Immunic Highlights 2024 Accomplishments and Upcoming Milestones

Key Takeaways:

• Top-line data from Phase 2 CALLIPER trial in Progressive MS expected in April
• Positive interim results from Phase 3 ENSURE trials in Relapsing MS; trials on track for 2026 completion
• Strengthened management team with key hires, including President and COO Jason Tardio
• Secured up to $240 million in private placement financing, extending cash runway into Q3 2025
• Published positive Phase 1/1b trial results for IMU-856 in celiac disease patients

Immunic’s Breakthroughs in Multiple Sclerosis Treatment

Promising Trial Results for Vidofludimus Calcium

Immunic, Inc., a biotechnology company specializing in therapies for chronic inflammatory and autoimmune diseases, has highlighted significant accomplishments from 2024 and outlined upcoming milestones for 2025. Central to these advancements is their lead drug candidate, vidofludimus calcium (IMU-838), an orally administered small molecule therapy currently in clinical trials for multiple sclerosis (MS).

“The past year was marked by substantial progress for our orally available lead asset, vidofludimus calcium,” stated Dr. Daniel Vitt, Chief Executive Officer of Immunic. “We eagerly anticipate reporting top-line data from the Phase 2 CALLIPER trial in patients with progressive multiple sclerosis in April. The previously reported interim results showed a clear reduction versus placebo in neurofilament light chain (NfL) levels across the patient population, hinting at potential neuroprotective effects of the drug.”

The CALLIPER trial focuses on patients with progressive MS (PMS), a form of the disease with limited treatment options. The upcoming data release is highly anticipated within the medical community.

Phase 3 ENSURE Trials On Track

In addition to advancements in PMS, Immunic reported a positive outcome from the interim analysis of the twin Phase 3 ENSURE trials, which investigate vidofludimus calcium for relapsing multiple sclerosis (RMS). An unblinded Independent Data Monitoring Committee (IDMC) concluded that the trials are not futile and recommended they continue without changes.

“These favorable recommendations corroborated our initial assumptions about the design, powering, and relapse rate of the trials,” Dr. Vitt noted. “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.”

Strengthening Leadership for Future Growth

To support these developments, Immunic has strengthened its management team. In July, seasoned biopharmaceutical executive Jason Tardio joined as President and Chief Operating Officer.

“Since joining Immunic, we have ramped up our efforts preparing for the potential commercial launch of vidofludimus calcium,” Tardio said. “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.”

Additionally, the company appointed Simona Skerjanec, M.Pharm, MBA, a thought-leader in brain health, to its Board of Directors, bringing decades of experience to the team.

Securing Financial Stability

In January, Immunic announced a three-tranche private placement totaling up to $240 million, extending its cash runway into the third quarter of 2025. The initial tranche closed successfully on January 8, 2024, securing $80 million in gross proceeds.

Advancements Beyond Multiple Sclerosis

Immunic’s pipeline extends beyond MS. The company announced the publication of data from the Phase 1/1b clinical trial of IMU-856 in The Lancet Gastroenterology & Hepatology . IMU-856 targets Sirtuin 6 (SIRT6) and is intended to restore intestinal barrier function.

“Data from this study showed that, in patients with celiac disease, IMU-856 demonstrated positive effects over placebo in four key dimensions, including protection of the gut architecture and improvement of patients’ symptoms,” Dr. Vitt stated. “We continue to believe that IMU-856 could offer a new therapeutic approach for various gastrointestinal disorders.”

Looking Ahead

With significant milestones on the horizon, Immunic is poised for a pivotal year. The anticipated data from the CALLIPER trial could mark a breakthrough in treating progressive MS, while the ongoing ENSURE trials may solidify vidofludimus calcium’s role in relapsing MS.

As the company prepares for potential commercialization, its strengthened leadership and secured funding position Immunic to advance its mission of developing innovative therapies for patients with chronic diseases.