Immunic Inc IMUX shares are surging following a positive clinical readout.
Multiple Sclerosis Study Hits Bulleye: New York-based Immunic, which focuses on developing oral therapies for chronic inflammatory and autoimmune diseases, said its Phase 2 study, dubbed EMPhASIS, that's evaluating its lead asset IMU-838 for relapsing-remitting multiple sclerosis, or RRMS, met all the primary and key secondary endpoints.
The investigational therapy demonstrated a statistically significant reduction in the cumulative number of combined unique active magnetic resonance imaging, or CUI MRI, lesions up to Week 24 in patients receiving 45mg dose, once daily, by 62% as compared to placebo, thus meeting the primary endpoint, the company said.
The secondary endpoint of reduction in the cumulative number of CUA MRI lesions, for the 30mg once-daily dose, by 70% was also met with statistical significance.
Additionally, administration of IMU-838 was found to be safe and well tolerated, with the rate of treatment-emergent adverse event of the treatment arm comparing favorably to the control arm, Immunic said.
"We believe this data strongly supports our goal of developing IMU-838 as an easy, safe and convenient oral treatment option for patients with RRMS and other autoimmune diseases," said Andreas Muehler, Chief Medical Officer of Immunic.
Immunic said analysis of the full EMPhASIS data is ongoing and will be presented at an upcoming scientific meeting.
Immunic's Q2 Results: The company also announced second-quarter results, reporting a narrower loss of 90 cents per share. In the year-ago, the company reported a loss of $1.52 per share.
Analysts, on average, estimated a loss of 69 cents per share for the quarter.
The data clearly validates IMU-838 as a potential treatment for RR-MS, H.C. Wainwright analyst Raghuram Selvaraju said in a note. The analyst reiterated a Buy rating on Immunic shares and raised the price target to from $45 to $60.
Immunic shares were jumping by 28% to $22.
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