneration and GLP-1 stimulation, suggests a unique dual therapeutic approach that differentiates it from current market solutions.
The clinical data is particularly compelling: the dose-dependent increase in endogenous GLP-1 levels of up to 250% versus placebo was achieved with high statistical significance (p=0.003 for 160mg dose), despite the relatively small sample size. This matches or exceeds the typical 2-3x physiological increase seen post-meal in healthy individuals, suggesting potential therapeutic relevance.
Several key advantages distinguish IMU-856 in the competitive landscape:
- Oral administration versus injectable GLP-1 agonists, potentially offering better patient compliance and accessibility
- Broader physiological activation of enteroendocrine hormones beyond just GLP-1, which could provide more comprehensive metabolic benefits
- Dual mechanism combining barrier regeneration with metabolic effects, potentially addressing multiple aspects of metabolic disorders
The preclinical data showing up to 40% reduction in body weight gain and corresponding decreases in food consumption provides important validation of the clinical observations. The phase 2-ready status positions the company for rapid advancement in clinical development, particularly important given the explosive growth in the obesity treatment market.
However, several critical factors warrant attention:
- The small sample size in the phase 1b trial (N=13 per treatment arm) means larger studies will be needed to confirm these findings
- The long-term safety profile of SIRT6 modulation needs to be established
- The competitive dynamics with established GLP-1 agonists and their strong efficacy data will need to be addressed
– New Data Suggests that IMU-856 Could Be a Potential Oral Treatment Option for Weight Management; Program Is Phase 2 Ready –
– Dose-Dependent Increase of Endogenous GLP-1 Levels Observed in Post Hoc Analysis of Patients From Phase 1b Clinical Trial in Celiac Disease –
– Dose-Dependent Reduction of Body Weight Gain and Food Consumption Observed in Preclinical Study –
– Webcast to be Held Today, February 20 at 8:00 am ET –
"GLP-1, a hormone that occurs naturally in the gut, is released after eating and helps the body regulate blood sugar and satiety. It plays several critical roles, including triggering insulin release from the pancreas and blocking glucagon, a hormone raising blood sugar. Additionally, GLP-1 affects areas of the brain that process hunger and satiety," noted Hella Kohlhof, Ph.D., Chief Scientific Officer of Immunic. "IMU-856's target, SIRT6, is highly expressed in cells of the bowel wall, including enteroendocrine cells, which produce gastrointestinal hormones such as GLP-1 and gastric inhibitory peptide (GIP). Our phase 1b clinical trial in celiac disease patients demonstrated IMU-856's ability to regenerate epithelial cells, as measured by protection of villous height and improved cellular function. The current observations of increased GLP-1 in these celiac disease patients and the preclinical signs of reduced body weight gain indicate that IMU-856 may also have the effect of activating the function of enteroendocrine cells. These findings corroborate the tissue renewal effects already seen for IMU-856 and warrant continued evaluation, as they may meaningfully expand the potential indications for IMU-856."
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.
"This newly released clinical and preclinical data demonstrating IMU-856's potential positive effect on GLP-1 and food consumption is an exciting development for Immunic's oral small molecule program," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "Data from our phase 1b clinical trial in celiac disease patients showed, under fasting conditions, a dose-dependent increase of naturally occurring GLP-1 levels of up to 250 % versus placebo. This compares favorably to the typical physiological 2-3 times increase in GLP-1 in healthy humans after a meal, indicating that IMU-856 may replicate the natural effect after eating. While currently available incretin mimetics delivered via subcutaneous injection are focused on one or two enteroendocrine hormones, we hypothesize that the SIRT6 modulation approach may result in a broader, more physiologic activation of enteroendocrine hormones, which we plan to explore further. If the effects reported today can be confirmed in further clinical trials, our convenient, once-daily small molecule tablet may represent an oral treatment option for obesity – a market with millions of people affected worldwide and which is expected to reach more than
Webcast and Presentation Information
Immunic will host a webcast today at 8:00 am ET. To participate in the webcast, please register in advance at: https://imux.zoom.us/webinar/register/WN_o9yQAoqtT3yWnjb0049_Dw or on the "Events and Presentations" section of Immunic's website at ir.imux.com/events-and-presentations. Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial in access.
An archived replay of the webcast will be available approximately one hour after completion on Immunic's website at ir.imux.com/events-and-presentations.
Today's update, along with phase 1b biomarker data for IMU-856, will also be presented as a digital oral presentation at the 19th Congress of ECCO (European Crohn's and Colitis Organisation). The presentation will be accessible on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations.
- Presentation Title: Promising Effects of IMU-856, an Orally Available Epigenetic Modulator of Barrier Regeneration - Biomarker Findings from a Phase 1 Clinical Study
- Presenting Author: Amelie Schreieck, Ph.D., Senior Manager Biomarker Development, Immunic
- Abstract Number: EC25-1515
- Presentation Number: DOP012
- Presentation Time: 5:57 pm – 6:03 pm CET
- Session Name: Digital Oral Presentation (DOP) Session 2: Clinical Trials II
- Session Date: February 20, 2025
- Session Hall: A8
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. In a post hoc analysis of patients from the phase 1b clinical trial, IMU-856 demonstrated a dose-dependent increase of endogenous glucagon-like peptide-1 (GLP-1) levels and, in preclinical testing, showed a dose-dependent reduction of body weight gain and food consumption, indicating potential as a possible oral treatment option for weight management. The company is currently preparing for further 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 as well as inflammatory bowel disease, Graft-versus-Host-Disease and weight management. 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 or to reduce body weight gain and food consumption; other 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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FAQ
What were the key results of IMU-856's Phase 1b trial for GLP-1 levels?
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