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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
October 9, 2023
IMMUNIC, INC.
(Exact name of registrant as specified in its
charter)
Delaware |
001-36201 |
56-2358443 |
(State or other jurisdiction
of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
1200 Avenue of the Americas, Suite 200
New York, NY 10036
USA
(Address of principal executive offices)
Registrant’s telephone number, including
area code: (332) 255-9818
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of exchange on which registered |
Common Stock, par value $0.0001 |
IMUX |
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§ 240.12b2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act. Yes ☐ No ☐
Item 8.01. Other Events
On October 9, 2023, Immunic, Inc. (the “Company”) issued
a press release and presentation reporting on the
positive interim data from the phase 2 CALLIPER trial of
vidofludimus calcium in progressive multiple sclerosis. The press release and presentation are attached as
Exhibits 99.1 and 99.2 to this Current Report on Form 8-K and are incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the Registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
Dated: October 9, 2023 |
Immunic, Inc. |
|
|
|
|
By: |
/s/ Daniel Vitt |
|
|
Daniel Vitt |
|
|
Chief Executive Officer |
Immunic Reports Positive
Interim Data from Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis
–
24-Week Data from First Half of Patients Shows Improvements in Biomarker NfL, Consistent Throughout the Overall Progressive Multiple Sclerosis
Population as well as All Subtypes –
–
NfL Effect in Non-Active Subpopulation Reinforces Vidofludimus Calcium’s Neuroprotective Potential –
–
Brain Volume Data of the Full 467 CALLIPER Patient Cohort Expected in April 2025 –
–
Phase 3 ENSURE Program in Relapsing Multiple Sclerosis Ongoing –
–
Conference Call and Webcast to be Held Tomorrow, October 10, 2023 at 8:00 am ET –
NEW YORK,
October 9, 2023 – 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 positive interim data from its phase 2 CALLIPER trial of nuclear receptor related 1 (Nurr1)
activator, vidofludimus calcium (IMU-838), in patients with progressive multiple sclerosis (PMS). The Company believes that this data
shows biomarker evidence that vidofludimus calcium’s activity extends beyond the previously observed anti-inflammatory effects,
thereby further reinforcing its neuroprotective potential.
The predefined interim analysis examined the change
from baseline to 24 weeks in serum neurofilament light chain (NfL) and glial fibrillar acidic protein (GFAP) levels among approximately
the first half of patients enrolled in this trial. Serum NfL results are as follows:
|
|
Total N |
45 mg vidofludimus calcium versus placebo |
Change in serum NfL at 24 weeks in % of baseline as compared to placebo |
All PMS |
N=203 |
-22.4% |
PPMS* |
N=59 |
-18.8% |
Non-Active SPMS |
N=124 |
-20.1% |
Active SPMS |
N=20 |
-43.3% |
PPMS: primary progressive multiple sclerosis;
SPMS: secondary progressive multiple sclerosis
* The only approved
drug for PPMS, Ocrevus® (ocrelizumab), showed a 12.4% reduction versus placebo in 24-week serum NfL levels in the phase 3 ORATORIO
trial (Bar-Or A. et al., EBioMedicine. 2023 Jul;93:104662).
Serum NfL responses were consistently observed
for vidofludimus calcium across progressive MS disease and all subpopulations. In the overall PMS population at 24 weeks (N=203), vidofludimus
calcium was associated with a 6.7% reduction from baseline in serum NfL, compared to a
15.8% increase over baseline in placebo (p=0.01, post hoc). At 48 weeks (N=79), vidofludimus calcium reduced
serum NfL by 10.4% from baseline, compared to a 6.4%
increase in placebo. Substantial reductions were also seen across all PMS subtypes,
as well as in patients that show or do not show disease and/or magnetic resonance imaging (MRI) activity.
Although early, interim
GFAP data also showed a promising signal: at 24 weeks (N=203), GFAP increased by 3.7% for vidofludimus calcium, and 4.4% for placebo.
At 48 weeks (N=79), the change was only 2.7% for vidofludimus calcium, with a 6.4% increase for placebo. Progression of GFAP response
is generally thought to evolve more slowly than NfL, and the Company believes that a longer follow-up may further strengthen this signal.
“Serum NfL has been consistently shown to
capture disease activity and to predict future disability in MS. Vidofludimus calcium shows a separation in serum NfL over placebo in
this interim analysis, an effect also seen across different subgroups,” stated Prof. Jens Kuhle, M.D., Ph.D., Senior Physician,
Head of Neuroimmunology Unit and Multiple Sclerosis Centre, University Hospital Basel, Switzerland. “Particularly remarkable, the
non-active progressive MS population, which represents the highest unmet medical need in MS, also showed differences in NfL levels over
this relatively short observation period in favor of vidofludimus calcium. Meanwhile, although longer follow-up is needed, the GFAP data
set also shows a potential promising early signal. Overall, the interim biomarker data further support vidofludimus calcium’s possible
activity beyond an anti-inflammatory effect, which may be related to its potent Nurr1 activation.”
“The
clear separation observed in serum NfL for vidofludimus calcium over placebo in the PMS patient
population represents another major step forward for, what potentially could be, a first-in-class
Nurr1 activator for MS,” commented Daniel Vitt, Ph.D., Chief Executive Officer and
President of Immunic. “Although no head-to-head data is available, it is encouraging to see that vidofludimus calcium's improvement
in NfL over placebo appears at least as good as, and is in fact numerically higher than that observed with historical studies of other
therapeutic approaches for PMS. We believe that, if the top-line CALLIPER data, expected
in April of 2025, continue to show a neuroprotective effect, we may be able to position vidofludimus calcium as the first oral treatment
option for non-active SPMS. Additionally, the drug’s first-in-class ability to activate
Nurr1, a known neuroprotective target, should also significantly benefit our ongoing phase 3 ENSURE
program in relapsing MS where prevention of disability progression independent of relapse
activity (PIRA), serves as a key outcome.”
“We
are very pleased to see such strong improvements in serum NfL for vidofludimus calcium over placebo in the overall PMS population
of this interim analysis, as well as across all PMS subtypes and in patients with and without disease
activity, and with and without MRI activity. We even saw evidence in
non-active SPMS, a population where the medical need for new therapies is high as there is currently no relevant treatment available in
the US,” added Andreas Muehler, M.D., Chief Medical Officer of Immunic. “Finally, we were also excited to see an encouraging
early signal with GFAP. This is a newer biomarker which is thought to evolve more slowly and with lower amplitude than NfL, and longer
follow-up will hopefully allow us to see even
stronger results.”
The Company believes that these results corroborate
separate findings from its phase 2 EMPhASIS trial in relapsing-remitting multiple sclerosis (RRMS), where vidofludimus calcium was associated
with a decrease in serum NfL at 24 weeks (-17.0% for 30 mg and -20.5% for 45 mg) as compared to baseline values, as contrasted with a
6.5% increase in serum NfL over baseline among placebo patients.
CALLIPER
is a multicenter, randomized, double-blind, placebo-controlled phase 2 trial which enrolled 467 patients with primary PMS or active or
non-active secondary PMS at more than 70 sites throughout North America as well as Western, Central and Eastern Europe. Patients were
randomized to either 45 mg daily doses of vidofludimus calcium or placebo, and the trial’s primary endpoint is the annualized rate
of percent brain volume change up to 120 weeks. Key secondary endpoints include the annualized rate of change in whole brain atrophy and
time to 24-week confirmed disability progression based on the expanded disability status scale (EDSS).
Anticipated
MS Clinical Milestones
| · | Top-line da
ta from the phase 2 CALLIPER trial of vidofludimus calcium in PMS is expected in April of 2025. |
| · | Data from the interim analysis of the phase 3 ENSURE program of
vidofludimus calcium in relapsing MS is expected in late 2024, with the top-line readout of the first of the ENSURE trials at the end
of 2025. |
For more information on the phase 2 CALLIPER trial,
please visit: www.clinicaltrials.gov, NCT05054140.
The interim data of the phase 2 CALLIPER trial
of vidofludimus calcium in PMS will be filed on a Form 8-K and discussed during the management presentation to be held tomorrow at 8:00
am ET. The presentation will also be accessible on the “Events and Presentations” section of Immunic’s website at: https://ir.imux.com/events-and-presentations.
Webcast Information
Immunic will host a webcast tomorrow, October
10, 2023, at 8:00 am ET to discuss these results. To participate in the webcast, please register in advance at: https://imux.zoom.us/webinar/register/WN_evpnpdOKQX2AKEXpCacoUA
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.
About Progressive Multiple Sclerosis
Multiple
sclerosis (MS) is an autoimmune disease that affects the brain, spinal cord and optic nerve. In MS, myelin, the coating that protects
the nerves, is attacked and damaged by the immune system. Thus, MS is considered an immune-mediated demyelinating disease of the central
nervous system. Progressive multiple sclerosis (PMS) includes both primary progressive MS (PPMS) and secondary progressive MS (SPMS).
PPMS is characterized by steadily worsening neurologic function from the onset of symptoms without initial relapse or remissions. SPMS
is identified following an initial relapsing-remitting course, after which the disease becomes
more steadily progressive, with (active SPMS) or without (non-active SPMS) other
disease activity present.
About Vidofludimus
Calcium (IMU-838)
Vidofludimus
calcium is a small molecule investigational drug in development as an oral next-generation treatment option for patients with multiple
sclerosis and other chronic inflammatory and autoimmune diseases. The selective immune modulator activates the neuroprotective
transcription factor nuclear receptor related 1 (Nurr1), which is associated with direct neuroprotective properties. Additionally,
vidofludimus calcium is a known inhibitor of the enzyme dihydroorotate dehydrogenase (DHODH), which is a key enzyme in the metabolism
of overactive immune cells and virus-infected cells. This mechanism is associated with the anti-inflammatory and anti-viral effects of
vidofludimus calcium. Vidofludimus calcium has been observed to selectively act on hyperactive T and B cells while leaving other immune
cells largely unaffected and enabling normal immune system function, e.g., in fighting infections. To date, vidofludimus calcium has been
tested in more than 1,400 individuals and has shown an attractive pharmacokinetic, safety and tolerability profile. Vidofludimus calcium
is not yet licensed or approved in any country.
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 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, where 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, 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 vidofludimus calcium to safely and effectively target diseases; preclinical and clinical data for vidofludimus calcium;
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 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
KOGS Communication
Edna Kaplan
+1 617 974 8659
kaplan@kogspr.com
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Grafico Azioni Immunic (NASDAQ:IMUX)
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