Immunic Inc (NASDAQ:IMUX) has reflected on key milestones achieved in 2024, including advancing its novel therapy, vidofludimus calcium, toward key data readouts and securing significant funding to progress its clinical programs.
In a statement, the company said it expects top-line data from the Phase 2 CALLIPER trial of vidofludimus calcium in progressive multiple sclerosis (PMS) in April 2025.
“We eagerly anticipate reporting top-line data from the CALLIPER trial in April,” Immunic CEO Daniel Vitt said.
“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."
Interim analysis of the ongoing Phase 3 ENSURE trials for relapsing multiple sclerosis (RMS) has returned positive results, with an independent data monitoring committee confirming the trials are not futile and recommending their continuation without adjustments. The completion of these trials is anticipated in 2026.
“These favorable recommendations corroborated our initial assumptions about the design, powering and relapse rate of the trials and illustrate that they remain on track,” Vitt said.
Throughout 2024, Immunic presented critical data on vidofludimus calcium at major conferences, showcasing its neuroprotective and anti-inflammatory properties.
Key findings included interim data from the CALLIPER trial, antiviral effects linked to fatigue reduction, and additional evidence supporting its therapeutic potential.
The company also initiated enrollment for the Phase 2 RAPID_REVIVE trial investigating vidofludimus calcium for post-COVID syndrome.
Additionally, progress was made with the IMU-856 program, as positive data from its Phase 1/1b trial was published in The Lancet Gastroenterology & Hepatology.
Preparations for Phase 2 testing of IMU-856 are underway, pending financing or partnerships.
“We continue to believe that IMU-856 could offer a new therapeutic approach for various gastrointestinal disorders, also beyond celiac disease,” Vitt highlighted.
On the corporate front, Immunic strengthened its leadership team with several key appointments, including naming Jason Tardio as its new president and chief operating officer.
"Since joining Immunic in July 2024, we have ramped up our efforts preparing for the potential commercial launch of vidofludimus calcium,” Tardio said.
“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."
The company also secured $80 million in gross proceeds from the initial tranche of a $240 million private placement, extending its cash runway into the third quarter of 2025.
Further, Immunic expanded its intellectual property portfolio with a new US patent for vidofludimus calcium, providing protection until 2041.
Shares of Immunic added 1.8% in Tuesday morning trading.
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