Funding to support Immunic Phase 3 MS trials, commercialization
Placement provides up to $400M to advance vidofludimus calcium program
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Three people look at data with graphs and charts.
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Immunic secured $400M to advance trials of vidofludimus calcium in MS.
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The drug targets inflammation and nerve protection.
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Phase 3 trial results in relapsing MS are expected this year.
Immunic Therapeutics has closed a private placement that could provide up to $400 million to support the company’s Phase 3 clinical program of vidofludimus calcium in multiple sclerosis (MS) and help fund its transition into a commercial-stage company as it prepares for potential regulatory approval of the oral therapy.
The financing will support completion of the ongoing Phase 3 ENSURE-1 (NCT05134441) and ENSURE-2 (NCT05201638) trials in relapsing forms of MS. Together, the trials have enrolled more than 2,200 patients. The company expects top-line results by the end of the year.
If the data are positive, the company plans to submit a new drug application (NDA) seeking U.S. approval in mid-2027, with a potential regulatory decision in 2028.
Funds will also support the planned launch of a Phase 3 program in primary progressive MS (PPMS) later this year. The company expects the study to take 3.5 to four years to complete.
Shift to commercial company
The company received $200 million in upfront proceeds from the financing, with the potential for up to an additional $200 million if associated warrants are exercised. The financing was led by existing investor BVF Partners and included several other healthcare investors.
“The proceeds from the initial closing are expected to provide sufficient runway through submission of an NDA in the United States in mid-2027 and to start preparations for the potential launch of vidofludimus calcium in [relapsing MS], as well as initiation of a phase 3 clinical program in PPMS,” Daniel Vitt, PhD, Immunic’s co-founder and CEO, said in a company press release. “We believe that now is the perfect time to prepare Immunic for its transformation into a highly successful commercial entity.”
As part of the company’s transition into a commercial organization, Vitt plans to step down from his role to make way for a new CEO with experience leading commercial companies. He will remain on the company’s board, focusing on strengthening Immunic’s scientific strategy and advancing its pipeline.
“As Immunic evolves from an R&D‑driven organization into a fully-fledged commercial company, I have decided to return to my roots and focus my energy on further strengthening Immunic’s scientific excellence,” Vitt said. “I look forward to welcoming a new CEO with a strong commercial background in the MS space to lead the next phase of Immunic’s growth and to guide the potential launch of our first pharmaceutical product.”
In MS, the immune system mistakenly attacks the myelin sheath, the protective layer surrounding nerve cells in the brain and spinal cord, causing inflammation and nerve damage. These attacks are driven in part by overactive immune cells such as T-cells and B-cells.
Vidofludimus calcium is designed to reduce MS inflammation by blocking an enzyme that these immune cells need to multiply. It also activates Nurr1, a protein thought to support the survival and function of nerve cells.
This dual mechanism is intended to limit immune-mediated damage and provide direct neuroprotective effects, slowing disease progression.
“Despite available therapeutic options in MS, it remains a devastating disease for patients and their families and I am committed to help bring new and meaningful therapies to patients. I believe vidofludimus calcium holds the potential to address the underlying unmet need for a direct neuroprotective medicine in MS,” said Simona Skerjanec, the company’s newly appointed interim chair.
