Full Press Release Details
Immunic Announces Positive Results
from Single and Multiple Ascending Dose Parts of Its Phase 1 Clinical Trial of IMU-856 in Healthy Human Subjects
Unblinded Data Revealed a Favorable Safety, Tolerability and Pharmacokinetic Profile
for IMU-856 in Single and 14-Day Multiple Dosing -
- No Maximum Tolerated Dose
Reached; Investigated Doses Expected to Exceed Required Therapeutic Dosing of IMU-856 -
Portion of Phase 1 Clinical Trial in Patients with Celiac Disease Ongoing -
Webcast to be Held Today, September 20, 2022, at 8:30 am ET -
September 20, 2022 - Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a
pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, today 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. IMU-856 is an orally available and systemically acting
small molecule modulator that targets a protein which serves as a transcriptional regulator of intestinal barrier function and regeneration
of bowel epithelium.
In the SAD part of the phase 1 clinical trial,
healthy human subjects were randomized in a double-blinded manner to either placebo or active treatment with single ascending doses of
IMU-856 at 10 mg, 20 mg, 40 mg, 80 mg, 120 mg and 160 mg. 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. These favorable results allowed a smooth transition to the MAD part of the trial.
In the MAD part of this phase 1 clinical trial,
healthy human subjects were dosed for 14 consecutive days with 40 mg, 80 mg or 160 mg once-daily of IMU-856 or placebo in a double-blinded
manner. Multiple ascending doses of IMU-856 were found to be safe and well-tolerated and no maximum tolerated dose was reached. Treatment
emergent adverse events (TEAEs) were mostly mild in severity. No Investigational Medicinal Product (IMP)-related serious adverse events
were reported. No dose-dependent changes in laboratory parameters (including no effects on liver enzymes or in hematological parameters),
vital signs, physical examination or electrocardiographic evaluations were found. PK analysis showed a quick achievement of stable steady-state
plasma concentrations within the first week and stable steady-state trough levels over the 14-day treatment period with a low accumulation
factor for IMU-856, allowing predictable trough levels during daily dosing. PK parameters in steady-state revealed a Tmax (time
to reach maximum plasma concentration) of 2 to 3 hours post-dose, a plasma half-life of 17.4 to 21.5 hours and dose proportional increases
in Cmax (maximum plasma drug concentration) and AUC (area under the concentration-time curve).
"The unblinded data from the single and
multiple ascending dose parts of our phase 1 clinical trial of IMU-856 in healthy human subjects revealed a favorable safety, tolerability
and pharmacokinetic profile. In line with our preclinical findings, the data did not show any drug-related adverse events or laboratory
abnormalities that would require further investigation. In addition, the pharmacokinetic results indicate that IMU-856 is well suited
for a once-daily oral administration," stated Andreas Muehler, M.D., Chief Medical Officer of Immunic. "As expected, our phase
1 clinical trial of IMU-856 was expanded in May 2022 to include a third portion, comprised of well controlled celiac disease patients
receiving IMU-856 daily over 28 consecutive days. This portion of the trial is still ongoing. We believe that celiac disease is not only
an ideal proof-of-concept indication to investigate IMU-856's acute and chronic impact, as the disease represents a significant
unmet need with well characterized surrogate markers of disease activity, but is also an attractive medical target with very few treatment
The ongoing Part C of the phase 1 program includes
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 gluten challenge. A total of approximately 42 patients are planned to be enrolled in two
consecutive cohorts with 80 mg or 160 mg of IMU-856 given once-daily over 28 days. Secondary objectives include pharmacokinetics as well
as acute and chronic disease markers, including those evaluating gastrointestinal architecture and inflammation. Sites in Australia and
New Zealand are participating in Part C.
"We are very excited about the excellent
safety, tolerability and pharmacokinetic results of IMU-856, our small molecule modulator targeting restoration of intestinal barrier
function and regeneration of bowel epithelium, in healthy human subjects," added Daniel Vitt, Ph.D., Chief Executive Officer and
President of Immunic. "These phase 1 results support our ultimate vision of establishing IMU-856 as a potential first-in-class oral
celiac disease therapy. Additionally, IMU-856's mechanism could present an entirely new approach to treat a significant number of
serious and widely prevalent gastrointestinal diseases, and we believe it could potentially offer a clinical benefit without the serious
consequences associated with many immunosuppressive therapies."
Immunic's management team will host a webcast
today, September 20, 2022, at 8:30 am Eastern Time to discuss the clinical phase 1 SAD/MAD data from the company's IMU-856 program.
To participate in the webcast, please register
in advance at: https://imux.zoom.us/webinar/register/WN_OMiybBQ0ThmKDGIFW2WCuA 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.
IMU-856, which Immunic believes to be novel, is
an orally available and systemically acting small molecule modulator that targets 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 new 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 maintain immune surveillance for patients during therapy, an important advantage
versus chronic treatment with potentially immunosuppressive medications. IMU-856 is an investigational drug product that has not been
approved in any jurisdiction.
IMU-856 was discovered by Daiichi Sankyo Co.,
Ltd. (Daiichi Sankyo). In November 2018, Immunic and Daiichi Sankyo entered into a global option and license agreement, granting Immunic
the exclusive right to license IMU-856. Immunic exercised the option in January 2020.
Immunic, Inc. (Nasdaq: IMUX) is a clinical-stage
biopharmaceutical company with a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune
diseases. The company is developing three small molecule products: its lead development program, vidofludimus calcium (IMU-838), a selective
immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme DHODH and exhibits a host-based
antiviral effect, is currently being developed as a treatment option for multiple sclerosis, and primary sclerosing cholangitis. IMU-935,
a selective inverse agonist of the transcription factor ROR /ROR t, is targeted for development in psoriasis, and castration-resistant
prostate cancer. IMU-856, which targets the restoration of the intestinal barrier function, is targeted for development in diseases involving
bowel barrier dysfunction. For further information, please visit: www.imux.com.
Statement Regarding Forward-Looking Statements
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 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 three development programs and the
targeted diseases; the potential for IMU-856 to safely and effectively target diseases; interpretation of preclinical and clinical data
for IMU-856 and potential effects; 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, impacts of the Ukraine - Russia conflict on 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,