Immunic Inc (NASDAQ:IMUX) has announced the completion of enrollment for both Phase 3 ENSURE trials of its lead asset, vidofludimus calcium (IMU-838), in relapsing multiple sclerosis (RMS).
The ENSURE program includes two identical, multicenter, randomized, double-blind Phase 3 trials, ENSURE-1 and ENSURE-2, designed to assess the efficacy, safety, and tolerability of vidofludimus calcium compared to placebo in patients with RMS.
Across more than 100 sites in 15 countries, a total of 1,121 patients in ENSURE-1 and 1,100 in ENSURE-2 were randomized to receive 30 mg daily doses of vidofludimus calcium or placebo.
The primary endpoint for both trials is time to first relapse over 72 weeks, with secondary endpoints including confirmed disability worsening, MRI-based measures, and cognitive assessments.
Topline data from the trials is expected by the end of 2026.
Dr Daniel Vitt, Immunic CEO, said the on-schedule enrollment of the final patients marks another significant milestone for the company’s late-stage MS program.
"We anticipate that the drug's unique neuroprotective effects observed to date will also play a crucial role in the ENSURE trials, where confirmed disability worsening serves as an important secondary outcome,” Dr Vitt said.
“If approved, we believe vidofludimus calcium, with its attractive safety and tolerability profile, compelling dual and novel mechanism of action and combination of neuroprotective, anti-inflammatory, and antiviral effects, could potentially transform the oral MS therapy market, offering a unique first-in-class treatment option by addressing the full spectrum of this disease.
Werner Gladdines, Immunic's chief development officer, added: “We look forward to analyzing the ENSURE top-line data, which we hope will ultimately pave the way for regulatory filings and the ultimate commercialization of vidofludimus calcium in RMS."
New trial data
Additionally, the company on Thursday shared new data from its Phase 2 CALLIPER trial in progressive multiple sclerosis (PMS), which has reinforced previously reported positive topline results.
The updated analysis showed consistent reductions in the risk of 24-week confirmed disability worsening across the overall study population and key disease subtypes. These reductions were observed both in patients with and without signs of active inflammation at baseline.
Immunic said that the findings support vidofludimus calcium’s ability to slow disability progression in a broad range of progressive MS patients.
"Our recently released positive Phase 2 CALLIPER trial data in PMS underlined vidofludimus calcium's neuroprotective potential and its ability to slow disease progression in MS patients with or without focal inflammation,” Dr Vitt said. “We are very excited that additional analyses of time to 24-week confirmed disability worsening further support this potential, highlighting a significant opportunity ahead.”
The CEO added that, because 24-week confirmed disability is an acceptable regulatory endpoint to determine clinical benefit in PMS, this deserves further investigation in a phase 3 program.
Shares of Immunic were up around 4.2% on Thursday morning.