Tillkännagivande • Feb 19

Immunic, Inc. Announces Positive Top-Line Data From Investigator-Sponsored Phase 2 Proof-of-Concept Clinical Trial of IMU-838 in Primary Sclerosing Cholangitis

Immunic, Inc. announced positive top-line data from an investigator-sponsored phase 2 proof-of-concept clinical trial of IMU-838 in primary sclerosing cholangitis (PSC). This single-arm, open-label, exploratory study was designed to investigate IMU-838's potential to improve various biochemical parameters in PSC patients and help determine whether any such activity warrants further investigation in randomized PSC trials. As previously announced, due to the COVID-19 pandemic, only 18 of the targeted 30 patients were enrolled in the study (intent-to-treat population, ITT), of whom only 11 patients completed the full IMU-838 treatment course and were evaluable over the 24-week treatment period (per-protocol population, PP). The PP population experienced a statistically significant decrease in serum alkaline phosphatase (ALP) levels (p=0.041) after 24 weeks of treatment using 30 mg IMU-838 once daily, as compared to baseline. A consistent individual pattern of a stable decrease in ALP values was observed in the PP population between baseline and week 24, without any single patient showing an increase of more than 20% of ALP. As per the definition of the primary objective of the study, 27.3% of the patients in the PP population had a clinically relevant reduction of serum ALP higher than 25% at week 24, without an increase in liver biochemistry of more than 33%, as compared to baseline. Biochemical endpoints, such as changes in serum ALP, have been used in PSC trials performed by third parties. Regarding the secondary objectives of the study, no changes in aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total, direct or indirect bilirubin were observed in the ITT or PP populations, as compared to baseline. In addition, despite the limited scope of the data, encouraging results were observed regarding symptoms of inflammatory bowel disease, a common comorbidity for PSC patients, and patient assessments of health-related quality of life. The study also found that IMU-838 is a safe and well-tolerated oral drug for PSC patients and treatment-emergent adverse events were rare and generally mild. Study Background and Baseline Characteristics: The single-arm, open label, exploratory study was an investigator-sponsored trial led by Elizabeth Carey, M.D., Professor of Medicine, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Mayo Clinic, who had received Investigator Investigational New Drug (IND) approval from the U.S. Food & Drug Administration (FDA) and had been granted Institutional Review Board (IRB) approval to conduct the study. The study was supported by a grant from the National Institutes of Health (NIH) and was conducted at two sites: Mayo Clinic, Phoenix, Arizona (Dr. Carey) and Mayo Clinic, Rochester, Minnesota (John E. Eaton, M.D.), both of which are tertiary referral centers for PSC patients. The study, for which Immunic provided the study medication, planned to enroll 30 patients with PSC, aged 18 to 75 years, who received 30 mg of IMU-838 once daily for a period of 24 weeks. Enrollment for the study took place between July 2019 and September 2020, but almost all enrollment occurred in 2019 and early 2020. During the COVID-19 pandemic, recruitment for this study was hampered, as patients with PSC are at a high risk of COVID-19 infections and were advised to avoid travel and unnecessary social contacts such as those required to participate in a clinical trial. Together with the investigators, Immunic determined to readout data of the 18 patients who were enrolled prior to the COVID-19 pandemic. The ongoing COVID-19 pandemic also triggered the principal investigator's decision to terminate the study in late 2020, before the intended recruitment goal of 30 patients was reached. A total of 18 patients started treatment of 30 mg IMU-838 once daily (intent-to-treat population, ITT, n=18). Of these 18 patients, 11 patients received the full 24-week treatment with IMU-838 (per-protocol population, PP, n=11). Due to the high number of discontinued patients during the COVID-19 pandemic and the fact that all discontinued patients in an ITT statistical analysis will be counted as treatment failures at week 24, this analysis focuses mainly on the 11-patient PP population. Primary Objective: The primary objective of this study was to determine whether IMU-838 reduces serum ALP in adult patients diagnosed with PSC. The main analysis for the primary objective was whether patients could achieve a reduction of ALP at week 24 which is greater or equal to 25%, as compared to baseline, while the AST increase at week 24 is no more than 33%, as compared to baseline. This positive primary outcome was achieved by 3 of 11 patients in the PP population (27.3%, 95% CI: 6-61%). By virtue of inclusion criteria, patients at baseline had to have an elevated ALP value of at least 1.5 times upper limit of normal (ULN). In addition, time from baseline was calculated as a continuous variable and treated as the primary predictor using a random intercept model which was adjusted for age at baseline and gender. For this longitudinal analysis of ALP from baseline to week 24 in the PP population, the ALP value statistically significantly (p=0.041) decreased by an average of 5.76 IU/L every 30 days (95% CI: -11.29, -0.23; statistical model). The time trend was not statistically significant in the ITT analysis (p=0.578) due to missing data following the high rate of treatment discontinuations during the COVID-19 pandemic. Secondary Objectives: Secondary objectives were to investigate the liver biochemistry parameters, AST, ALT, and total/direct/indirect bilirubin, as well as the concentrations of proinflammatory cytokines, as compared to baseline. The longitudinal analysis of both AST and ALT as well as total, direct and indirect bilirubin values showed a stable pattern in the PP population with no statistically significant change over time and the confidence interval to include the no-change scenario (AST: average 30 day change 1.22 IU/L, 95% CI: -0.53, 2.97, p=0.170; ALT: average 30 day change 0.85 IU/L, 95% CI -1.46, 3.15, p=0.467, total bilirubin: average 30 day change 0.00 mg/dL, 95% CI -0.01, 0.02, p=0.561, direct bilirubin: average 30 day change 0.00 mg/dL, 95% CI -0.01, 0.01, p=0.861, indirect bilirubin: average 30 day change 0.00 mg/dL, 95% CI -0.01, 0.01, p=0.556). Similar results were found in the ITT population. In addition, a decrease in the Ulcerative Colitis Clinical score was observed in evaluated patients, although the number of assessed patients was limited.

VD-lön i procent	n/a
Anställning som VD	less than a year
Ägande av VD	n/a
Ledningens genomsnittliga anställningstid	3.4yrs
Styrelsens genomsnittliga mandatperiod	5.7yrs

Namn	Position	Anställning	Kompensation	Ägarskap
Jason Tardio	COO & President	2yrs	US$1.20m	0.0092% € 16.3k
Daniel Vitt	Founder & Director	no data	US$2.30m	0.29% € 510.1k
Glenn Whaley	Chief Financial Officer	6.3yrs	US$1.06m	0.070% € 124.3k
Erik Lundgren	Chief Executive Officer	less than a year	inga uppgifter	inga uppgifter
Hella Kohlhof	Chief Scientific Officer	9.5yrs	inga uppgifter	inga uppgifter
Jessica Breu	Vice President of Investor Relations & Communications	no data	inga uppgifter	inga uppgifter
Inderpal Singh	General Counsel	5.1yrs	inga uppgifter	inga uppgifter
Patrick Walsh	Chief Business Officer	4.8yrs	inga uppgifter	inga uppgifter
Werner Gladdines	Chief Development Officer	2yrs	inga uppgifter	inga uppgifter
Michael A. Panzara	Chief Medical Officer	less than a year	inga uppgifter	inga uppgifter

Namn	Position	Anställning	Kompensation	Ägarskap
Daniel Vitt	Founder & Director	7.3yrs	US$2.30m	0.29% € 510.1k
Barclay Phillips	Lead Independent Director	6.7yrs	US$171.98k	0.21% € 365.7k
Michael Bonney	Chair of the Board	less than a year	inga uppgifter	inga uppgifter
Tamar Howson	Independent Director	6.8yrs	US$149.82k	0.21% € 365.7k
Jorg Neermann	Independent Director	7.3yrs	US$156.98k	0.15% € 260.4k
Paul Utz	Member of Scientific Medical Advisory Board	5.7yrs	inga uppgifter	inga uppgifter
Duane Nash	Director	7.5yrs	US$979.88k	0.026% € 46.9k
Bruce Sands	Member of Scientific Medical Advisory Board	5.7yrs	inga uppgifter	inga uppgifter
Fred Lublin	Member of Scientific Medical Advisory Board	5.7yrs	inga uppgifter	inga uppgifter
Richard Rudick	Independent Director	3.3yrs	US$149.48k	0.17% € 299.9k
Jon Congleton	Independent Director	less than a year	inga uppgifter	inga uppgifter
Simona Skerjanec	Independent Director	2yrs	US$149.14k	0.15% € 260.4k

Uppgifter	Senast uppdaterad (UTC-tid)
Analys av företag	2026/07/07 23:41
Aktiekurs vid dagens slut	2026/07/07 00:00
Intäkter	2026/03/31
Årlig intjäning	2025/12/31

Paket	Uppgifter	Tidsram	Exempel US-källa
Företagets finansiella ställning	10 år	Resultaträkning Kassaflödesanalys Balansräkning	SEC Form 10-K SEC Form 10-Q
Analytikernas konsensusuppskattningar	+3 år	Prognos för finansiella poster Analytikernas prismål	Rapporter från analytiker Blue Matrix
Marknadspriser	30 år	Aktiekurser Utdelningar, splittar och åtgärder	ICE Marknadsdata SEC Form S-1
Ägarskap	10 år	Största aktieägare Insiderhandel	SEC Formulär 4 SEC Formulär 13D
Förvaltning	10 år	Ledningsgrupp Styrelse och verkställande direktörer	SEC Form 10-K SEC Form DEF 14A
Viktiga utvecklingstendenser	10 år	Företagsmeddelanden	SEC Formulär 8-K

Analytiker	Institution
George Farmer	BMO Capital Markets Equity Research
William Wood	B. Riley Securities, Inc.
Tyler Bussian	Brookline Capital Markets

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