Immunic Highlights 2024 Accomplishments and Upcoming Milestones
PR Newswire
NEW YORK, Jan. 7, 2025
-- Top-Line Data from Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis Expected in April --
-- Reported Positive Outcome from Interim Analysis of Ongoing, Twin Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis; Both Trials on Track to Be Completed in 2026 --
-- Strengthened Management Team and Board of Directors with Key Hires --
-- Announced a Three-Tranche Private Placement Totaling Up to $240 Million, Extending Cash Runway Into the Third Quarter of 2025, Based on Initial $80 Million Tranche --
NEW YORK, Jan. 7, 2025 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today highlighted its 2024 accomplishments and upcoming milestones.
"The past year was marked by substantial progress for our orally available lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), as we continued to advance both our phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS) and our twin phase 3 ENSURE trials in relapsing multiple sclerosis $(RMS.AU)$," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "Looking ahead, we eagerly anticipate reporting top-line data from the CALLIPER trial in April. The previously reported interim results showed a clear reduction versus placebo in neurofilament light chain (NfL) levels across the PMS patient population, hinting to potential neuroprotective effects of the drug."
"We also achieved a significant milestone for our phase 3 ENSURE program, having received a positive interim result from an unblinded Independent Data Monitoring Committee (IDMC), which concluded that the trials are not futile and recommended they should continue as planned, without any sample size increase. These favorable recommendations corroborated our initial assumptions about the design, powering and relapse rate of the trials and illustrate that they remain on track. The result makes us immensely confident and excited as we await the completion of the twin phase 3 trials: ENSURE-1 remains on track for completion in the second quarter of 2026, with ENSURE-2 expected to follow in the second half of 2026."
Jason Tardio, President and Chief Operating Officer of Immunic, added, "Since joining Immunic in July 2024, we have ramped up our efforts preparing for the potential commercial launch of vidofludimus calcium. There continues to be a large unmet medical need for new therapeutic advancements in the treatment of MS that address both the neuroinflammatory and neurodegenerative aspects of the disease to better slow disability worsening. Vidofludimus calcium is the only medicine in development that targets activation of Nurr1 for neuroprotection and combines that with selective inhibition of DHODH for anti-inflammatory and antiviral effects. We believe our drug has the potential to become the first oral disease-modifying therapy approved to treat both relapsing and progressive MS to address the full spectrum of the disease."
Dr. Vitt concluded, "In 2024, we were also honored to have had our previously reported results from the phase 1/1b clinical trial of IMU-856, our orally available and systemically acting small molecule modulator targeting Sirtuin 6 (SIRT6), a protein which serves as a transcriptional regulator of intestinal barrier function and physiological regeneration of bowel epithelium, published in the peer reviewed journal, The Lancet Gastroenterology & Hepatology. Data from this study showed that, in patients with celiac disease during periods of gluten-free diet and gluten challenge, IMU-856 demonstrated positive effects over placebo in four key dimensions of celiac disease, including protection of the gut architecture, improvement of patients' symptoms, biomarker response, and enhancement of nutrient absorption. We continue to believe that IMU-856 could offer a new therapeutic approach for various gastrointestinal disorders, also beyond celiac disease."
2024 Corporate Highlights
-- Strengthened the Board of Directors in July, with the appointment
of Simona Skerjanec, M.Pharm, MBA, a thought-leader in brain health with
decades of experience.
-- In July, appointed seasoned biopharmaceutical executive, Jason Tardio, as
President and Chief Operating Officer, to lead internal efforts in
positioning the company for the potential launch of vidofludimus calcium
and to work closely with Patrick Walsh, Chief Business Officer, to
prepare the company for a range of potential partnership outcomes.
Additionally, reported that Werner Gladdines, former Vice President,
Program Management & Clinical Development Operations, was promoted to
Chief Development Officer.
-- Announced a three-tranche private placement totaling up to $240 million,
with participation from select new and existing investors, in January.
The initial tranche successfully closed on January 8, 2024, with Immunic
securing $80 million in gross proceeds.
Vidofludimus Calcium 2024 Highlights and Upcoming Milestones
-- Completion of the ENSURE-1 trial of vidofludimus calcium in RMS is
anticipated in the second quarter of 2026, with completion of ENSURE-2
expected in the second half of 2026.
-- Top-line data for the phase 2 CALLIPER trial of vidofludimus calcium in
PMS is expected in April of this year.
-- Announced a positive outcome of the interim analysis of the phase 3
ENSURE program, investigating vidofludimus calcium for the treatment of
RMS, in October. An unblinded IDMC confirmed that the trials are not
futile and recommended they should continue without changes, including no
need for a potential increase of the sample size.
-- Presented key data on vidofludimus calcium in four presentations at the
40th Congress of the European Committee for Treatment and Research in
Multiple Sclerosis (ECTRIMS) in September. The data included the NfL
interim data from the phase 2 CALLIPER trial, antiviral data suggesting
an effect on reducing fatigue, Nurr1 target data supporting a
neuroprotective profile, and pathogenic T cell data further supporting
the drug's anti-inflammatory effects.
-- Announced enrollment of the first patient in the investigator-sponsored
phase 2 RAPID_REVIVE trial of vidofludimus calcium in patients with post
COVID syndrome in September.
-- Hosted an MS R&D Day in New York City in September, focused on
vidofludimus calcium's potential to become the treatment of choice for
both RMS and PMS patients. Presenting MS industry experts
included Francesca Montarolo, Ph.D., Neuroscience Institute Cavalieri
Ottolenghi (NICO) and University of Turin, Italy and Amit Bar-Or, M.D.,
FRCPC, Department of Neurology, Perelman School of Medicine, University
of Pennsylvania.
-- Published extended data from the phase 2 EMPhASIS trial of vidofludimus
calcium in relapsing-remitting MS in the peer reviewed journal,
Neurology$(R)$ Neuroimmunology & Neuroinflammation, an official journal of
the American Academy of Neurology, in April.
-- Hosted an MS R&D Day in San Francisco in April, during which management
discussed the latest developments in the MS landscape, along with recent
preclinical and clinical data supporting the neuroprotective potential of
vidofludimus calcium.
-- Received a Notice of Allowance from the United States Patent and
Trademark Office (USPTO) in March, for a patent covering the
composition-of-matter of a specific polymorph of vidofludimus calcium and
a related method of production of the material. The company's
multilayered intellectual property strategy now provides protection into
2041 in the United States, unless extended further.
-- Presented data from the company's phase 2 CALLIPER and CALVID-1 trials of
vidofludimus calcium, in two poster presentations at the Americas
Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS)
Forum 2024 in February.
IMU-856 2024 Highlights and Upcoming Milestones
-- Announced the publication of data from the phase 1/1b clinical trial of
IMU-856 in the peer reviewed journal, The Lancet Gastroenterology &
Hepatology in November.
-- Based on the positive data from the phase 1b clinical trial, the company
continues preparing for clinical phase 2 testing of IMU-856, contingent
on financing, licensing or partnering.
Immunic's management, business development and investor relations teams will be hosting one-on-one meetings in connection with the 43rd Annual J.P. Morgan Healthcare Conference taking place January 13-16, 2025, in San Francisco. To schedule a meeting, please contact: Jessica Breu at jessica.breu@imux.com.
About Immunic, Inc.
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