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Immunic Spikes 35% In Pre-Market On Positive Multiple Sclerosis Data

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Immunic (IMUX) has announced positive top-line data from its phase 2 EMPhASIS trial of lead asset, IMU-838, the company’s selective oral DHODH inhibitor, in patients with relapsing-remitting multiple sclerosis (RRMS). Shares are now spiking 35% in Monday’s pre-market trading.

The study achieved all primary and key secondary endpoints, indicating activity in RRMS patients.

In particular, the study met its primary endpoint, demonstrating a statistically significant reduction in the cumulative number of combined unique active (CUA) magnetic resonance imaging (MRI) lesions up to week 24 in patients receiving 45mg of IMU-838 once daily, by 62% (p=0.0002), as compared to placebo.

The study also met its key secondary endpoint, showing a statistically significant reduction in the cumulative number of CUA MRI lesions for the 30mg once daily dose, by 70% (p<0.0001), as compared to placebo.

All other secondary endpoints, including those based on other MRI parameters and on clinical endpoints such as relapse events, also provided a noticeable signal and numerical benefit for the IMU-838 treatment groups, as compared to placebo.

Moreover, administration of IMU-838 was observed to be safe and well-tolerated with a 42.9% rate of treatment-emergent adverse events vs 43.5% for placebo. Likewise, serious treatment-emergent adverse events were only observed in 3 out of 140 IMU-838-treated patients, and in 1 out of 69 patients on placebo.

The phase 2 EMPhASIS trial was an international, multicenter, double-blind, placebo-controlled, randomized, parallel-group study, designed to assess the efficacy and safety of IMU-838 in patients with RRMS. Of the 210 patients randomized in 36 centers, 209 patients received at least one dose of IMU-838 or placebo, and 197 patients completed the blinded 24-week treatment period.

“Given the strength of these top-line results, we will continue to prepare a clinical phase 3 program for IMU-838 in RRMS and, after a full review of the data, anticipate providing a further update on development strategy” commented Daniel Vitt, CEO of Immunic.

“We are also looking forward to reading out clinical data from the other ongoing phase 2 trials of IMU-838 in COVID-19, primary sclerosing cholangitis and ulcerative colitis in the upcoming months” he added.

Meanwhile the company announced a net loss for the three months ended June 30, 2020 of $11.5 million, or $0.90 per basic and diluted share.

Shares in Immunic have exploded by 77% year-to-date, and analysts have a unanimously bullish outlook on the stock. The Strong Buy Street consensus comes with a $48 average analyst price target, indicating significant further upside potential lies ahead.

According to HC Wainwright analyst Ram Selvaraju the positive top-line data of IMU-838 in RRMS could facilitate a transformative out-licensing deal. For the analyst the next key upcoming catalyst is potential interim clinical data from the CALVID-1 trial, proving the impact of IMU-838 in attenuating viral load in COVID-19-infected patients. (See IMUX stock analysis on TipRanks).

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