Immunic reports low disability worsening rates in MS drug trial

NEW YORK - Immunic, Inc. (NASDAQ:IMUX) announced Tuesday that 92.3% of patients treated with its experimental multiple sclerosis drug vidofludimus calcium remained free of 12-week confirmed disability worsening after 144 weeks of treatment. According to InvestingPro data, the company, currently valued at $68 million, holds more cash than debt on its balance sheet, though analysts note it’s quickly burning through its reserves.

According to data from the open-label extension of the Phase 2 EMPhASIS trial in relapsing-remitting multiple sclerosis, 92.7% of patients were free of 24-week confirmed disability worsening at the same timepoint.

The trial evaluated 182 patients through week 144, representing approximately 952 treatment years. Of the 29 confirmed disability worsening events recorded, 44.8% were associated with relapse-related worsening, while only 13.8% were associated with progression independent of relapse activity.

"The ability to maintain remarkably low rates of disability progression is among the most important unmet needs in relapsing MS despite the availability of multiple anti-inflammatory drugs," said Daniel Vitt, Chief Executive Officer of Immunic, in the press release.

The company reported that the drug maintained its favorable safety and tolerability profile with low discontinuation rates and no new safety signals emerging during treatment durations up to 5.5 years.

Vidofludimus calcium is an oral medication that combines neuroprotective effects through activation of the Nurr1 transcription factor with anti-inflammatory and anti-viral effects via inhibition of the enzyme dihydroorotate dehydrogenase.

The drug is currently in Phase 3 clinical trials for relapsing multiple sclerosis with top-line data expected by the end of 2026.

The Phase 2 EMPhASIS trial initially randomized 268 patients to receive either placebo or different doses of vidofludimus calcium. Of these, 254 continued into the optional open-label extension period, which can last up to 9.5 years.

In other recent news, Immunic, Inc. announced the pricing of its $65 million public offering, which includes pre-funded and series A and B warrants to purchase shares of common stock. The net proceeds are intended to support clinical trials, operations, and other general corporate purposes. Additionally, Immunic has launched a public offering of warrants to fund its ongoing clinical trials, with Leerink Partners as the sole bookrunner. The company also reported positive results from its phase 2 CALLIPER trial for vidofludimus calcium in progressive multiple sclerosis patients, showing a significant reduction in the risk of disability worsening.

Further developments include a registered direct offering of common stock priced at $5.1 million, led by Aberdeen Investments. The proceeds will also be directed towards clinical trials and general corporate functions. William Blair has initiated coverage on Immunic with an Outperform rating, citing the potential of its relapse-remitting multiple sclerosis therapy, vidofludimus calcium. The analyst highlighted the drug’s safety profile and its potential to disrupt the oral RMS therapy market, especially after Sanofi’s recent discontinuation of tolebrutinib.

Immunic’s ongoing ENSURE-1/2 Phase III studies are anticipated to deliver results in 2026, adding to the anticipation surrounding the company’s progress. These recent developments underscore Immunic’s focus on advancing its pipeline and securing the necessary financial resources to support its clinical endeavors.

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